Trial Outcomes & Findings for Obatoclax for Systemic Mastocytosis (NCT NCT00918931)

Last Updated: 2011-11-04

Results Overview

Response rate is defined as number of participants with objective response divided by number of participants evaluated. Objective response is complete response and partial response where 'complete response' constitutes total elimination of a symptom or sign of the disease; 'partial response' constitutes at least 50% improvement in a symptom or sign of the disease. Objective response definitions of response evaluated following guidelines proposed by Valent et al. (International working group consensus criteria).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

3-Month Response Evaluation

Results posted on

2011-11-04

Participant Flow

Recruitment Period: 6/5/2009 through 3/18/2010. All participants recruited at UT MD Anderson Cancer Center.

Three patients were registered and all of them received treatment.

Participant milestones

Participant milestones
Measure	Obatoclax Mesylate 30 mg by vein over 3 hours Days 1-3, 14-day cycle
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Obatoclax for Systemic Mastocytosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Obatoclax Mesylate n=3 Participants 30 mg by vein over 3 hours Days 1-3, 14-day cycle
Age Continuous	75 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 3-Month Response Evaluation

Population: Analysis was per protocol.

Outcome measures

Outcome measures
Measure	Obatoclax Mesylate n=3 Participants 30 mg by vein over 3 hours Days 1-3, 14-day cycle
Response Rate	0 participants

Adverse Events

Obatoclax Mesylate

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Obatoclax Mesylate n=3 participants at risk 30 mg by vein over 3 hours Days 1-3, 14-day cycle
Gastrointestinal disorders Anorexia	66.7% 2/3 • Number of events 2 • 7 months
Nervous system disorders Ataxia	33.3% 1/3 • Number of events 3 • 7 months
Nervous system disorders Confusion	33.3% 1/3 • Number of events 3 • 7 months
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • 7 months
Nervous system disorders Dizziness	33.3% 1/3 • Number of events 1 • 7 months
General disorders Fatigue	66.7% 2/3 • Number of events 5 • 7 months
General disorders Injection site reaction	33.3% 1/3 • Number of events 1 • 7 months
Nervous system disorders Memory Impairment	33.3% 1/3 • Number of events 1 • 7 months
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 4 • 7 months
Skin and subcutaneous tissue disorders Puritis	33.3% 1/3 • Number of events 1 • 7 months
Nervous system disorders Psychosis	33.3% 1/3 • Number of events 2 • 7 months
Nervous system disorders Mood Alteration	33.3% 1/3 • Number of events 1 • 7 months

Additional Information

Srdan Verstovsek M.D./Associate Professor

Organization: The University of Texas M. D. Anderson Cancer Center

Phone: 713-792-7305

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place