Trial Outcomes & Findings for Gleevec Study for Patients With Ovarian Cancer (NCT NCT00510653)

Results Overview

ORR = participant proportion with responsive disease: Complete Response (CR): disappearance all clinically detectable malignant disease for at least 4 weeks, no new lesions; Partial Response (PR): \>/= 50% decrease sum of products of perpendicular diameters of all measurable lesions for at least 4 weeks; Stable Disease: does not qualify for CR, PR or progression. Progressive Disease: a 25% or \> increase in sum of products of measurable lesions over smallest sum observed, OR reappearance of lesion which had disappeared, OR appearance of new lesion/site. Response determined every 6 week cycle.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

73 participants

Primary outcome timeframe

6 weeks with re-evaluation every 6 weeks or until disease progression

Results posted on

2013-08-23

Participant Flow

Recruitment Period: March 7, 2002 to September 30, 2009. All registration was done at The University of Texas (UT) MD Anderson Cancer Center.

Of the 73 enrolled, 27 were excluded as not eligible and one inevaluable for the study. Another four (4) participants were found to be not eligible following screening.

Participant milestones

Participant milestones
Measure	Imatinib Mesylate 600 mg/day orally for 6 Weeks
Overall Study STARTED	24
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Imatinib Mesylate 600 mg/day orally for 6 Weeks
Overall Study Withdrawal by Subject	8
Overall Study Monetary	3

Baseline Characteristics

Gleevec Study for Patients With Ovarian Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Imatinib Mesylate n=24 Participants 600 mg/day orally for 6 Weeks
Age Continuous	52 years n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks with re-evaluation every 6 weeks or until disease progression

Population: Two participants were not evaluable for response: in 1 participant, early toxicity caused discontinuation of the drug, and the other patient had an intestinal obstruction requiring palliative surgery after 1 day of therapy.

ORR = participant proportion with responsive disease: Complete Response (CR): disappearance all clinically detectable malignant disease for at least 4 weeks, no new lesions; Partial Response (PR): \>/= 50% decrease sum of products of perpendicular diameters of all measurable lesions for at least 4 weeks; Stable Disease: does not qualify for CR, PR or progression. Progressive Disease: a 25% or \> increase in sum of products of measurable lesions over smallest sum observed, OR reappearance of lesion which had disappeared, OR appearance of new lesion/site. Response determined every 6 week cycle.

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=11 Participants 600 mg/day orally for 6 Weeks
Overall Response Rate (ORR) Complete Response	0 participants
Overall Response Rate (ORR) Partial Response	0 participants

Adverse Events

Imatinib Mesylate

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Imatinib Mesylate n=13 participants at risk 600 mg/day orally for 6 Weeks
Blood and lymphatic system disorders Granulocytopenia	7.7% 1/13 • 7 years
Blood and lymphatic system disorders Anemia	23.1% 3/13 • 7 years
Skin and subcutaneous tissue disorders Rash	7.7% 1/13 • 7 years
Infections and infestations Febrile neutropenia	7.7% 1/13 • 7 years

Other adverse events

Other adverse events
Measure	Imatinib Mesylate n=13 participants at risk 600 mg/day orally for 6 Weeks
General disorders Fatigue	61.5% 8/13 • 7 years
Gastrointestinal disorders Nausea-vomiting	61.5% 8/13 • 7 years
Vascular disorders Edema	38.5% 5/13 • 7 years
Nervous system disorders Neuropathy (sensory)	23.1% 3/13 • 7 years
Skin and subcutaneous tissue disorders Rash	7.7% 1/13 • 7 years
Gastrointestinal disorders Diarrhea	38.5% 5/13 • 7 years
Gastrointestinal disorders Weight Gain	15.4% 2/13 • 7 years

Additional Information

David Gershenson, MD / Professor

The University of Texas (UT) MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place