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

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ClinicalTrials.gov Identifier: NCT00671788
Recruitment Status : Completed
First Posted : May 5, 2008
Results First Posted : July 18, 2014
Last Update Posted : April 15, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Interventions: Drug: Dasatinib
Other: Laboratory Biomarker Analysis

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was activated on 6/2/2008 and closed to accrual on 4/12/2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Dasatinib
STARTED   35 
COMPLETED   21 [1] 
NOT COMPLETED   14 
Adverse Event                8 
Refused further treatment                3 
Ineligible                1 
MD Decision                1 
Other                1 
[1] Patients treated until disease progression; completed defined as off treatment due to progression.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Eligible and treated participants

Reporting Groups
  Description
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

Baseline Measures
   Dasatinib 
Overall Participants Analyzed 
[Units: Participants]
 34 
Age, Customized 
[Units: Participants]
 
40-49 years   4 
50-59 years   9 
60-69 years   13 
70-79 years   6 
80-89 years   2 
Gender 
[Units: Participants]
 
Female   34 
Male   0 


  Outcome Measures

1.  Primary:   Progression-free Survival at 6 Months   [ Time Frame: 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. ]

2.  Primary:   Tumor Response   [ Time Frame: 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. ]

3.  Secondary:   Progression-free Survival   [ Time Frame: 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. ]

4.  Secondary:   Overall Survival   [ Time Frame: Every other cycle up to 5 years ]

5.  Secondary:   Frequency and Severity of Adverse Events as Assessed by CTCAE v3.0   [ Time Frame: Every cycle during treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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:  
Name/Title: Jessalyn Reboy
Organization: Gynecologic Oncology Group Statistical and Data Center
phone: 716-845-7738
e-mail: reboyj@nrgoncology.org



Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00671788     History of Changes
Other Study ID Numbers: GOG-0170M
NCI-2011-03824 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000594930
GOG-0170M ( Other Identifier: Gynecologic Oncology Group )
GOG-0170M ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: May 2, 2008
First Posted: May 5, 2008
Results First Submitted: January 31, 2014
Results First Posted: July 18, 2014
Last Update Posted: April 15, 2016