Trial Outcomes & Findings for A Phase II Evaluation of Dasatinib (Sprycel®, NSC #732517) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (NCT NCT00671788)

Last Updated: 2016-04-15

Results Overview

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

Scans to assess progression were done every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.

Results posted on

2016-04-15

Participant Flow

The study was activated on 6/2/2008 and closed to accrual on 4/12/2010.

Participant milestones

Participant milestones
Measure	Dasatinib Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
Overall Study STARTED	35
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Dasatinib Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
Overall Study Adverse Event	8
Overall Study Refused further treatment	3
Overall Study Ineligible	1
Overall Study MD Decision	1
Overall Study Other	1

Baseline Characteristics

A Phase II Evaluation of Dasatinib (Sprycel®, NSC #732517) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dasatinib n=34 Participants Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
Age, Customized 40-49 years	4 participants n=5 Participants
Age, Customized 50-59 years	9 participants n=5 Participants
Age, Customized 60-69 years	13 participants n=5 Participants
Age, Customized 70-79 years	6 participants n=5 Participants
Age, Customized 80-89 years	2 participants n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Scans to assess progression were done every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.

Outcome measures

Outcome measures
Measure	Dasatinib n=34 Participants Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
Progression-free Survival at 6 Months	20.6 percentage of participants Interval 10.1 to 35.2

PRIMARY outcome

Timeframe: Every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.

Population: Eligible and treated participants

Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.

Outcome measures

Outcome measures
Measure	Dasatinib n=34 Participants Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
Tumor Response	0 percentage of participants Interval 0.0 to 8.4

SECONDARY outcome

Timeframe: Every cycle during treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.

Population: Eligible and treated participants

Outcome measures

Outcome measures
Measure	Dasatinib n=34 Participants Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
Progression-free Survival	2.1 months Interval 1.9 to 3.2

SECONDARY outcome

Timeframe: Every other cycle up to 5 years

Population: Eligible and treated participants

Outcome measures

Outcome measures
Measure	Dasatinib n=34 Participants Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
Overall Survival	18.4 months Interval 12.9 to NA (not applicable): insufficient number of participants with events.

Adverse Events

Dasatinib

Serious events: 18 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dasatinib n=34 participants at risk Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
Immune system disorders Rhinitis	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Cardiac disorders Cardiac General - Other	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Weight Loss	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Distention	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Obstruction, Gi - Small Bowel Nos	14.7% 5/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Vomiting	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Anorexia	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Diarrhea	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Infections and infestations Inf Unknown Anc: Lung (Pneumonia)	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Nervous system disorders Cns Ischemia	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Nervous system disorders Neuropathy-Motor	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Pain: Abdominal Pain Nos	8.8% 3/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.

Other adverse events

Other adverse events
Measure	Dasatinib n=34 participants at risk Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
Immune system disorders Allergic Reaction/Hypersensitivity	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Immune system disorders Rhinitis	8.8% 3/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Ear and labyrinth disorders Auditory/Ear - Other	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Ear and labyrinth disorders Hearing (Without Monitoring Program)	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Blood and lymphatic system disorders Neutrophils	29.4% 10/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Blood and lymphatic system disorders Platelets	17.6% 6/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Blood and lymphatic system disorders Leukocytes	32.4% 11/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Blood and lymphatic system disorders Hemoglobin	91.2% 31/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Cardiac disorders Prolonged Qtc Interval	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Cardiac disorders S/N Arrhythmia: Atrial Fibrillation	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Cardiac disorders Pericardial Effusion	5.9% 2/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Vascular disorders Ptt	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Sweating	5.9% 2/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Weight Gain	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Fever	8.8% 3/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Weight Loss	8.8% 3/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Rigors/Chills	5.9% 2/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Fatigue	58.8% 20/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Insomnia	8.8% 3/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Skin and subcutaneous tissue disorders Hair Loss/Alopecia (Scalp Or Body)	8.8% 3/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Skin and subcutaneous tissue disorders Rash	11.8% 4/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Skin and subcutaneous tissue disorders Dry Skin	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Skin and subcutaneous tissue disorders Pruritus	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Skin and subcutaneous tissue disorders Flushing	5.9% 2/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Endocrine disorders Hot Flashes	5.9% 2/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Heartburn	17.6% 6/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Ascites	8.8% 3/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Ileus	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Distention	8.8% 3/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Taste Alteration	11.8% 4/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Obstruction, Gi - Small Bowel Nos	5.9% 2/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Mucositis (Clinical Exam) - Oral Cavity	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Vomiting	35.3% 12/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Anorexia	38.2% 13/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Dehydration	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Constipation	35.3% 12/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Nausea	47.1% 16/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Diarrhea	29.4% 10/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Vascular disorders Hemorrhage, Gu - Vagina	5.9% 2/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Vascular disorders Hemorrhage, Gi - Rectum	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Vascular disorders Hemorrhage, Cns	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Infections and infestations Inf Unknown Anc: Upper Airway Nos	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Blood and lymphatic system disorders Edema: Trunk/Genital	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Blood and lymphatic system disorders Edema: Limb	5.9% 2/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Blood and lymphatic system disorders Edema: Head And Neck	8.8% 3/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Ast	14.7% 5/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Metabolic/Laboratory - Other	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Creatinine	11.8% 4/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Hypoalbuminemia	5.9% 2/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Alt	8.8% 3/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Alkaline Phosphatase	8.8% 3/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Hyponatremia	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Hypernatremia	8.8% 3/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Hypocalcemia	14.7% 5/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Hyperglycemia	11.8% 4/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Hypokalemia	17.6% 6/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Hypercalcemia	8.8% 3/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Hypomagnesemia	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Musculoskeletal and connective tissue disorders Arthritis	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Musculoskeletal and connective tissue disorders Muscle Weakness - Whole Body/Generalized	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Nervous system disorders Mood Alteration - Depression	5.9% 2/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Nervous system disorders Mood Alteration - Anxiety	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Nervous system disorders Confusion	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Nervous system disorders Dizziness	11.8% 4/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Nervous system disorders Neuropathy-Sensory	11.8% 4/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Eye disorders Blurred Vision	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Pain: Pelvis	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Pain: Head/Headache	20.6% 7/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Pain: Extremity-Limb	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Pain: Joint	11.8% 4/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Pain: Abdominal Pain Nos	35.3% 12/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Pain: Muscle	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Respiratory, thoracic and mediastinal disorders Cough	17.6% 6/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	14.7% 5/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	35.3% 12/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Renal and urinary disorders Urinary Retention	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Renal and urinary disorders Urinary Frequency	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.
Reproductive system and breast disorders Vaginal Discharge	2.9% 1/34 • Adverse events were queried for and collected every cycle for the duration of treatment.

Additional Information

Jessalyn Reboy

Gynecologic Oncology Group Statistical and Data Center

Phone: 716-845-7738

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place