1 |
NCT00478686 |
Completed |
Association of Dihydropyrimidine Dehydrogenase (DPYD) Variants With Toxicity Related to Capecitabine |
|
|
Observational |
|
- M.D. Anderson Cancer Center
- Myrexis Inc.
|
Other / Industry |
- Observational Model: Case-Control
- Time Perspective: Retrospective
|
- Incidence of DPYD variants in patients
|
102 |
All |
Child, Adult, Senior |
NCT00478686 |
2006-1003 |
|
May 23, 2007 |
May 2, 2017 |
May 2, 2017 |
May 25, 2007 |
May 8, 2017 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
2 |
NCT00838370 |
Completed |
Pharmacogenomic and Pharmacokinetic Safety and Cost-saving Analysis in Patients Treated With Fluoropyrimidines |
|
- Drug: Capecitabine, 5-fluorouracil
|
Interventional |
Phase 1 |
- The Netherlands Cancer Institute
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
|
22 |
All |
18 Years and older (Adult, Senior) |
NCT00838370 |
NKI-AVL_M07PFU |
|
May 2007 |
October 2011 |
October 2011 |
February 6, 2009 |
March 4, 2014 |
|
- Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands - Slotervaart Hospital
Amsterdam, Netherlands - Canisius Wilhelmina Hospital
Nijmegen, Netherlands
|
3 |
NCT02324452 |
Recruiting |
Safety, Feasibility and Cost-effectiveness of Genotype-directed Individualized Dosing of Fluoropyrimidines |
|
- Drug: Fluoropyrimidine (capecitabine or 5-fluorouracil)
|
Interventional |
Not Applicable |
- The Netherlands Cancer Institute
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety: incidence of severe treatment-related toxicity (CTC grade 3 to 5)
- Cost-effectiveness: medical costs that are made during fluoropyrimidine treatment seen from a health care perspective
- DPD phenotype, defined as deficient or not deficient
- Assessment of pharmacokinetics: Such profile parameters will include Cmax, Tmax, AUC and elimination half-life
|
1250 |
All |
18 Years and older (Adult, Senior) |
NCT02324452 |
M14DPD 2014-005064-15 |
|
March 2015 |
December 2017 |
March 2018 |
December 24, 2014 |
August 21, 2017 |
|
- MC Slotervaart
Amsterdam, Netherlands - Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands - Wilhelmina Hospital Assen
Assen, Netherlands - (and 16 more...)
|
4 |
NCT01641458 |
Completed |
Pharmacology-driven Dosing of Fluoropyrimidines in Cancer Patients |
|
- Other: 5FU and capecitabine (Xeloda®) dosing based on DPYD genotype
- Other: Therapeutic drug monitoring of 5FU
|
Interventional |
Phase 4 |
- Cantonal Hospital of St. Gallen
- University of Bern
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Predefined fluoropyrimidine-related (index) toxicity
- Area-under-the plasma-concentration time curve of 5-fluorouracil
- Endogenous dihydrouracil/uracil ratio in plasma
- (and 2 more...)
|
37 |
All |
18 Years and older (Adult, Senior) |
NCT01641458 |
SG 343/12 |
FLOXTOX2 |
October 2012 |
November 2015 |
November 2015 |
July 16, 2012 |
February 2, 2016 |
|
- Inselspital
Bern, Switzerland - Cantonal Hospital
St.Gallen, Switzerland
|
5 |
NCT02718664 |
Active, not recruiting |
Food-effect Study on Uracil and Dihydrouracil Levels as a Diagnostic Marker of Dihydropyrimidine Dehydrogenase Activity |
|
- Other: Test meal (breakfast)
|
Interventional |
Not Applicable |
- The Netherlands Cancer Institute
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Uracil levels (ng/ml) and dihydrouracil levels (ng/ml), compared in fed and fasting condition
- dihydropyrimidine dehydrogenase enzyme activity (nmol/mg*h)
|
16 |
All |
18 Years and older (Adult, Senior) |
NCT02718664 |
N16URA |
|
April 2016 |
June 2017 |
December 2017 |
March 24, 2016 |
August 21, 2017 |
|
- The Netherlands Cancer Institute
Amsterdam, Netherlands
|
6 |
NCT03205735 |
Recruiting |
The Enzymatic Activity of Lymphocyte Dihydropyrimidine Dehydrogenase DPD in the Blood as a Predictive and Prognostic Factor in Patients With Digestive Cancer in the First or Second Metastatic Line |
- Metastatic or Locally-advanced Digestive Cancer
|
- Diagnostic Test: lymphocyte DPD dosage
|
Observational |
|
- Centre Antoine Lacassagne
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- progression free survival
- overall survival
- treatment response
- toxicities evaluation
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT03205735 |
2017/25 |
DPD DIG |
June 29, 2017 |
June 29, 2019 |
September 29, 2019 |
July 2, 2017 |
July 6, 2017 |
|
- Centre Antoine Lacassagne
Nice, France
|
7 |
NCT00264446 |
Completed |
A Study of ADH300004 in Surgically Resected Primary or Metastatic Colorectal Cancer and Liver Biopsy, or Planned Hepatic Resection |
|
|
Interventional |
Phase 1 |
- Adherex Technologies, Inc.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
|
All |
19 Years and older (Adult, Senior) |
NCT00264446 |
Adherex Protocol # AHX-03-101 |
|
|
|
|
December 13, 2005 |
August 6, 2007 |
|
- UAB - Division of Surgery
Birmingham, Alabama, United States
|
8 |
NCT01608646 |
Recruiting |
Study of DPD for Predicting Efficacy and Safety to S-1 Plus Oxaliplatin in Gastrointestinal Cancer |
|
- Drug: S-1 plus oxaliplatin
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective tumor response
- Overall survival
- Progress-free survival
- Adverse event incidence
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT01608646 |
TOTTG270105 |
|
March 2012 |
August 2013 |
August 2018 |
May 31, 2012 |
May 31, 2012 |
|
- Xijing hospital of the fourth military medical univercity
Xijing, Shanxi, China
|
9 |
NCT01547923 |
Unknown † |
Pre-therapeutic Identification of Dihydropyrimidine Dehydrogenase Gene (DPD) Deficiency for Predicting Toxicity to Fluoropyrimidines |
- Colorectal Cancer
- Intravenous 5 Fluorouracile
|
- Genetic: Blood sample for phenotypic and pharmacogenetic analysis.
|
Interventional |
Phase 3 |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number and nature of grade IV toxicity.
- Number of grade III-IV toxic events.
- Mortality rate.
- Medical-financial study of pre-therapeutic screening.
|
2296 |
All |
18 Years and older (Adult, Senior) |
NCT01547923 |
CPP-380 2008-000026-39 |
DPD côlon |
June 2008 |
December 2012 |
December 2012 |
March 8, 2012 |
March 8, 2012 |
|
- ICO Paul Papin
Angers, France - CHU Jean Minjoz
Besançon, France - CHU Morvan
Brest, France - (and 22 more...)
|
10 |
NCT00953537 |
Completed |
Predicting Response to Capecitabine in Women With Metastatic Breast Cancer |
|
- Drug: capecitabine
- Other: laboratory biomarker analysis
- Other: pharmacological study
|
Interventional |
Not Applicable |
- Centre Antoine Lacassagne
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Capecitabine-related toxicity (i.e., hematological, diarrhea, and hand-foot syndrome) recorded during the first and second courses
|
303 |
Female |
18 Years and older (Adult, Senior) |
NCT00953537 |
CDR0000638377 CALACASS-DPD-Sein 2008/21 INCA-RECF0942 EUDRACT-2008-004136-20 |
|
January 2009 |
January 2011 |
February 2011 |
August 6, 2009 |
February 10, 2015 |
|
- Centre Antoine Lacassagne
Nice, France
|
11 |
NCT00004195 |
Completed |
Eniluracil and Surgery in Treating Patients With Primary or Metastatic Colorectal Cancer |
|
- Drug: eniluracil
- Procedure: conventional colon surgery
|
Interventional |
Phase 2 |
- University of Alabama at Birmingham
- National Cancer Institute (NCI)
- Glaxo Wellcome
|
Other / NIH / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Primary Goal to demonstrate that eniluracil at current clinical doses
- Evaluate DPD recovery and uracil levels
|
28 |
All |
19 Years to 80 Years (Adult, Senior) |
NCT00004195 |
CDR0000067438 F980826006 |
|
September 1998 |
October 1999 |
May 2001 |
September 16, 2004 |
June 15, 2015 |
|
|
12 |
NCT00400023 |
Completed |
A Phase 1, Open-Label, Randomized, Cross-Over, Pharmacokinetic Study Evaluating the Effect of S-1 on Advanced Solid Tumors |
|
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Cross-Over Pharmacokinetic Phase: To compare plasma concentrations, investigate the plasma and urine pharmacokinetic profiles, and to evaluate the duration of DPD inhibition after the administration of S-1
- S-1 Extension Phase: Efficacy (antitumor response)
- S-1 Extension Phase: Safety (Adverse events, lab assessments)
- S-1 Extension Phase: Pharmacokinetic profiles of the components of S-1 and their metabolites, and duration of DPD inhibition after administration of multiple doses (end of Cycle 1)
|
12 |
All |
18 Years and older (Adult, Senior) |
NCT00400023 |
TPU-S1108 |
|
September 2006 |
May 2007 |
May 2007 |
November 16, 2006 |
April 11, 2011 |
|
- Premiere Oncology of Arizona
Scottsdale, Arizona, United States - Premiere Oncology, A Medical Corporation
Santa Monica, California, United States - Yale Cancer Center
New Haven, Connecticut, United States
|
13 |
NCT01402115 |
Completed Has Results |
A 12-week Human Trial to Compare the Efficacy and Safety of Polycan on Bone Metabolism |
- Bone Health in Perimenopausal Women
|
- Dietary Supplement: Polycan
- Dietary Supplement: Placebo
|
Interventional |
Phase 2 Phase 3 |
- Chonbuk National University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Supportive Care
|
- Changes in DPD(Deoxypyridinoline)
- Changes in OSC(Osteocalcin)
- Changes in CTx(Collagen Type 1 Cross-linked C-telopeptide)
- (and 2 more...)
|
60 |
Female |
40 Years to 70 Years (Adult, Senior) |
NCT01402115 |
Glu-POLYCAN-001 |
|
November 2008 |
February 2009 |
May 2009 |
July 26, 2011 |
October 12, 2012 |
October 5, 2012 |
- Healthcare claims and management; Chonbuk National university
Jeonju, Jeollabuk-do, Korea, Republic of
|
14 |
NCT00366860 |
Completed |
Effect of Soy Bread on Markers of Bone Metabolism and Cardiovascular Disease |
- Osteoporosis
- Cardiovascular Diseases
|
|
Interventional |
Phase 1 |
- University of Michigan
- Ohio State University
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- deoxypyridinoline
- N-telopeptides, bone-specific alkaline phosphatase, osteocalcin, cholesterol, triglycerides, apolipoproteins, C-reactive protein, HbA1c
|
18 |
All |
50 Years and older (Adult, Senior) |
NCT00366860 |
GCRC Protocol #1971 |
|
January 2004 |
May 2008 |
May 2008 |
August 21, 2006 |
December 2, 2014 |
|
- University of Michigan
Ann Arbor, Michigan, United States
|
15 |
NCT03093818 |
Recruiting |
PREemptive Pharmacogenomic Testing for Preventing Adverse Drug REactions |
|
- Other: Pharmacogenomic testing
|
Interventional |
Not Applicable |
- J.J.Swen
- University of Liverpool
- Medical University of Vienna
- (and 14 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Experience of at least one clinically relevant adverse drug reaction which is caused by the drug of inclusion
- Physician and pharmacist adherence to Dutch Pharmacogenomics Working Group guidelines
- Healthcare expenditure related to adverse events
- (and 5 more...)
|
8100 |
All |
18 Years and older (Adult, Senior) |
NCT03093818 |
668353 (U-PGx) |
PREPARE |
March 20, 2017 |
December 2019 |
December 2019 |
March 28, 2017 |
April 18, 2017 |
|
- Medical University of Vienna
Vienna, Austria - University of Patras
Patras, Greece - Centro di Riferimento Oncologico
Aviano, Italy - (and 4 more...)
|
16 |
NCT00264472 |
Suspended |
A Study of 5 Fluorouracil and the Anti-Tumor Activity of ADH300004 and 5 Fluorouracil in Subjects With Incurable Solid Tumors |
|
|
Interventional |
Phase 1 |
- Adherex Technologies, Inc.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Part 1: To determine the DLTs and MTD of the combination of ADH300004 and 5 FU administered orally in a weekly regimen, for 3 weeks with 1 week rest per cycle, in subjects with incurable solid tumors
- Part 2: To determine the DLTs and MTD of the combination of ADH300004 and 5-FU administered orally as a split dose for 3 out of 4 weeks in subjects with HCC, NSCLC, gastric cancer, cervical cancer, prostate cancer, and breast cancer
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT00264472 |
Adherex Protocol # AHX-03-104 |
|
January 2006 |
June 2009 |
|
December 13, 2005 |
December 15, 2008 |
|
- Sarah Cannon Research Institute
Nashville, Tennessee, United States
|
17 |
NCT00319683 |
Terminated |
A Study of ADH300004 and 5-Fluorouracil in Locally Advanced, Recurrent, or Metastatic Hepatocellular Carcinoma |
|
|
Interventional |
Phase 1 Phase 2 |
- Adherex Technologies, Inc.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
|
All |
18 Years and older (Adult, Senior) |
NCT00319683 |
AHX-03-103 |
|
|
|
|
April 27, 2006 |
December 15, 2008 |
|
- Queens Medical Center
Honolulu, Hawaii, United States - Johns Hopkins Singapore International Medical Center
Singapore, Singapore - Chang Gung Memorial Hospital
Chiayi, Taiwan - (and 4 more...)
|
18 |
NCT00660686 |
Completed |
Exercise for Physical Health in Men With Prostate Cancer |
- Prostatic Neoplasm
- Osteoporosis
|
- Behavioral: Resistance Exercise
- Behavioral: Flexibility Training
|
Interventional |
Not Applicable |
- OHSU Knight Cancer Institute
- Lance Armstrong Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Supportive Care
|
- bone mineral density, bone turnover markers (serum osteocalcin, urinary deoxypyridinoline cross-links), muscle mass, fat mass.
- maximal muscle strength, gait, balance, self-report physical function, symptoms
|
56 |
Male |
18 Years to 100 Years (Adult, Senior) |
NCT00660686 |
387 |
|
January 2006 |
January 2009 |
January 2009 |
April 17, 2008 |
October 21, 2015 |
|
- OHSU School of Nursing
Portland, Oregon, United States
|
19 |
NCT00384306 |
Completed |
Effects Of Oral Prednisolone On Bone Metabolism In Patients With Chronic Obstructive Pulmonary Disease |
- Chronic Obstructive Pulmonary Disease
|
|
Interventional |
Phase 1 |
- GlaxoSmithKline
- University of Cambridge
|
Industry / Other |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Mineral apposition rate Mineralising surface Eroded surface Bone formation rate Osteocalcin levels Serum and urinary deoxypyridinoline
- Pharmacokinetic measurements Bone structure and micro computer tomography of bone biopsies Biochemical markers of bone formation, bone break down and hormones
|
9 |
All |
40 Years to 75 Years (Adult, Senior) |
NCT00384306 |
RES11086 |
|
June 2004 |
January 2006 |
January 2006 |
October 6, 2006 |
April 16, 2015 |
|
- GSK Clinical Trials Call Centre
Cambridge, United Kingdom
|
20 |
NCT00659906 |
Completed |
Optimizing Body Composition & Health After Breast Cancer |
- Breast Neoplasm
- Osteoporosis, Postmenopausal
|
- Behavioral: Resistance Exercise
- Behavioral: Flexibility Training
|
Interventional |
Not Applicable |
- OHSU Knight Cancer Institute
- American Cancer Society, Inc.
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Supportive Care
|
- Bone mineral density (lumbar spine, proximal femur), bone turnover markers (serum osteocalcin, urinary deoxypyridinoline cross-links) muscle mass, fat mass.
- Maximal muscle strength, leg power, gait, balance, self-report physical function and symptoms
|
71 |
Female |
Child, Adult, Senior |
NCT00659906 |
621 |
|
January 2006 |
January 2009 |
January 2009 |
April 17, 2008 |
May 28, 2015 |
|
- OHSU School of Nursing
Portland, Oregon, United States
|
21 |
NCT01650766 |
Unknown † |
Study of S1 Efficacy and Toxicity as Second-line Treatment on Inoperable or Advanced Gastric Cancers |
|
|
Observational |
|
- The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
|
80 |
All |
18 Years and older (Adult, Senior) |
NCT01650766 |
AGC-307PLAH-XJM |
|
February 2012 |
|
October 2012 |
July 26, 2012 |
July 26, 2012 |
|
- 307 Hospital of PLA
Beijing, Beijing, China
|
22 |
NCT00244478 |
Completed |
Soy, Bone and Health in College Females |
|
- Dietary Supplement: Soy Protein Dietary Supplement
- Dietary Supplement: Placebo
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Bone specific alkaline phosphatase, N-telopeptide, osteocalcin, pyridinoline, deoxypyridinoline, height, weight, waist circumference, fat mass, fat-free soft tissue mass and bone mass will be measured at baseline, 8- and 16-weeks.
- Leptin, adipose tissue vascular endothelial growth factors, angiopoietins, and cytokines will be measured in the serum at baseline, 8- and 16-weeks. The impact of soy on satiety and depression will be measured at baseline, 8- and 16-weeks.
|
120 |
Female |
18 Years to 19 Years (Adult) |
NCT00244478 |
10-20-2005-FOCUS |
|
October 2005 |
March 2006 |
March 2006 |
October 26, 2005 |
September 25, 2015 |
|
- The University of Georgia
Athens, Georgia, United States
|
23 |
NCT01074996 |
Unknown † |
Study of S-1 as Second Line Treatment on Advanced Pancreatic Cancers |
|
- Drug: S-1
- Drug: S-1 plus Leucovorin
|
Interventional |
Phase 2 |
- The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression Free Survival(PFS)
- overall survival
- Tumor response rate
- (and 2 more...)
|
92 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01074996 |
APC-307PLAH-XJM |
APC-S1 |
February 2010 |
October 2013 |
July 2014 |
February 24, 2010 |
January 16, 2014 |
|
- 307 Hospital of PLA
Beijing, Beijing, China
|
24 |
NCT00399802 |
Completed Has Results |
A Study to Examine the Effects of an Experimental Drug on Women With Breast Cancer and Metastatic Bone Disease (MBD)(0822-016)(COMPLETED) |
- Breast Cancer
- Metastatic Bone Disease
|
- Drug: ZA
- Drug: Odanacatib
- Drug: Odanacatib matching placebo
- Drug: ZA matching placebo
|
Interventional |
Phase 2 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4
- Number of Participants Who Experienced an Adverse Event (AE)
- Number of Participants Who Discontinued Treatment Due to an AE
- Percentage Change From Baseline in Urinary Deoxypyridinoline (u-DPD) at Week 4
|
43 |
Female |
18 Years and older (Adult, Senior) |
NCT00399802 |
0822-016 2006_533 MK-0822-016 |
|
November 16, 2006 |
December 5, 2007 |
December 5, 2007 |
November 15, 2006 |
March 1, 2018 |
February 1, 2018 |
|
25 |
NCT01849380 |
Not yet recruiting |
Neoadjuvant ECS Versus ECF in Local Advanced Breast Cancer |
- Breast Neoplasms
- Neoadjuvant Therapy
|
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pathological complete response
- Disease-free Survival
- Tolerability and safety
|
240 |
Female |
18 Years to 70 Years (Adult, Senior) |
NCT01849380 |
BEST T-01 |
|
June 2013 |
October 2013 |
June 2018 |
May 8, 2013 |
May 8, 2013 |
|
- the Second Hospital of Shandong Universtity
Jinan, Shandong, China
|
26 |
NCT00197431 |
Unknown † |
Pharmacokinetic and Pharmacodynamic Study of S-1 in Patients With Digestive Organ Cancer |
- Gastric Cancer
- Esophageal Cancer
- Pancreatic Cancer
- Colon Cancer
|
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Whether the differences in activities of CYP2A6 and DPD affect pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes
- Side effect and motility of patients treated with S-1
|
|
All |
20 Years to 85 Years (Adult, Senior) |
NCT00197431 |
S-12005 |
|
January 2004 |
|
|
September 20, 2005 |
March 22, 2006 |
|
- Hamamatsu University School of Medicine
Hamamatsu, Shizuoka, Japan
|
27 |
NCT01504802 |
Completed |
Pharmacodynamics of CNP During Growth Hormone Treatment |
- Pituitary Dwarfism
- Idiopathic Short Stature
|
|
Observational |
|
- Nemours Children's Clinic
- Children's Hospital Los Angeles
- Novo Nordisk A/S
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Determine the time after starting rhGH that NTproCNP level reaches 95% of its peak level
- Correlate NTproCNP levels at the time it reaches 95% of its peak with six-month and one year growth velocity on rhGH treatment
- Compare NTproCNP levels with other biomarkers of growth (serum IGF-I, bone-specific alkaline phosphatase, and leptin, and urine deoxypyridinoline) during rhGH treatment
|
22 |
All |
3 Years and older (Child, Adult, Senior) |
NCT01504802 |
NCC 167624 |
|
November 2010 |
March 2013 |
September 2014 |
January 5, 2012 |
October 2, 2014 |
|
- Children's Hospital Los Angeles
Los Angeles, California, United States - Nemours Children Clinic
Jacksonville, Florida, United States
|
28 |
NCT00378820 |
Unknown † |
The Effect of Whey and Casein on IGFs in Prepubertal Boys |
- Metabolic Syndrome
- Obesity
|
- Behavioral: Whey without milk minerals
- Behavioral: Whey with milk minerals
- Behavioral: Casein without milk minerals
- Behavioral: Casein with milk minerals
|
Interventional |
Not Applicable |
- University of Copenhagen
- ARLA Ingredients a.m.b.a.
|
Other |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Double
- Primary Purpose: Prevention
|
- IGF-I
- IGFBP-3
- Insulin
- (and 13 more...)
|
60 |
Male |
8 Years to 8 Years (Child) |
NCT00378820 |
KF 01-072/04 D-111 |
|
July 2004 |
|
April 2005 |
September 21, 2006 |
January 21, 2009 |
|
- Institute of Human Nutrition, Rolighedsvej 30
Frederiksberg C, Denmark
|
29 |
NCT01361165 |
Completed |
Data Analysis for 04-C-0234 Tenofovir Disoproxil Fumarate Salvage Therapy in HIV-Infected Children and a Study of Its Effect on Bone Metabolism |
|
|
Observational |
|
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
10 |
|
Child, Adult, Senior |
NCT01361165 |
999906255 06-C-N255 |
|
September 2006 |
|
October 2008 |
May 26, 2011 |
May 26, 2011 |
|
- National Cancer Institute (NCI)
Bethesda, Maryland, United States
|
30 |
NCT02821559 |
Completed |
Biweekly Versus Triweekly Raltitrexed With Oxaliplatin (With or Without Bevacizumab) in First-line Metastatic Colorectal Cancer |
- Metastatic Colorectal Cancer
|
- Drug: TOMOX
- Drug: Bevacizumab
|
Interventional |
Phase 2 |
- Centre Hospitalier Universitaire de Besancon
- Hospira, now a wholly owned subsidiary of Pfizer
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Evolution of Raltitrexed plasma levels
- treatment-related adverse events as assessed by CTCAE v4.0
- objective response rate evaluated by RECIST 1.1 criteria
- (and 2 more...)
|
37 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02821559 |
EROS 2011-005811-96 |
EROS |
July 2012 |
August 2014 |
|
July 1, 2016 |
July 1, 2016 |
|
- CHRU de Besançon
Besançon, France
|
31 |
NCT00874328 |
Unknown † |
A Study of TS-1 Plus Irinotecan and Cisplatin (IP) for Patients With Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC) |
- Advanced Non-Small Cell Lung Cancer
|
- Drug: Irinotecan
- Drug: Cisplatin
- Drug: TS-1 (S-1)
|
Interventional |
Phase 1 Phase 2 |
- National Cancer Center, Korea
- Jeil Pharmaceutical Co., Ltd.
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Evaluation the Response rate IP plus TS-1(in phase 2)
- To estimate the time to progression and overall survival
- Determine MTD (Maximum tolerated dose) in phase I
|
74 |
All |
18 Years and older (Adult, Senior) |
NCT00874328 |
NCCCTS-08-333 |
|
October 2008 |
December 2011 |
December 2012 |
April 2, 2009 |
October 25, 2010 |
|
- Asan Medical Center
Seoul, Korea, Republic of
|
32 |
NCT00059930 |
Active, not recruiting |
Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer |
- Colorectal Cancer
- Metastatic Cancer
|
- Drug: FOLFOX regimen
- Drug: dexamethasone
- Drug: floxuridine
- (and 5 more...)
|
Interventional |
Phase 1 |
- Memorial Sloan Kettering Cancer Center
- National Cancer Institute (NCI)
- University of Medicine and Dentistry of New Jersey
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose
- Correlate thymidylate synthase, dihydropyrimidine dehydrogenase, and ERCC-1 with survival and recurrence as measured by normal and tumor liver tissue
|
38 |
All |
18 Years and older (Adult, Senior) |
NCT00059930 |
03-005 MSKCC-03005 |
|
January 2003 |
June 2018 |
June 2018 |
May 7, 2003 |
July 6, 2017 |
|
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States - Memorial Sloan Kettering Cancer Center
New York, New York, United States
|
33 |
NCT02763280 |
Completed |
Efficacy and Safety of Ginseng Extract on Improvement of Bone Metabolism in Menopausal Women |
|
- Dietary Supplement: Ginseng extract 1g
- Dietary Supplement: Ginseng extract 3g
- Dietary Supplement: Placebo
|
Interventional |
Not Applicable |
- Chonbuk National University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Changes in Serum Osteocalcin
- Changes in Urinary Deoxypyridinoline
- Changes in DPD/OC ratio
- (and 6 more...)
|
90 |
Female |
40 Years and older (Adult, Senior) |
NCT02763280 |
RDA-BM-GE |
|
June 2015 |
July 2015 |
September 2016 |
May 5, 2016 |
February 5, 2018 |
|
- Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of
|
34 |
NCT02297126 |
Recruiting |
A Prospective Trial to Assess Cost and Clinical Outcomes of a Clinical Pharmacogenomic Program |
|
- Device: Pharmacogenetic Intervention Arm (pharmacogenetic testing)
|
Interventional |
Not Applicable |
- Indiana University
- National Human Genome Research Institute (NHGRI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Financial impact on the total cost of patient care resulting from implementation of a Pharmacogenetics testing program within a safety-net and Academic healthcare system
- Impact of implementing a Pharmacogenetics program on Clinical Outcomes (incidence and severity of adverse events, frequency of healthcare visits, length of hospital stay, and readmissions) within a safety-net and Academic healthcare system
- Impact of implementing a Pharmacogenetics program on prescribing patterns within a safety-net healthcare system
|
6000 |
All |
18 Years and older (Adult, Senior) |
NCT02297126 |
1401206188 U01HG007762-01 |
INGenious |
January 2015 |
June 2018 |
June 2018 |
November 21, 2014 |
November 20, 2017 |
|
- Eskenazi Health System
Indianapolis, Indiana, United States
|
35 |
NCT01272830 |
Completed Has Results |
Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements |
- Edematous
- Synovitis
- Foreign Body Reaction
- Osteolysis
|
- Drug: Placebo
- Drug: Apatone®B
|
Interventional |
Phase 2 |
- IC-MedTech Corporation
- Summa Health System
- Crystal Clinic Orthopaedic Center LLC
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Pain Visual Analog Scale (VAS)
- Surrogate Endpoint Markers (SEBs)
- TGFBeta Levels
- Deoxypyridinoline Levels
|
57 |
All |
50 Years to 85 Years (Adult, Senior) |
NCT01272830 |
Summa-09136 |
Apatone-B |
October 2010 |
December 2014 |
December 2015 |
January 10, 2011 |
January 31, 2018 |
January 31, 2018 |
- Summa Health System
Akron, Ohio, United States
|
36 |
NCT00001579 |
Completed |
A Phase I Trial of 5-Fluorouracil Given With 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients With Solid Tumors |
|
- Drug: 5-Fluorouracil
- Drug: Ethynyluracil
- Drug: Leucovorin
|
Interventional |
Phase 1 |
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Primary Purpose: Treatment
|
|
50 |
All |
Child, Adult, Senior |
NCT00001579 |
970136 97-C-0136 |
|
June 1997 |
|
March 2001 |
December 10, 2002 |
July 17, 2006 |
|
- National Cancer Institute (NCI)
Bethesda, Maryland, United States
|
37 |
NCT00170911 |
Completed |
Efficacy and Safety of AAE581 in Postmenopausal Women With Osteopenia/Osteoporosis. |
|
|
Interventional |
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Change of lumbar spine(L1-L4)BMD at 12 months
- Safety of 12 month treatment
- Change of BMD of lumbar spine(L1-L4,L2-L4)、total hip, femoral neck, forearm and total body at 3, 6, 9 and 12 months
- (and 2 more...)
|
160 |
Female |
50 Years to 75 Years (Adult, Senior) |
NCT00170911 |
CAAE581A1201 |
|
March 2005 |
December 2005 |
|
September 15, 2005 |
November 2, 2011 |
|
|
38 |
NCT02315248 |
Completed |
Salivary-based Bone Loss Marker Detection Platform for Point-of-care Screening - Phase II Study |
|
- Radiation: Quantitative computed tomography scan for bone density analysis
|
Observational |
|
- University of Mississippi Medical Center
- National Institute of Dental and Craniofacial Research (NIDCR)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Validation of human saliva sample analyzer LFA technique against measured bone density
- Validation of human saliva sample analyzer LFA technique against ELISA (gold standard)
|
197 |
Female |
50 Years and older (Adult, Senior) |
NCT02315248 |
2014-0108 |
|
December 2014 |
August 2016 |
August 2016 |
December 11, 2014 |
February 9, 2017 |
|
- University of Mississippi Medical Center
Jackson, Mississippi, United States
|
39 |
NCT01250314 |
Completed |
Radiological Biological Genetic and Micro-architectural Bone Determinants of Fractures in Men With Low Bone Mineral Density |
|
- Other: Radiology
- Other: Biological, biochemical and genetic samples
|
Interventional |
Not Applicable |
- Assistance Publique - Hôpitaux de Paris
- Ministry of Health, France
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
|
- Biochemical
- Genetic
- Radiological
|
79 |
Male |
40 Years to 70 Years (Adult, Senior) |
NCT01250314 |
P070121 |
OSTEHOM |
February 2008 |
September 2010 |
December 2010 |
November 30, 2010 |
July 3, 2012 |
|
- Fédération de Rhumatologie - Hôpital LARIBOISIERE
Paris, France
|
40 |
NCT01066858 |
Completed |
Study of Effects of Tenofovir on Bone Health and Kidneys During Pregnancy and Breastfeeding |
|
- Drug: Tenofovir disoproxil fumarate (TDF)
|
Observational |
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Gilead Sciences
|
NIH / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Antepartum Component: Creatinine clearance (CrCl)
- Antepartum Component: Bone resorption (Dpyr)
- Antepartum Component: Lumbar spine bone mineral density (BMD) via dual energy e-ray absorptiometry (DXA)
- (and 14 more...)
|
1765 |
All |
Child, Adult, Senior |
NCT01066858 |
P1084s (PROMISE) 10790 IMPAACT P1084s |
|
March 2011 |
November 2015 |
November 2015 |
February 10, 2010 |
January 14, 2016 |
|
- Blantyre CRS
Blantyre, Malawi - Malawi CRS
Lilongwe, Malawi - Soweto IMPAACT CRS
Johannesburg, Gauteng, South Africa - (and 8 more...)
|
41 |
NCT00169000 |
Completed |
Safety Study of a New Schedule of Capecitabine and Docetaxel to Treat Cancers |
|
- Drug: Capecitabine
- Drug: Docetaxel
|
Interventional |
Phase 1 |
- Dartmouth-Hitchcock Medical Center
- Hoffmann-La Roche
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To determine the maximum tolerated dose, and dose limiting toxicity of capecitabine when given daily for 14 days with docetaxel given on day 8 of a 21 day cycle
- To determine the pharmacokinetic profile of capecitabine, 5-fluorouracil, and 5'-deoxy-5-fluorouridine following administration of docetaxel on day 8.
- To determine the expression of Bax, Bcl-2, and phosphorylated Bcl-2 at baseline and again on days 8 and 9 of capecitabine when given at the MTD
- To define pharmacodynamic relationships between observed changes in dihydropyrimidine dehydrogenase (DPD) and altered expression of Bax and Bcl-2 with clinical toxicities and antitumor response
|
12 |
All |
18 Years and older (Adult, Senior) |
NCT00169000 |
D-0139 |
|
January 2003 |
September 2005 |
March 2006 |
September 15, 2005 |
August 6, 2009 |
|
- Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
|
42 |
NCT01472822 |
Completed Has Results |
Efficacy of Omija (Schisandra Chinensis) Extract in Subjects With Knee Osteoarthritis |
|
- Dietary Supplement: Omija extract.
- Dietary Supplement: Placebo
|
Interventional |
Phase 2 Phase 3 |
- Chonbuk National University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score
- Changes in Lysholm Index Score
- Changes in Hs-CRP(High Sensitivity C-reactive Protein)
- (and 2 more...)
|
60 |
All |
30 Years to 70 Years (Adult, Senior) |
NCT01472822 |
BIOYD-KA-SCHISANDRA |
|
March 2011 |
June 2011 |
December 2011 |
November 17, 2011 |
February 4, 2013 |
February 4, 2013 |
- Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of
|
43 |
NCT00333229 |
Terminated Has Results |
A Study of Zoledronic Acid in the Prevention of Cancer Therapy-induced Bone Loss |
- Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women
|
- Drug: Zoledronic Acid
- Drug: Placebo
|
Interventional |
Phase 4 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Bone Mineral Density (BMD) Measured by DXA at Lumbar Spine (L2-L4) Between Baseline and 24 Months.
- Bone Mineral Density (BMD) Measured by QUS at os Calcis and Phalanges After 24 Months
- Course of Biochemical Markers of Bone Turn Over (FSH, Estradiol (E2), Osteocalcin, PINP, Procollagene-I-peptid, Deoxypyridinoline in Serum)
- (and 2 more...)
|
11 |
Female |
18 Years and older (Adult, Senior) |
NCT00333229 |
CZOL446GDE13 2004-002831-14 |
|
March 2006 |
December 2013 |
December 2013 |
June 2, 2006 |
November 25, 2014 |
November 25, 2014 |
- Novartis Investigative Site
Marburg, Germany
|
44 |
NCT03051867 |
Completed |
Vitamin D Status and Metabolism in Human Pregnancy |
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Maternal circulating concentrations of 25-hydroxyvitamin D
- Maternal circulating concentrations of 1,25-dihydroxyvitamin D
- Maternal circulating concentrations 24,25-dihydroxyvitamin D
- (and 8 more...)
|
47 |
Female |
21 Years and older (Adult, Senior) |
NCT03051867 |
OSP 74161 |
|
January 15, 2009 |
December 18, 2010 |
December 18, 2011 |
February 14, 2017 |
February 14, 2017 |
|
- Human Metabolic Research Unit, Cornell University
Ithaca, New York, United States
|
45 |
NCT01645748 |
Completed |
Docetaxel, Cisplatin, and S-1 (TPS) Induction Chemotherapy in Locally Advanced Head and Neck Cancer |
|
|
Interventional |
Phase 2 |
- Chonnam National University Hospital
- Chungbuk National University
- Chonbuk National University
- Chungnam National University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Response rate
- Safety
- Progression free survival
- Overall survival
|
35 |
All |
18 Years and older (Adult, Senior) |
NCT01645748 |
CNUHH-MO-02 CNUHH |
TPSHNSCC |
October 2008 |
October 2011 |
March 2012 |
July 20, 2012 |
July 20, 2012 |
|
- Chonnam National University Hwasun Hospital
Gwangju, Jeollanamdo, Korea, Republic of
|
46 |
NCT01220050 |
Completed |
Paricalcitol in Reducing Parathyroid Hormone Levels and Ameliorating Markers of Bone Remodelling in Renal Transplant Recipients With Secondary Hyperparathyroidism |
- Renal Transplant
- Secondary Hyperparathyroidism
|
- Drug: Paricalcitol
- Drug: Standard therapy
|
Interventional |
Phase 2 |
- Mario Negri Institute for Pharmacological Research
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- PTH reduction during the 6 months of paricalcitol therapy (during both treatment periods) compared to the change in PTH levels during the corresponding 6 months without paricalcitol therapy.
- Measurement of osteocalcin.
- Measurement of bone alkaline phosphatase.
- (and 2 more...)
|
43 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT01220050 |
APPLE 2008-006380-36 |
APPLE |
September 2009 |
July 2012 |
February 2013 |
October 13, 2010 |
February 22, 2013 |
|
- Mario Negri Institute - Clinical Research Center for Rare Diseases
Ranica, Bergamo, Italy
|
47 |
NCT01799798 |
Completed |
Translational Therapy in Patients With Osteogenesis Imperfecta - A Pilot Trial on Treatment With the Rankl-Antibody Denosumab |
|
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Changes of bone mineral density (BMD [g/cm2]) in lumbar spine after 36 weeks of treatment with denosumab. Changes will be calculated between baseline and study week 48.
- Decrease of osteoclastic activity measured by urinary deoxypyridinoline (DPD).
- Parathormone in study week 12, 24, 36 and 48 compared to baseline.
- (and 2 more...)
|
10 |
All |
5 Years to 11 Years (Child) |
NCT01799798 |
Uni-Koeln-1574 |
OI-AK |
February 2013 |
January 2015 |
January 2015 |
February 27, 2013 |
January 27, 2015 |
|
- University Cologne, Childrens Hospital, Cologne, Germany
Cologne, NRW, Germany
|
48 |
NCT00216021 |
Completed |
Capecitabine and Oxaliplatin in Treating Patients With Metastatic Breast Cancer |
|
- Drug: Capecitabine
- Drug: Oxaliplatin
|
Interventional |
Phase 2 |
- Hoosier Cancer Research Network
- Sanofi
- Hoffmann-La Roche
- Walther Cancer Institute
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- - To determine the objective response rate (CR+PR) of capecitabine and oxaliplatin (CAPOX) in patients with metastatic breast cancer.
- To measure time to progression ·
- To determine rate of clinical benefit response (CR + PR + SD > 6 months). ·
- (and 2 more...)
|
25 |
Female |
18 Years and older (Adult, Senior) |
NCT00216021 |
HOG BRE03-60 |
|
March 2004 |
June 2007 |
June 2007 |
September 22, 2005 |
December 9, 2015 |
|
- Helen F. Graham Cancer Center
Newark, Delaware, United States - Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States - Elkhart Clinic
Elkhart, Indiana, United States - (and 8 more...)
|
49 |
NCT00112437 |
Completed Has Results |
A Study to Examine the Effects of an Experimental Drug on Postmenopausal Osteoporosis (MK-0822-004) |
|
- Drug: Odanacatib
- Dietary Supplement: Vitamin D3
- Dietary Supplement: Calcium Carbonate
- Drug: Placebo
|
Interventional |
Phase 2 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months
- Percentage Change From Baseline in Lumbar Spine BMD at 24 Months
- Percentage Change From Baseline in Lumbar Spine BMD at 36 Months
- (and 36 more...)
|
399 |
Female |
45 Years to 85 Years (Adult, Senior) |
NCT00112437 |
0822-004 2005_023 |
|
June 24, 2005 |
December 26, 2007 |
January 20, 2016 |
June 3, 2005 |
January 24, 2018 |
May 13, 2010 |
|
50 |
NCT00258284 |
Completed |
Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer |
|
- Drug: capecitabine
- Drug: docetaxel
|
Interventional |
Phase 2 |
- Barbara Ann Karmanos Cancer Institute
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Response rate by RECIST criteria after every 2 courses
- Toxicity at 30 days after last treatment
- Progression-free survival
- (and 3 more...)
|
30 |
Male |
18 Years and older (Adult, Senior) |
NCT00258284 |
CDR0000445613 P30CA022453 WSU-D-2615 WSU-HIC-067903MP4F |
|
August 2003 |
November 2007 |
November 2007 |
November 24, 2005 |
March 6, 2014 |
|
- Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
|