| 1 |
NCT02931981 |
Recruiting |
Serum Dickkopf-4 as a Biomarker for the Diagnosis and Treatment of Gastrointestinal Stromal Tumor |
- Gastrointestinal Stromal Tumor
|
- Procedure: surgery or biopsy
|
Observational |
|
|
Other |
- Observational Model: Case Control
- Time Perspective: Retrospective
|
- Overall Survival
- Relapse-free Survival
|
50 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02931981 |
GIST-DKK4 |
|
October 2016 |
October 2016 |
October 2019 |
October 13, 2016 |
October 13, 2016 |
|
- Ethics Committee of Renji Hospital, School of Medicine,Shanghai Jiaotong University
Shanghai, China
|
| 2 |
NCT00954655 |
Recruiting |
Study of Tumor Samples in Patients Undergoing Treatment for Gastrointestinal Stromal Tumors on Clinical Trial ACOSOG-Z9001 |
- Gastrointestinal Stromal Tumor
|
- Genetic: mutation analysis
- Genetic: polymorphism analysis
- Other: laboratory biomarker analysis
|
Observational |
|
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
|
Other / NIH |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
|
374 |
All |
18 Years and older (Adult, Senior) |
NCT00954655 |
ACOSOG-Z9081
CDR0000631512 |
|
December 2008 |
January 2100 |
|
August 7, 2009 |
August 8, 2017 |
|
- Memorial Sloan Kettering Cancer Center
New York, New York, United States
|
| 3 |
NCT03493152 |
Available
New |
Expanded Access to Everolimus, for an Individual Patient With GIST (Gastrointestinal Stromal Tumors)(CTMS#18-0019) |
- Gastrointestinal Stromal Tumor
|
|
Expanded Access |
|
- The University of Texas Health Science Center at San Antonio
|
Other |
|
|
|
Female |
18 Years and older (Adult, Senior) |
NCT03493152 |
CTMS# 18-0019 |
|
|
|
|
April 10, 2018 |
April 10, 2018 |
|
|
| 4 |
NCT02763748 |
Recruiting |
the Laparoscopic and Endoscopic Cooperative Surgery of Gastrointestinal Stromal Tumor |
- Gastrointestinal Stromal Tumor
|
- Procedure: Laparoscopic endoscopy combined surgery
- Procedure: laparoscopic and endoscopic cooperative surgery
- Procedure: Single-arch laparoscopic and endoscopic cooperative surgery
|
Interventional |
Not Applicable |
- First Affiliated Hospital Xi'an Jiaotong University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Tumor recurrence rate
- the operation time
- the all number of postoperative complications（ frequency,reflux esophagitis and bile reflux gastritis）
|
120 |
All |
Child, Adult, Senior |
NCT02763748 |
XJTU1AF-CRF-2015-019 |
|
June 2016 |
June 2018 |
December 2018 |
May 5, 2016 |
February 7, 2018 |
|
- First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
|
| 5 |
NCT02880020 |
Recruiting |
Nivolumab With or Without Ipilimumab in Treating Patients With Gastrointestinal Stromal Tumor That Is Metastatic or Cannot Be Removed by Surgery |
- Gastrointestinal Stromal Tumor
|
- Biological: Ipilimumab
- Other: Laboratory Biomarker Analysis
- Biological: Nivolumab
|
Interventional |
Phase 2 |
- Jonsson Comprehensive Cancer Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall response rate defined as the number of subjects with a best objective response of confirmed CR or PR divided by the number of subjects
- Clinical benefit rate
- Frequency and severity of AEs assessed by NCI CTCAE v 4.03
- (and 2 more...)
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT02880020 |
16-000525
NCI-2016-01004
P30CA016042 |
|
December 2016 |
September 2018 |
September 2019 |
August 26, 2016 |
January 4, 2018 |
|
- UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
|
| 6 |
NCT02365441 |
Recruiting |
A Randomised Trial of Imatinib Alternating With Regorafenib Compared to Imatinib Alone for the First Line Treatment of Advanced Gastrointestinal Stromal Tumour (GIST) |
- Gastrointestinal Stromal Tumour
|
- Drug: Regorafenib
- Drug: imatinib
|
Interventional |
Phase 2 |
- Australasian Gastro-Intestinal Trials Group
- European Organisation for Research and Treatment of Cancer - EORTC
- Scandinavian Sarcoma Group
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression free survival at 24 months (disease progression or death)
- Objective tumour response rate at 16 weeks
- Clinical benefit rate at 16 weeks
- (and 4 more...)
|
240 |
All |
18 Years and older (Adult, Senior) |
NCT02365441 |
AG1013GST
ACTRN12614000950662 |
ALT GIST |
February 2015 |
December 2019 |
December 2020 |
February 19, 2015 |
October 3, 2016 |
|
- Canberra Hospital
Canberra, Australian Capital Territory, Australia - Calvary Mater Newcastle Hospital
Newcastle, New South Wales, Australia - Prince of Wales Hospital
Sydney, New South Wales, Australia - (and 22 more...)
|
| 7 |
NCT02686944 |
Recruiting |
A Study to Evaluate the Safety of Intuvax Administered Intra-tumorally in Patients With Gastrointestinal Stromal Tumors |
- Gastrointestinal Stromal Tumor
|
- Biological: Intuvax (ilixadencel)
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Changes in vital signs (heart rate, blood pressure, body temperature)
- Changes in lab parameters (hematology and biochemistry) during the study versus baseline
- Adverse events according to CTCAE v 4.03
- (and 9 more...)
|
12 |
All |
18 Years and older (Adult, Senior) |
NCT02686944 |
IM-103
2015-002689-22 |
GIST |
June 2016 |
June 2019 |
June 2019 |
February 22, 2016 |
February 27, 2018 |
|
- Department of Breast and Endocrine Surgery, Section of Endocrine and Sarcoma Surgery, Karolinska University Hospital
Stockholm, Sweden
|
| 8 |
NCT02576080 |
Not yet recruiting |
Efficacy of Imatinib in Patients With Intermediate-risk Gastrointestinal Stromal Tumor With a High-risk Genomic Grade Index |
- Gastrointestinal Stromal Tumor
|
- Drug: Imatinib
- Other: Surveillance
|
Interventional |
Phase 3 |
- Assistance Publique Hopitaux De Marseille
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Rate of metastatic relapse in GIST patient
- Overall survival
- Clinical and biological tolerance
- Patients' quality of life
|
80 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02576080 |
2014-31
2014-005255-87 |
GIGIST |
October 2015 |
October 2019 |
October 2020 |
October 15, 2015 |
October 15, 2015 |
|
|
| 9 |
NCT02443948 |
Recruiting |
Circulating Cell-free Tumor DNA in the Plasma of Patients With Gastrointestinal Stromal Tumors (GIST) |
- Gastrointestinal Stromal Tumor (GIST)
|
- Other: Vena puncture for blood collection
|
Observational |
|
- Fondazione del Piemonte per l'Oncologia
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Correlation of change in cf-DNA levels with disease status in GIST patients harboring specific DNA mutations
- Clearance of cf-DNA levels after surgery in GIST patients harboring specific DNA mutations
- Detection of secondary mutations in KIT, PDGFRα and/or other genes
- (and 3 more...)
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT02443948 |
cf-DNA GIST |
|
June 2014 |
December 2017 |
June 2018 |
May 14, 2015 |
February 14, 2017 |
|
- Fondazione del Piemonte per l'Oncologia
Candiolo, TO, Italy
|
| 10 |
NCT01991379 |
Recruiting |
MEK162 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST) |
- Gastrointestinal Stromal Tumor (GIST)
|
- Drug: MEK162
- Drug: Imatinib Mesylate (Gleevec®; STI571; NSC #716051)
- Other: Blood draws
- Procedure: biopsy
|
Interventional |
Phase 1
Phase 2 |
- Memorial Sloan Kettering Cancer Center
- Array BioPharma
- University of Pittsburgh
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- maximum tolerated dose (MTD) (phase 1b portion)
- Best Response Rate (phase II portion)
- Response Rate (RR) (phase 1b portion)
- (and 3 more...)
|
62 |
All |
18 Years and older (Adult, Senior) |
NCT01991379 |
13-162
R01FD005731 |
|
November 2013 |
November 2021 |
November 2021 |
November 25, 2013 |
March 23, 2018 |
|
- Memorial Sloan Kettering Cancer Center
New York, New York, United States
|
| 11 |
NCT03426722 |
Not yet recruiting |
L-carnitine vs Placebo for the Treatment of Muscle Cramps After Imatinib in Gastrointestinal Stromal Tumors |
- Gastrointestinal Stromal Tumors (GISTs)
|
- Drug: L-carnitine
- Drug: Placebo
|
Interventional |
Phase 3 |
- Asan Medical Center
- Hanmi Pharmaceutical Company Limited
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Proportion of patients who have occurrence of muscle cramps ( numeric rating scale score > 4)
- Change in average numeric rating scale scores of muscle cramps
- Rate of patients who have duration of muscle cramps (numeric rating scale score > 4)
- (and 3 more...)
|
52 |
All |
18 Years and older (Adult, Senior) |
NCT03426722 |
AMC1801 |
|
March 1, 2018 |
March 31, 2019 |
March 31, 2020 |
February 8, 2018 |
February 8, 2018 |
|
|
| 12 |
NCT01933958 |
Recruiting |
Regorafenib Post-marketing Surveillance in Japan |
- Gastrointestinal Stromal Tumors
|
- Drug: Regorafenib (Stivarga, BAY73-4506)
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib.
- Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.
- Number of Patients with serious adverse drug reactions (SADRs) from the first administration of Regorafenib
- (and 4 more...)
|
135 |
All |
Child, Adult, Senior |
NCT01933958 |
16732
STIVARGA-GIST-01 |
|
September 4, 2013 |
June 25, 2021 |
June 25, 2021 |
September 2, 2013 |
April 2, 2018 |
|
- Multiple Locations, Japan
|
| 13 |
NCT01389583 |
Recruiting |
A Study of AUY922 for GIST(Gastrointestinal Stromal Tumor) Patients |
- Gastrointestinal Stromal Tumor
|
|
Interventional |
Phase 2 |
- National Health Research Institutes, Taiwan
- National Taiwan University Hospital
- Taipei Veterans General Hospital, Taiwan
- (and 5 more...)
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- disaese control rate
- response rate
|
25 |
All |
20 Years to 75 Years (Adult, Senior) |
NCT01389583 |
T2211 |
|
October 2011 |
May 2015 |
October 2019 |
July 8, 2011 |
February 25, 2015 |
|
- National Health Research of Institutes, Taiwan Cooperative Oncology Group
Tainan, Taiwan
|
| 14 |
NCT03291054 |
Recruiting |
Epacadostat and Pembrolizumab in Patients With GIST |
- Gastrointestinal Stromal Tumors
|
- Drug: Pembrolizumab
- Drug: Epacadostat
|
Interventional |
Phase 2 |
- Richard D. Carvajal
- Columbia University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Response Rate
- Overall Survival
|
23 |
All |
18 Years and older (Adult, Senior) |
NCT03291054 |
AAAR1581 |
|
January 2018 |
September 2019 |
September 2019 |
September 25, 2017 |
December 26, 2017 |
|
- U-M Comprehensive Cancer Center
Ann Arbor, Michigan, United States - Columbia University Medical Center
New York, New York, United States
|
| 15 |
NCT03404076 |
Recruiting |
Unifying Advanced Treatment With Advanced Imaging |
- Gastrointestinal Stromal Tumor (GIST)
|
- Diagnostic Test: Dual Energy CT
|
Observational |
|
- Heidelberg University
- Institute of Clinical Radiology and Nuclear Medicine Mannheim
- Siemens Healthcare Diagnostics Inc
- Novartis Pharmaceuticals
|
Other / Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Progression free survival after a three year follow-up
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT03404076 |
GIST m3 |
GISTm3 |
December 1, 2014 |
December 1, 2019 |
December 1, 2019 |
January 19, 2018 |
January 19, 2018 |
|
- University Center Mannheim
Mannheim, Germany
|
| 16 |
NCT02401815 |
Recruiting |
PLX9486 as a Single Agent and in Combination With PLX3397 or PLX9486 With Sunitinib in Patients With Advanced Solid Tumors |
- Gastrointestinal Stromal Tumors
|
- Drug: PLX9486
- Drug: PLX3397
- Drug: Sunitinib
|
Interventional |
Phase 1
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety of PLX9486 as measured adverse events and serious adverse events
- Overall response rate
- Progression free survival
- (and 3 more...)
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT02401815 |
PLX121-01 |
|
March 2015 |
August 2019 |
March 2020 |
March 30, 2015 |
March 30, 2018 |
|
- Sylvester Comprehensive Cancer Center/ UMHC
Miami, Florida, United States - Dana-Farber Cancer Institute
Boston, Massachusetts, United States - University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States - (and 3 more...)
|
| 17 |
NCT03353753 |
Recruiting |
Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies |
- Gastrointestinal Stromal Tumors
|
- Drug: DCC-2618
- Drug: Placebo Oral Tablet
|
Interventional |
Phase 3 |
- Deciphera Pharmaceuticals LLC
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Progression free survival (PFS)
- Objective response rate (ORR)
- Time to Tumor Progression (TTP) based on independent radiologic review
- (and 5 more...)
|
120 |
All |
18 Years and older (Adult, Senior) |
NCT03353753 |
DCC-2618-03-001 |
invictus |
February 27, 2018 |
May 2019 |
December 2020 |
November 27, 2017 |
April 17, 2018 |
|
- HonorHealth
Scottsdale, Arizona, United States - UCLA
Los Angeles, California, United States - Stanford
Stanford, California, United States - (and 10 more...)
|
| 18 |
NCT02924714 |
Recruiting |
SSG XXV: The Stop-GIST Trial; Discontinuation of Imatinib in Patients With Oligo-metastatic GIST |
- Gastrointestinal Stromal Tumor
|
- Other: Discontinuation of imatinib
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Progression free survival (PFS)
- Overall survival (OS)
- Quality of Life (QoL)
|
31 |
All |
18 Years and older (Adult, Senior) |
NCT02924714 |
SSG XXV: Stop-GIST |
|
January 2017 |
November 2022 |
November 2022 |
October 5, 2016 |
April 10, 2018 |
|
- Oslo University Hospital
Oslo, Norway
|
| 19 |
NCT02776878 |
Recruiting |
A Clinical Trial Evaluating the Efficacy and Safety of Dasatinib in Refractory Metastatic GIST |
- Gastrointestinal Stromal Tumor
|
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-free survive, calculated from registration until progression or death
- Overall survival, overall survival will be calculated from registration until death
- Adverse drug reactions according to NCI CTCAE v4.0
- (and 2 more...)
|
57 |
All |
18 Years and older (Adult, Senior) |
NCT02776878 |
DRAMA GIST |
|
May 2016 |
October 2017 |
May 2018 |
May 18, 2016 |
May 18, 2016 |
|
- Beijing Cancer Hospital
Beijing, Beijing, China - Chinese PLA General Hospital
Beijing, Beijing, China - The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, China - (and 4 more...)
|
| 20 |
NCT02331914 |
Recruiting |
GIST: Assessment of Tumor Mutations and TKI Plasma Exposure |
- Gastro-intestinal Stromal Tumor
|
- Procedure: Vena puncture for blood collection
- Procedure: Tumor biopsy
|
Observational |
|
- University Medical Center Groningen
- Dutch Cancer Society
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Secondary GIST mutations in circulating tumor DNA of patients with progressive disease on TKI treatment
- Secondary mutations in circulating tumor DNA before progressive disease according RECIST
- Secondary mutations in circulating tumor DNA related to pharmacokinetics of TKI
|
300 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT02331914 |
19082014 |
|
November 2014 |
January 2019 |
January 2019 |
January 6, 2015 |
November 13, 2017 |
|
- Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands - University Medical Center Groningen
Groningen, Netherlands - Leiden University Medical Center
Leiden, Netherlands - (and 2 more...)
|
| 21 |
NCT02508532 |
Recruiting |
Phase 1 Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors |
- Gastrointestinal Stromal Tumors (GIST)
- Other Relapsed or Refractory Solid Tumors
|
|
Interventional |
Phase 1 |
- Blueprint Medicines Corporation
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Part 1: Maximum tolerated dose (MTD) and Recommended Phase 2 dose (RP2D) of avapritinib
- Parts 1 and 2: Number of patients with adverse and serious adverse events and changes in physical findings, vital signs, clinical laboratory results and ECG findings
- Part 2: Overall response rate
- (and 9 more...)
|
250 |
All |
18 Years and older (Adult, Senior) |
NCT02508532 |
BLU-285-1101 |
|
August 2015 |
April 2019 |
May 2019 |
July 27, 2015 |
December 27, 2017 |
|
- Sarcoma Oncology Center
Santa Monica, California, United States - Sylvester Comprehensive Cancer Center
Miami, Florida, United States - Dana Farber Cancer Institute
Boston, Massachusetts, United States - (and 14 more...)
|
| 22 |
NCT02216578 |
Recruiting |
Ph II CABOGIST in GIST |
- Metastatic Gastrointestinal Stromal Tumor
|
|
Interventional |
Phase 2 |
- European Organisation for Research and Treatment of Cancer - EORTC
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression Free Survival (PFS)
- Progression Free Survival (PFS) (RECIST 1.1)
- Overall survival (OS)
- (and 4 more...)
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT02216578 |
EORTC-1317
2014-000501-13 |
|
February 2, 2017 |
August 2019 |
August 2019 |
August 15, 2014 |
April 2, 2018 |
|
- U.Z. Leuven - Campus Gasthuisberg (147)
Leuven, Belgium - University Hospital Motol (1905)
Prague, Czechia - Institut Bergonie (228)
Bordeaux, France - (and 8 more...)
|
| 23 |
NCT02712112 |
Recruiting |
A Study of Intermittent Dosing Schedule of Imatinib in Patients With Tyrosine Kinase Inhibitor Refractory GISTs |
- Gastrointestinal Stromal Tumors (GISTs)
|
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-free survival by the modified RECIST criteria
|
50 |
All |
19 Years and older (Adult, Senior) |
NCT02712112 |
AMC1601 |
|
January 2016 |
December 2018 |
December 2018 |
March 18, 2016 |
January 11, 2018 |
|
- Asan Medical Center
Seoul, Korea, Republic of
|
| 24 |
NCT03471273 |
Recruiting |
Comparison of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor |
- Therapeutic Value of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor
|
- Procedure: endoscopic management, surgery and follow up
|
Interventional |
Not Applicable |
- Nanfang Hospital of Southern Medical University
- Shenzhen Hospital of Southern Medical University
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- recur or not in 2 years after endoscopic surgical procedure or surgery
|
900 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03471273 |
LC2016ZD013 |
CELSGIST |
September 18, 2017 |
October 30, 2021 |
December 31, 2021 |
March 20, 2018 |
March 20, 2018 |
|
- Nanfang Hospistal
Guangzhou, Guangdong, China
|
| 25 |
NCT03092128 |
Recruiting |
A Retrospective Pharmacokinetics and Pharmacogenomics Research of Imatinib in Gastrointestinal Stromal Tumor Treatment |
- Gastrointestinal Stromal Tumors
- Germline Mutation
- Somatic Mutation
- Plasma Concentration
|
|
Observational |
|
- Xueding Wang
- Sun Yat-sen University
|
Other |
- Observational Model: Case-Only
- Time Perspective: Retrospective
|
- Progression free survival
- Number of patients with objective response and adverse events
|
200 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT03092128 |
SYSUCC20141021007 |
|
June 2014 |
June 2018 |
June 2019 |
March 27, 2017 |
March 27, 2017 |
|
- Institute of Clinical Pharmacology, Sun Yat-sen University
Guangzhou, Guangdong, China
|
| 26 |
NCT02949947 |
Recruiting |
Efficacy of Ferric Carboxymaltose in Gastrointestinal Stromal Tumor (GIST) Patients With Iron Deficiency Anemia (IDA) Receiving Systemic Therapy |
- Malignant Neoplasms of Mesothelial and Soft Tissue
- Gastrointestinal Stromal Tumor With Neurogenic Differentiation
|
- Drug: Ferric Carboxymaltose
- Dietary Supplement: Iron Supplements
- Behavioral: Questionnaire
|
Interventional |
Phase 2 |
- M.D. Anderson Cancer Center
- Luitpold Pharmaceuticals
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Complete Response Rate in Hemoglobin (HGB)
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT02949947 |
2015-0588
NCI-2016-01925 |
|
December 18, 2017 |
December 2020 |
December 2021 |
October 31, 2016 |
February 7, 2018 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
| 27 |
NCT01865565 |
Recruiting |
Surgery for Locally Unresectable Advanced GISTs Without Metastasis After Imatinib Therapy |
- Gastrointestinal Stromal Tumor
|
|
Observational |
|
- Chang Gung Memorial Hospital
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- progression free survival
- R0 resection rate
- Objective response rate, tumor shrinkage rate
- (and 4 more...)
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT01865565 |
Yeh CN001 |
|
April 2012 |
April 2018 |
December 2019 |
May 31, 2013 |
May 31, 2013 |
|
- Chang Gung Memorial Hospital
Kwei-Shan, Tao-Yuan, Taiwan
|
| 28 |
NCT02931929 |
Not yet recruiting |
MITIGATE-NeoBOM: A Study to Evaluate 68Ga- NeoBOMB1 in Patients With Advanced TKI-treated GIST Using PET/CT |
- Gastrointestinal Stromal Tumors
|
- Drug: 68Ga-NeoBOMB1, 2-vial kit
|
Interventional |
Phase 1
Phase 2 |
- Medical University Innsbruck
- European Union
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Safety and tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
- Organ and compartment dosimetry data, human pharmacokinetics of 68Ga-NeoBOMB1 and identification of potentially dose-limiting organs
- Preliminary targeting properties of 68Ga-NeoBOMB1 in advanced, GRP positive GIST tumours as assessed by SUV
- (and 4 more...)
|
12 |
All |
21 Years and older (Adult, Senior) |
NCT02931929 |
MITIGATE-NeoBOMB1 |
|
October 2016 |
October 2017 |
October 2017 |
October 13, 2016 |
October 13, 2016 |
|
|
| 29 |
NCT02638766 |
Recruiting |
Single Agent Regorafenib in First-line for Metastatic/Unresectable KIT/PDGFR Wild Type GIST |
- Gastrointestinal Stromal Tumors
|
|
Interventional |
Phase 2 |
- Grupo Espanol de Investigacion en Sarcomas
- Bayer
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Disease Control Rate
- Progression free survival
- Overall survival
- (and 4 more...)
|
39 |
All |
18 Years and older (Adult, Senior) |
NCT02638766 |
REGISTRI (GEIS 40) |
REGISTRI |
November 2015 |
November 2020 |
November 2020 |
December 23, 2015 |
February 23, 2017 |
|
- Policlinico San Orsola Malpighi
Bologna, Italy - A. O. Careggi
Firenze, Italy - Fondazione IRCCS Istituto Dei Tumori di Milano
Milan, Italy - (and 15 more...)
|
| 30 |
NCT02800330 |
Recruiting |
The Effects of the Proton Pump Inhibitor Esomeprazole on the Bioavailability of Regorafenib |
- Colorectal Neoplasms
- Gastrointestinal Stromal Tumors
|
- Drug: Esomeprazole 40mg concomitantly
- Drug: Esomeprazole 40mg before
- Drug: Regorafenib 160mg or 120mg
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- As primary endpoint, AUC of regorafenib alone and AUC of regorafenib with esomeprazole (concomitantly and 3 hours before regorafenib intake, respectively) will be related.
- The Cmax of regorafenib alone and regorafenib with esomeprazole (concomitantly and 3 hours before regorafenib intake respectively) will be related
- Number of participants with treatment related adverse events as assessed by CTCAE v4.0 in absence and presence of esomeprazole
- (and 2 more...)
|
14 |
All |
18 Years and older (Adult, Senior) |
NCT02800330 |
EMC16-165 |
REGORA |
May 2016 |
December 2017 |
February 2018 |
June 15, 2016 |
July 28, 2017 |
|
- Erasmus Medical Center
Rotterdam, South Holland, Netherlands
|
| 31 |
NCT01541709 |
Recruiting |
Imatinib Dose Escalation to 800 mg/Day in Korean Patients With Metastatic or Unresectable GIST Harboring KIT Exon 9 Mutation |
- Gastrointestinal Stromal Tumors
|
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- progression-free survival (PFS)
- disease control rate
- safety control rate
- (and 3 more...)
|
44 |
All |
18 Years and older (Adult, Senior) |
NCT01541709 |
CSTI571BKR24T |
|
March 2012 |
December 2017 |
December 2017 |
March 1, 2012 |
July 14, 2017 |
|
- Asan Medical Center, University of Ulsan College of Medicine
Seoul, Korea, Republic of
|
| 32 |
NCT02260505 |
Recruiting |
Efficiency of Imatinib Treatment Maintenance or Interruption After 3 Years of Adjuvant Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) |
- Gastrointestinal Stromal Tumors
- Resected Gastrointestinal Stromal Tumors
- Non-metastatic
- (and 2 more...)
|
- Drug: Imatinib maintenance
|
Interventional |
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Disease Free Survival (DFS)
- Overall Survival (OS)
- Time to Secondary Resistance (TSR)
- (and 3 more...)
|
256 |
All |
18 Years and older (Adult, Senior) |
NCT02260505 |
IMADGIST
2013-001372-37 |
ImadGist |
December 24, 2014 |
December 2020 |
December 2020 |
October 9, 2014 |
August 7, 2017 |
|
- Institut Paoli-Calmettes
Marseille, Bouches du Rhône, France - Centre Hospitalier Universitaire La Timone
Marseille, Bouches du Rhône, France - CHRU de Besançon - Hôpital Minjoz
Besançon, Doubs, France - (and 13 more...)
|
| 33 |
NCT03082079 |
Not yet recruiting |
Long Outcome of Endoscopic Submucosal Dissection for Small Gastrointestinal Stromal Tumors (<2cm) |
|
|
Interventional |
Not Applicable |
- Nanfang Hospital of Southern Medical University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- progression-free survival
- tumor recurrence rate
- success rate of operations
- (and 7 more...)
|
90 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03082079 |
LC2016YM002 |
|
June 1, 2017 |
August 1, 2021 |
September 30, 2021 |
March 17, 2017 |
May 16, 2017 |
|
|
| 34 |
NCT02734823 |
Recruiting |
Long Term Effects of Tyrosine Kinase Inhibitor Therapy on Ovarian Reserve and Fertility in Patients With Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumor |
- Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Gastrointestinal Stromal Tumor
- Premenopausal
|
- Other: Cytology Specimen Collection Procedure
- Other: Laboratory Biomarker Analysis
- Other: Questionnaire Administration
- Procedure: Ultrasonography
|
Observational |
|
- University of Southern California
- National Cancer Institute (NCI)
|
Other / NIH |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Changes in markers of ovarian reserve in premenopausal women undergoing tyrosine kinase inhibitor therapy for cancer
- Ovarian response to controlled ovarian hyperstimulation in patients who elect to undergo IVF for fertility preservation
|
20 |
Female |
18 Years to 45 Years (Adult) |
NCT02734823 |
0S-15-7
NCI-2016-00352
P30CA014089 |
|
March 1, 2016 |
March 1, 2019 |
March 1, 2020 |
April 12, 2016 |
April 3, 2018 |
|
- USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
|
| 35 |
NCT00700258 |
Recruiting |
Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR] |
- Carcinoma, Renal Cell, Advanced
- Lymphoma, Mantle-Cell
- Gastrointestinal Stroma Tumors
|
- Drug: Temsirolimus
- Drug: Sunitinib
- Drug: Axitinib
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Safety: absolute and relative incidence of adverse events
- Efficacy: best response, progression-free survival, overall survival
- Safety: absolute and relative incidence of therapy interruption
|
1600 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT00700258 |
3066K1-4407
B1771009 |
STAR-TOR |
January 2013 |
December 2023 |
December 2023 |
June 18, 2008 |
January 9, 2018 |
|
- Dr. med. Harald Held
Neumuenster, Schleswig-holstein, Germany - Dr. med. Hans Wilhelm Duebbers
Ahaus, Germany - Dr. Ludwig Fischer von Weikersthal
Amberg, Germany - (and 64 more...)
|
| 36 |
NCT03109301 |
Recruiting |
Mitogen Activated Protein Kinase Kinase (MEK1/2) Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in People With Neurofibromatosis Type 1 (NF1) Mutated Gastrointestinal Stromal Tumors (GIST) |
- Neoplasms, Nerve Tissue
- Neurofibromatosis 1
- Heredodegenerative Disorders, Nervous System
- Peripheral Nervous System Diseases
|
- Drug: Selumetinib (AZD6244 hyd sulfate)
|
Interventional |
Phase 2 |
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To estimate the response rate (radiologic response RECIST v1.1) of selumetinib in children and adults with NF1-mutated measurable gastrointestinal stromal tumor (GIST).
- To describe the toxicities of selumetinib in patients with NF1- mutated GIST.
- To estimate the progression-free survival (PFS).
- To perform a descriptive comparison of the response rate by CT-based imaging criteria developed by Choi compared to response rate as defined by RECIST.
|
20 |
All |
3 Years to 99 Years (Child, Adult, Senior) |
NCT03109301 |
170084
17-C-0084 |
|
April 25, 2018 |
February 1, 2022 |
February 1, 2023 |
April 12, 2017 |
April 20, 2018 |
|
- National Institutes of Health Clinical Center
Bethesda, Maryland, United States
|
| 37 |
NCT01416714 |
Recruiting |
Tissue Procurement for Gastric Cancer, Gastrointestinal Stromal Tumors (GIST), Esophageal Cancer, Pancreas Cancer, Hepatocellular Cancer, Biliary Cancer, Neuroendocrine, Peritoneal Mesothelioma, Anal Cancer and Colorectal Cancer in Patients Undergoing Surgery or Biopsy |
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Collect and store blood samples
- create a database for the collected tissue
- To create tissue microarrays for each gastrointestinal cancer subtype
|
1000 |
All |
Child, Adult, Senior |
NCT01416714 |
16294A |
|
July 2, 2008 |
January 2025 |
January 2025 |
August 15, 2011 |
February 7, 2018 |
|
- The University of Chicago
Chicago, Illinois, United States
|
| 38 |
NCT03465722 |
Not yet recruiting |
(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST |
|
- Drug: avapritinib
- Drug: regorafenib
|
Interventional |
Phase 3 |
- Blueprint Medicines Corporation
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST), version 1.1
- Objective Response Rate (ORR) determined by central radiology assessment per mRECIST, version 1.1
- Overall Survival (OS) in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib
- (and 4 more...)
|
460 |
All |
18 Years to 100 Years (Adult, Senior) |
NCT03465722 |
BLU-285-1303 |
|
March 2018 |
April 2021 |
April 2023 |
March 14, 2018 |
March 14, 2018 |
|
- University of Miami
Miami, Florida, United States - Dana Farber Cancer Institute
Boston, Massachusetts, United States - Sloan Kettering Cancer Center
New York, New York, United States - (and 3 more...)
|
| 39 |
NCT03171389 |
Recruiting |
POETIG Trial - POnatinib After rEsisTance to Imatinib in GIST |
- GIST, Malignant
- KIT Exon 13 Mutation
- KIT Gene Mutation
|
|
Interventional |
Phase 2 |
- Sebastian Bauer
- Hannover Medical School
- Helios Klinikum Berlin
- (and 6 more...)
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- clinical benefit rate (CBR)
- Progression-free survival (PFS)
- Objective response rate (ORR)
- (and 4 more...)
|
81 |
All |
18 Years and older (Adult, Senior) |
NCT03171389 |
POETIG |
POETIG |
March 22, 2017 |
September 22, 2018 |
September 22, 2020 |
May 31, 2017 |
May 31, 2017 |
|
- West German Cancer Center
Essen, NRW, Germany
|
| 40 |
NCT02847429 |
Recruiting |
Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST |
- GIST With D842V Mutated PDGFRA Gene
|
- Drug: Crenolanib
- Drug: Placebo
|
Interventional |
Phase 3 |
- Arog Pharmaceuticals, Inc.
- Centre Leon Berard
- Fox Chase Cancer Center
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Progression-free survival (PFS) will be measured from the date of randomization to the date of the first objective radiological disease progression according to centralized committee assessment using modified RECIST version 1.1 or death.
- Overall survival (OS) will be measured from the date of randomization to the date of death from any cause. OS will be estimated using the Kaplan-Meier method.
|
120 |
All |
18 Years and older (Adult, Senior) |
NCT02847429 |
ARO-012 |
|
August 2016 |
August 2019 |
August 2019 |
July 28, 2016 |
March 16, 2018 |
|
- Sarcoma Oncology Center
Santa Monica, California, United States - University of Miami
Miami, Florida, United States - Duke Cancer Institute
Durham, North Carolina, United States - (and 20 more...)
|
| 41 |
NCT02866045 |
Recruiting |
EUS-FNB vs. Single-incision Needle-knife (SINK) Biopsy for Gastrointestinal SELs |
- Disorder of Upper Gastrointestinal Tract
- Gastrointestinal Stromal Tumors
- Gastrointestinal Neoplasms
|
- Procedure: EUS-guided fine needle biopsy
- Procedure: Single incision needle knife biopsy
|
Interventional |
Phase 3 |
- St. Michael's Hospital, Toronto
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Diagnostic
|
- Proportion of patients receiving a definitive histologic diagnosis for gastrointestinal SELs by single incision needle-knife biopsy (SINK biopsy) vs. EUS-guided fine needle biopsy (EUS-FNB).
- Adverse events with SINK biopsy vs. EUS-FNB
- Procedure time with SINK biopsy vs. EUS-FNB
- (and 2 more...)
|
104 |
All |
18 Years and older (Adult, Senior) |
NCT02866045 |
16-030 |
|
May 2016 |
April 2018 |
December 2018 |
August 15, 2016 |
August 15, 2016 |
|
- St. Michael's Hospital
Toronto, Ontario, Canada
|
| 42 |
NCT02571036 |
Recruiting |
A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies |
- Gastrointestinal Stromal Tumors
- Aggressive Systemic Mastocytosis
- Advanced Cancers
|
|
Interventional |
Phase 1 |
- Deciphera Pharmaceuticals LLC
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Dose limiting toxicities, AEs, SAEs, discontinuation of drug due to toxicity, physical exams and ECOG PS, ophthalmologic examinations, changes from baseline in laboratory parameters, electrocardiograms, LVEF, and vital signs.
- Determination of the Maximum Tolerated Dose and the Recommended Phase 2 Dose
- Maximum plasma concentration of DCC-2618 (Tmax)
- (and 12 more...)
|
250 |
All |
18 Years and older (Adult, Senior) |
NCT02571036 |
DCC-2618-01-001 |
|
October 2015 |
June 2018 |
December 2018 |
October 8, 2015 |
January 31, 2018 |
|
- Honor Health
Scottsdale, Arizona, United States - UCLA (malignant gliomas only)
Los Angeles, California, United States - Stanford (GIST & mastocytosis only)
Palo Alto, California, United States - (and 14 more...)
|
| 43 |
NCT03411915 |
Recruiting |
A Study of XmAb®18087 in Subjects With NET and GIST |
- Neuroendocrine Tumor
- Gastrointestinal Neoplasm
|
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Determine the safety and tolerability profile of XmAb18087
- Identify the maximum tolerated dose (MTD) and/or recommended dose (RD) and schedule of XmAb18087
|
87 |
All |
12 Years and older (Child, Adult, Senior) |
NCT03411915 |
XmAb18087-01
DUET-1 |
|
January 22, 2018 |
March 2021 |
June 2021 |
January 26, 2018 |
April 2, 2018 |
|
- City of Hope Medical Center
Duarte, California, United States - Emory University
Atlanta, Georgia, United States - MD Anderson Cancer Center
Houston, Texas, United States
|
| 44 |
NCT01048281 |
Recruiting |
Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma |
- Stomach Cancer
- Gastro-Esophageal(GE) Junction Cancer
- Gastric (Stomach) Cancer
- (and 2 more...)
|
- Procedure: Blood draw
- Procedure: Tissue tumor biopsy
|
Observational |
|
- Stanford University
- National Institutes of Health (NIH)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- p53 activity by routine pathologic analysis
- NER activity by routine pathologic analysis
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT01048281 |
GIUPR0001
76274
CA109190
SU-11022007-787 |
|
August 2002 |
January 2099 |
January 2099 |
January 13, 2010 |
July 14, 2016 |
|
- Stanford University School of Medicine
Stanford, California, United States
|
| 45 |
NCT03165721 |
Recruiting |
A Phase II Trial of the DNA Methyl Transferase Inhibitor, Guadecitabine (SGI-110), in Children and Adults With Wild Type GIST,Pheochromocytoma and Paraganglioma Associated With Succinate Dehydrogenase Deficiency and HLRCC-associated Kidney Cancer |
- Paraganglioma
- Gastrointestinal Stromal Tumors
- Carcinoma, Renal Cell
- (and 2 more...)
|
- Drug: SGI-110 (guadecitabine)
|
Interventional |
Phase 2 |
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Assess clinical activity of SGI-11 using RECIST
|
70 |
All |
12 Years to 99 Years (Child, Adult, Senior) |
NCT03165721 |
170088
17-C-0088 |
|
August 16, 2017 |
December 1, 2020 |
December 1, 2021 |
May 24, 2017 |
March 21, 2018 |
|
- National Institutes of Health Clinical Center
Bethesda, Maryland, United States
|
| 46 |
NCT02500797 |
Recruiting |
Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery |
- Dedifferentiated Liposarcoma
- Gastrointestinal Stromal Tumor
- Metastatic Liposarcoma
- (and 9 more...)
|
- Biological: Ipilimumab
- Other: Laboratory Biomarker Analysis
- Biological: Nivolumab
- Other: Quality-of-Life Assessment
|
Interventional |
Phase 2 |
- National Cancer Institute (NCI)
|
NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Confirmed response rate estimated as the number of patients having a best objective tumor status of complete response (CR) or partial response (PR) lasting at least 4 weeks, divided by the number of evaluable patients
- Adverse event (AE) rates graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 beginning April 1, 2018)
- Duration of response
- (and 3 more...)
|
195 |
All |
18 Years and older (Adult, Senior) |
NCT02500797 |
NCI-2015-00260
A091401
U10CA180821 |
|
July 30, 2015 |
January 30, 2022 |
|
July 17, 2015 |
April 17, 2018 |
|
- Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States - Anchorage Radiation Therapy Center
Anchorage, Alaska, United States - Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States - (and 627 more...)
|
| 47 |
NCT02834013 |
Recruiting |
Nivolumab and Ipilimumab in Treating Patients With Rare Tumors |
- Acinar Cell Carcinoma
- Adenoid Cystic Carcinoma
- Adrenal Cortex Carcinoma
- (and 82 more...)
|
- Procedure: Biospecimen Collection
- Biological: Ipilimumab
- Biological: Nivolumab
|
Interventional |
Phase 2 |
- National Cancer Institute (NCI)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall response rate (ORR) defined as confirmed and unconfirmed complete and partial response
- Incidence of adverse events graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- Best response calculated from the sequence of RECIST 1.1 and immune-related response criteria (irRC) objectives
- (and 3 more...)
|
707 |
All |
18 Years and older (Adult, Senior) |
NCT02834013 |
NCI-2016-01041
S1609
U10CA180888 |
|
January 13, 2017 |
August 31, 2020 |
|
July 15, 2016 |
April 17, 2018 |
|
- University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States - University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States - Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States - (and 815 more...)
|
| 48 |
NCT02106858 |
Recruiting |
Stivarga Regulatory Post-Marketing Surveillance Study in Korea |
|
- Drug: Regorafenib (Stivarga,BAY73-4506)
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Percentage of patients with serious adverse events
- Percentage of patients with adverse drug reactions (ADRs)
- Overall response
- (and 2 more...)
|
3750 |
All |
Child, Adult, Senior |
NCT02106858 |
16778
SV1314KR |
StivargaPMS |
June 25, 2014 |
May 7, 2019 |
May 7, 2019 |
April 8, 2014 |
April 12, 2018 |
|
- Multiple Locations, Korea, Republic of
|
| 49 |
NCT02071862 |
Recruiting |
Study of the Glutaminase Inhibitor CB-839 in Solid Tumors |
- Solid Tumors
- Triple-Negative Breast Cancer
- Non Small Cell Lung Cancer
- (and 7 more...)
|
- Drug: CB-839
- Drug: Pac-CB
- Drug: CBE
- (and 3 more...)
|
Interventional |
Phase 1 |
- Calithera Biosciences, Inc
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety and tolerability of CB-839: Incidence of adverse events
- Pharmacokinetics: Area under the Curve (AUC) of CB-839 concentration in blood
- Pharmacodynamics: % inhibition of glutaminase in blood
- Clinical activity: Change in tumor volume from baseline
|
205 |
All |
18 Years and older (Adult, Senior) |
NCT02071862 |
CX-839-001 |
|
February 2014 |
June 2017 |
September 2017 |
February 26, 2014 |
August 22, 2016 |
|
- UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States - Stanford University Medical Center
Stanford, California, United States - Florida Cancer Specialists
Sarasota, Florida, United States - (and 10 more...)
|
| 50 |
NCT02982486 |
Not yet recruiting |
A Phase II of Nivolumab Plus Ipilimumab in Non-resectable Sarcoma and Endometrial Carcinoma |
- Soft Tissue Sarcoma
- Bone Sarcoma
- Chondrosarcoma
- (and 5 more...)
|
- Drug: Ipilimumab
- Drug: Nivolumab
|
Interventional |
Phase 2 |
- Assaf-Harofeh Medical Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Response to therapy as evaluated by RECIST 1.1
- Median Progression-free survival (PFS)
- Progression-free survival (PFS) assessed at 12 weeks
- (and 2 more...)
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT02982486 |
0239/16 |
|
December 2017 |
June 2020 |
December 2020 |
December 5, 2016 |
November 1, 2017 |
|
|
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