Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dasatinib in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, Endometrial or Peritoneal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02059265
Recruitment Status : Active, not recruiting
First Posted : February 11, 2014
Results First Posted : May 17, 2019
Last Update Posted : October 22, 2019
Sponsor:
Collaborator:
NRG Oncology
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Endometrial Clear Cell Adenocarcinoma
Ovarian Clear Cell Cystadenocarcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Recurrent Uterine Corpus Carcinoma
Interventions Drug: Dasatinib
Other: Laboratory Biomarker Analysis
Enrollment 35
Recruitment Details The study opened on 2/3/2014 and accrued 35 (28 treated and eligible) of a planned 62 patients. The study was closed on 8/10/2016, after evaluation of the stage 1 data.
Pre-assignment Details Four patients were deemed ineligible and three patients were never treated; 28 patients were evaluable for efficacy and safety.
Arm/Group Title Treatment (Dasatinib)
Hide Arm/Group Description

Patients receive dasatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Dasatinib: Given PO

Laboratory Biomarker Analysis: Correlative studies

Period Title: Overall Study
Started 32
Completed 28
Not Completed 4
Reason Not Completed
Ineligible             4
Arm/Group Title Dasatinib
Hide Arm/Group Description Dasatinib – 140 mg by mouth, once daily, on days 1-28 (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
20-29 years
0
   0.0%
30-39 years
2
   7.1%
40-49 years
3
  10.7%
50-59 years
10
  35.7%
60-69 years
8
  28.6%
70-79 years
4
  14.3%
>= 80 years
1
   3.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
28
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
28
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
  10.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   7.1%
White
23
  82.1%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1
Hide Description Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Time Frame CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter until disease progression for up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Dasatinib)
Hide Arm/Group Description:

Patients receive dasatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Dasatinib: Given PO

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 28
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.6%
2.Secondary Outcome
Title Duration of Overall Survival (OS)
Hide Description Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Time Frame Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Dasatinib)
Hide Arm/Group Description:

Patients receive dasatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Dasatinib: Given PO

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 28
Median (95% Confidence Interval)
Unit of Measure: Months
16.92
(4.57 to 30.52)
3.Secondary Outcome
Title Duration of Progression-free Survival (PFS)
Hide Description PFS will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.
Time Frame Duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Dasatinib)
Hide Arm/Group Description:

Patients receive dasatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Dasatinib: Given PO

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 28
Median (95% Confidence Interval)
Unit of Measure: Months
2.14
(1.58 to 7.29)
4.Secondary Outcome
Title Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0
Hide Description The frequency and severity of all toxicities are tabulated.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Dasatinib)
Hide Arm/Group Description:

Patients receive dasatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Dasatinib: Given PO

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: Count of Participants with >= grade 3 AE
20
5.Other Pre-specified Outcome
Title ARID1A Mutation Status in Formalin-fixed, Paraffin Embedded Tissue Using Next-generation Exon-capture Sequencing
Hide Description ARID1A mutation status will be tabulated to determine the correlation between BAF250a IHC and ARID1A mutations.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
ARID1A information was available for 26 of 35 patients. Missing data is attributed to assay failure.
Arm/Group Title Treatment (Dasatinib)
Hide Arm/Group Description:

Patients receive dasatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Dasatinib: Given PO

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Spearman Correlation Coefficient
0.82
(0.59 to 1.00)
Time Frame Up to 5 Years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Dasatinib)
Hide Arm/Group Description

Patients receive dasatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Dasatinib: Given PO

Laboratory Biomarker Analysis: Correlative studies

All-Cause Mortality
Treatment (Dasatinib)
Affected / at Risk (%)
Total   24/28 (85.71%) 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Dasatinib)
Affected / at Risk (%)
Total   16/28 (57.14%) 
Cardiac disorders   
Cardiac Arrest * 1  1/28 (3.57%) 
Pericardial Effusion * 1  1/28 (3.57%) 
Gastrointestinal disorders   
Duodenal Obstruction * 1  1/28 (3.57%) 
Vomiting * 1  1/28 (3.57%) 
Stomach Pain * 1  1/28 (3.57%) 
Abdominal Pain * 1  2/28 (7.14%) 
Lower Gastrointestinal Hemorrhage * 1  1/28 (3.57%) 
Gastrointestinal Pain * 1  1/28 (3.57%) 
Infections and infestations   
Lung Infection * 1  1/28 (3.57%) 
Musculoskeletal and connective tissue disorders   
Generalized Muscle Weakness * 1  1/28 (3.57%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms Benign, Malignant And Unspecified (Incl * 1  1/28 (3.57%) 
Nervous system disorders   
Syncope * 1  1/28 (3.57%) 
Psychiatric disorders   
Confusion * 1  1/28 (3.57%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  2/28 (7.14%) 
Vascular disorders   
Thromboembolic Event * 1  1/28 (3.57%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Dasatinib)
Affected / at Risk (%)
Total   28/28 (100.00%) 
Blood and lymphatic system disorders   
Anemia * 1  21/28 (75.00%) 
Cardiac disorders   
Atrial Fibrillation * 1  1/28 (3.57%) 
Cardiac Arrest * 1  1/28 (3.57%) 
Palpitations * 1  1/28 (3.57%) 
Sinus Tachycardia * 1  1/28 (3.57%) 
Endocrine disorders   
Hypothyroidism * 1  1/28 (3.57%) 
Gastrointestinal disorders   
Dyspepsia * 1  1/28 (3.57%) 
Duodenal Obstruction * 1  1/28 (3.57%) 
Dry Mouth * 1  1/28 (3.57%) 
Constipation * 1  8/28 (28.57%) 
Diarrhea * 1  12/28 (42.86%) 
Vomiting * 1  7/28 (25.00%) 
Bloating * 1  3/28 (10.71%) 
Stomach Pain * 1  1/28 (3.57%) 
Anal Hemorrhage * 1  1/28 (3.57%) 
Abdominal Pain * 1  11/28 (39.29%) 
Mucositis Oral * 1  1/28 (3.57%) 
Gastrointestinal Pain * 1  1/28 (3.57%) 
Gastric Hemorrhage * 1  1/28 (3.57%) 
Abdominal Distension * 1  2/28 (7.14%) 
Nausea * 1  19/28 (67.86%) 
Gastroesophageal Reflux Disease * 1  1/28 (3.57%) 
Hemorrhoids * 1  2/28 (7.14%) 
Ascites * 1  1/28 (3.57%) 
Jejunal Obstruction * 1  1/28 (3.57%) 
Flatulence * 1  2/28 (7.14%) 
General disorders   
Pain * 1  1/28 (3.57%) 
Flu Like Symptoms * 1  1/28 (3.57%) 
Non-Cardiac Chest Pain * 1  1/28 (3.57%) 
Edema Limbs * 1  3/28 (10.71%) 
Fatigue * 1  20/28 (71.43%) 
Fever * 1  5/28 (17.86%) 
Infections and infestations   
Sinusitis * 1  1/28 (3.57%) 
Lung Infection * 1  2/28 (7.14%) 
Urinary Tract Infection * 1  2/28 (7.14%) 
Abdominal Infection * 1  1/28 (3.57%) 
Injury, poisoning and procedural complications   
Bruising * 1  1/28 (3.57%) 
Investigations   
Weight Loss * 1  1/28 (3.57%) 
Weight Gain * 1  1/28 (3.57%) 
Platelet Count Decreased * 1  3/28 (10.71%) 
Electrocardiogram Qt Corrected Interval Prolonged * 1  2/28 (7.14%) 
Creatinine Increased * 1  7/28 (25.00%) 
Neutrophil Count Decreased * 1  3/28 (10.71%) 
Blood Bilirubin Increased * 1  1/28 (3.57%) 
White Blood Cell Decreased * 1  6/28 (21.43%) 
Aspartate Aminotransferase Increased * 1  1/28 (3.57%) 
Alkaline Phosphatase Increased * 1  5/28 (17.86%) 
Alanine Aminotransferase Increased * 1  1/28 (3.57%) 
Metabolism and nutrition disorders   
Hypophosphatemia * 1  3/28 (10.71%) 
Hyponatremia * 1  3/28 (10.71%) 
Hypomagnesemia * 1  1/28 (3.57%) 
Hypokalemia * 1  2/28 (7.14%) 
Hypocalcemia * 1  2/28 (7.14%) 
Hypoalbuminemia * 1  5/28 (17.86%) 
Hypernatremia * 1  1/28 (3.57%) 
Hypermagnesemia * 1  2/28 (7.14%) 
Hyperkalemia * 1  1/28 (3.57%) 
Hyperglycemia * 1  3/28 (10.71%) 
Hypercalcemia * 1  1/28 (3.57%) 
Dehydration * 1  2/28 (7.14%) 
Anorexia * 1  7/28 (25.00%) 
Musculoskeletal and connective tissue disorders   
Pain In Extremity * 1  3/28 (10.71%) 
Neck Pain * 1  1/28 (3.57%) 
Myalgia * 1  5/28 (17.86%) 
Generalized Muscle Weakness * 1  7/28 (25.00%) 
Back Pain * 1  4/28 (14.29%) 
Arthralgia * 1  2/28 (7.14%) 
Nervous system disorders   
Tremor * 1  2/28 (7.14%) 
Peripheral Sensory Neuropathy * 1  8/28 (28.57%) 
Paresthesia * 1  2/28 (7.14%) 
Headache * 1  5/28 (17.86%) 
Dysgeusia * 1  1/28 (3.57%) 
Syncope * 1  1/28 (3.57%) 
Dizziness * 1  1/28 (3.57%) 
Cognitive Disturbance * 1  1/28 (3.57%) 
Psychiatric disorders   
Insomnia * 1  1/28 (3.57%) 
Depression * 1  2/28 (7.14%) 
Confusion * 1  1/28 (3.57%) 
Anxiety * 1  4/28 (14.29%) 
Renal and urinary disorders   
Urinary Urgency * 1  1/28 (3.57%) 
Hematuria * 1  2/28 (7.14%) 
Chronic Kidney Disease * 1  1/28 (3.57%) 
Reproductive system and breast disorders   
Breast Pain * 1  1/28 (3.57%) 
Respiratory, thoracic and mediastinal disorders   
Postnasal Drip * 1  1/28 (3.57%) 
Pleural Effusion * 1  6/28 (21.43%) 
Dyspnea * 1  6/28 (21.43%) 
Cough * 1  8/28 (28.57%) 
Skin and subcutaneous tissue disorders   
Periorbital Edema * 1  1/28 (3.57%) 
Palmar-Plantar Erythrodysesthesia Syndrome * 1  1/28 (3.57%) 
Rash Maculo-Papular * 1  1/28 (3.57%) 
Erythema Multiforme * 1  1/28 (3.57%) 
Dry Skin * 1  1/28 (3.57%) 
Alopecia * 1  2/28 (7.14%) 
Vascular disorders   
Thromboembolic Event * 1  2/28 (7.14%) 
Lymphedema * 1  1/28 (3.57%) 
Hypotension * 1  1/28 (3.57%) 
Hypertension * 1  3/28 (10.71%) 
Hot Flashes * 1  3/28 (10.71%) 
Flushing * 1  2/28 (7.14%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christopher Purdy on behalf of Austin Miller
Organization: NRG Oncology
Phone: (716)845-1300 ext 2296
EMail: purdyc@nrgoncology.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02059265     History of Changes
Other Study ID Numbers: NCI-2014-00209
NCI-2014-00209 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0283
GOG-0283 ( Other Identifier: NRG Oncology )
GOG-0283 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: February 7, 2014
First Posted: February 11, 2014
Results First Submitted: April 24, 2019
Results First Posted: May 17, 2019
Last Update Posted: October 22, 2019