Trial Outcomes & Findings for Dasatinib in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, Endometrial or Peritoneal Cancer (NCT NCT02059265)
NCT ID: NCT02059265
Last Updated: 2023-08-01
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
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.
Results posted on
2023-08-01
Participant Flow
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.
Four patients were deemed ineligible and three patients were never treated; 28 patients were evaluable for efficacy and safety.
Participant milestones
| Measure |
Treatment (Dasatinib)
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 Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Treatment (Dasatinib)
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 Study
Ineligible
|
4
|
Baseline Characteristics
Dasatinib in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, Endometrial or Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Dasatinib
n=28 Participants
Dasatinib - 140 mg by mouth, once daily, on days 1-28 (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Age, Customized
20-29 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
2 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
3 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
10 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
8 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
4 Participants
n=5 Participants
|
|
Age, Customized
>= 80 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
Treatment (Dasatinib)
n=28 Participants
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
|
|---|---|
|
Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Outcome measures
| Measure |
Treatment (Dasatinib)
n=28 Participants
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
|
|---|---|
|
Duration of Overall Survival (OS)
|
16.92 Months
Interval 4.57 to 30.52
|
SECONDARY outcome
Timeframe: Duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 yearsPFS will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.
Outcome measures
| Measure |
Treatment (Dasatinib)
n=28 Participants
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
|
|---|---|
|
Duration of Progression-free Survival (PFS)
|
2.14 Months
Interval 1.58 to 7.29
|
SECONDARY outcome
Timeframe: Up to 5 yearsThe frequency and severity of all toxicities are tabulated.
Outcome measures
| Measure |
Treatment (Dasatinib)
n=28 Participants
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
|
|---|---|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0
|
20 Count of Participants with >= grade 3 AE
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsPopulation: ARID1A information was available for 26 of 35 patients. Missing data is attributed to assay failure.
ARID1A mutation status will be tabulated to determine the correlation between BAF250a IHC and ARID1A mutations.
Outcome measures
| Measure |
Treatment (Dasatinib)
n=26 Participants
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
|
|---|---|
|
ARID1A Mutation Status in Formalin-fixed, Paraffin Embedded Tissue Using Next-generation Exon-capture Sequencing
|
0.82 Spearman Correlation Coefficient
Interval 0.59 to 1.0
|
Adverse Events
Treatment (Dasatinib)
Serious events: 16 serious events
Other events: 28 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Treatment (Dasatinib)
n=28 participants at risk
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
|
|---|---|
|
Cardiac disorders
Cardiac Arrest
|
3.6%
1/28 • Up to 5 Years
|
|
Cardiac disorders
Pericardial Effusion
|
3.6%
1/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Duodenal Obstruction
|
3.6%
1/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
1/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Stomach Pain
|
3.6%
1/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.1%
2/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Lower Gastrointestinal Hemorrhage
|
3.6%
1/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
3.6%
1/28 • Up to 5 Years
|
|
Infections and infestations
Lung Infection
|
3.6%
1/28 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
3.6%
1/28 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl
|
3.6%
1/28 • Up to 5 Years
|
|
Nervous system disorders
Syncope
|
3.6%
1/28 • Up to 5 Years
|
|
Psychiatric disorders
Confusion
|
3.6%
1/28 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.1%
2/28 • Up to 5 Years
|
|
Vascular disorders
Thromboembolic Event
|
3.6%
1/28 • Up to 5 Years
|
Other adverse events
| Measure |
Treatment (Dasatinib)
n=28 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
75.0%
21/28 • Up to 5 Years
|
|
Cardiac disorders
Atrial Fibrillation
|
3.6%
1/28 • Up to 5 Years
|
|
Cardiac disorders
Cardiac Arrest
|
3.6%
1/28 • Up to 5 Years
|
|
Cardiac disorders
Palpitations
|
3.6%
1/28 • Up to 5 Years
|
|
Cardiac disorders
Sinus Tachycardia
|
3.6%
1/28 • Up to 5 Years
|
|
Endocrine disorders
Hypothyroidism
|
3.6%
1/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Dyspepsia
|
3.6%
1/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Duodenal Obstruction
|
3.6%
1/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Dry Mouth
|
3.6%
1/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Constipation
|
28.6%
8/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Diarrhea
|
42.9%
12/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
7/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Bloating
|
10.7%
3/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Stomach Pain
|
3.6%
1/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Anal Hemorrhage
|
3.6%
1/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Abdominal Pain
|
39.3%
11/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Mucositis Oral
|
3.6%
1/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
3.6%
1/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Gastric Hemorrhage
|
3.6%
1/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Abdominal Distension
|
7.1%
2/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Nausea
|
67.9%
19/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
3.6%
1/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Hemorrhoids
|
7.1%
2/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Ascites
|
3.6%
1/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Jejunal Obstruction
|
3.6%
1/28 • Up to 5 Years
|
|
Gastrointestinal disorders
Flatulence
|
7.1%
2/28 • Up to 5 Years
|
|
General disorders
Pain
|
3.6%
1/28 • Up to 5 Years
|
|
General disorders
Flu Like Symptoms
|
3.6%
1/28 • Up to 5 Years
|
|
General disorders
Non-Cardiac Chest Pain
|
3.6%
1/28 • Up to 5 Years
|
|
General disorders
Edema Limbs
|
10.7%
3/28 • Up to 5 Years
|
|
General disorders
Fatigue
|
71.4%
20/28 • Up to 5 Years
|
|
General disorders
Fever
|
17.9%
5/28 • Up to 5 Years
|
|
Infections and infestations
Sinusitis
|
3.6%
1/28 • Up to 5 Years
|
|
Infections and infestations
Lung Infection
|
7.1%
2/28 • Up to 5 Years
|
|
Infections and infestations
Urinary Tract Infection
|
7.1%
2/28 • Up to 5 Years
|
|
Infections and infestations
Abdominal Infection
|
3.6%
1/28 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
Bruising
|
3.6%
1/28 • Up to 5 Years
|
|
Investigations
Weight Loss
|
3.6%
1/28 • Up to 5 Years
|
|
Investigations
Weight Gain
|
3.6%
1/28 • Up to 5 Years
|
|
Investigations
Platelet Count Decreased
|
10.7%
3/28 • Up to 5 Years
|
|
Investigations
Electrocardiogram Qt Corrected Interval Prolonged
|
7.1%
2/28 • Up to 5 Years
|
|
Investigations
Creatinine Increased
|
25.0%
7/28 • Up to 5 Years
|
|
Investigations
Neutrophil Count Decreased
|
10.7%
3/28 • Up to 5 Years
|
|
Investigations
Blood Bilirubin Increased
|
3.6%
1/28 • Up to 5 Years
|
|
Investigations
White Blood Cell Decreased
|
21.4%
6/28 • Up to 5 Years
|
|
Investigations
Aspartate Aminotransferase Increased
|
3.6%
1/28 • Up to 5 Years
|
|
Investigations
Alkaline Phosphatase Increased
|
17.9%
5/28 • Up to 5 Years
|
|
Investigations
Alanine Aminotransferase Increased
|
3.6%
1/28 • Up to 5 Years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.7%
3/28 • Up to 5 Years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.7%
3/28 • Up to 5 Years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.6%
1/28 • Up to 5 Years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.1%
2/28 • Up to 5 Years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.1%
2/28 • Up to 5 Years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
17.9%
5/28 • Up to 5 Years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.6%
1/28 • Up to 5 Years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
7.1%
2/28 • Up to 5 Years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.6%
1/28 • Up to 5 Years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.7%
3/28 • Up to 5 Years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.6%
1/28 • Up to 5 Years
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
2/28 • Up to 5 Years
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
7/28 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
10.7%
3/28 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
3.6%
1/28 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.9%
5/28 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
25.0%
7/28 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.3%
4/28 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
2/28 • Up to 5 Years
|
|
Nervous system disorders
Tremor
|
7.1%
2/28 • Up to 5 Years
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
28.6%
8/28 • Up to 5 Years
|
|
Nervous system disorders
Paresthesia
|
7.1%
2/28 • Up to 5 Years
|
|
Nervous system disorders
Headache
|
17.9%
5/28 • Up to 5 Years
|
|
Nervous system disorders
Dysgeusia
|
3.6%
1/28 • Up to 5 Years
|
|
Nervous system disorders
Syncope
|
3.6%
1/28 • Up to 5 Years
|
|
Nervous system disorders
Dizziness
|
3.6%
1/28 • Up to 5 Years
|
|
Nervous system disorders
Cognitive Disturbance
|
3.6%
1/28 • Up to 5 Years
|
|
Psychiatric disorders
Insomnia
|
3.6%
1/28 • Up to 5 Years
|
|
Psychiatric disorders
Depression
|
7.1%
2/28 • Up to 5 Years
|
|
Psychiatric disorders
Confusion
|
3.6%
1/28 • Up to 5 Years
|
|
Psychiatric disorders
Anxiety
|
14.3%
4/28 • Up to 5 Years
|
|
Renal and urinary disorders
Urinary Urgency
|
3.6%
1/28 • Up to 5 Years
|
|
Renal and urinary disorders
Hematuria
|
7.1%
2/28 • Up to 5 Years
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
3.6%
1/28 • Up to 5 Years
|
|
Reproductive system and breast disorders
Breast Pain
|
3.6%
1/28 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
3.6%
1/28 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
21.4%
6/28 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.4%
6/28 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
8/28 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
Periorbital Edema
|
3.6%
1/28 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
3.6%
1/28 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
3.6%
1/28 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
3.6%
1/28 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
3.6%
1/28 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
2/28 • Up to 5 Years
|
|
Vascular disorders
Thromboembolic Event
|
7.1%
2/28 • Up to 5 Years
|
|
Vascular disorders
Lymphedema
|
3.6%
1/28 • Up to 5 Years
|
|
Vascular disorders
Hypotension
|
3.6%
1/28 • Up to 5 Years
|
|
Vascular disorders
Hypertension
|
10.7%
3/28 • Up to 5 Years
|
|
Vascular disorders
Hot Flashes
|
10.7%
3/28 • Up to 5 Years
|
|
Vascular disorders
Flushing
|
7.1%
2/28 • Up to 5 Years
|
Additional Information
Christopher Purdy on behalf of Austin Miller
NRG Oncology
Phone: (716)845-1300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60