Trial Outcomes & Findings for A Study of MM-111 in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Cancers (NCT NCT00911898)

NCT ID: NCT00911898

Last Updated: 2015-01-13

Results Overview

The Maximum Tolerated Dose (MTD) was defined as the highest dose level in which a DLT is experienced by fewer than two patients in a cohort of 3 - 6 patients. If a DLT is observed in at least two patients in a cohort of 3 - 6 patients, the MTD will be determined to have been exceeded and an additional three patients (up to a total of six) are to be treated at the next lower dose level.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 20 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2015-01-13

Participant Flow

Participant milestones

Measure	MM-111 MM-111: For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of MM-111 in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Cancers

Baseline characteristics by cohort

Measure	MM-111 n=20 Participants MM-111: For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
Age, Continuous	61.0 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

The Maximum Tolerated Dose (MTD) was defined as the highest dose level in which a DLT is experienced by fewer than two patients in a cohort of 3 - 6 patients. If a DLT is observed in at least two patients in a cohort of 3 - 6 patients, the MTD will be determined to have been exceeded and an additional three patients (up to a total of six) are to be treated at the next lower dose level.

Outcome measures

Measure	MM-111 n=20 Participants All participants
Maximum Tolerated Dose (MTD) or Maximum Feasible Dose	NA mg/kg Interval 4.4 to 8.0 MTD was not attained as no patients experienced a dose limiting toxicity.

SECONDARY outcome

Timeframe: December 2011

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: December 2011

Outcome measures

Outcome data not reported

Adverse Events

MM-111

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	MM-111 n=20 participants at risk MM-111: For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
General disorders Disease Progression	5.0% 1/20
Respiratory, thoracic and mediastinal disorders Peural effusion	5.0% 1/20
Infections and infestations Acute viral myocarditis	5.0% 1/20

Other adverse events

Measure	MM-111 n=20 participants at risk MM-111: For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
General disorders Fatigue	25.0% 5/20

Additional Information

Dr. Muralibhar Beeram

South Texas Accelerated Research Therapeutics

Phone: 210-593-5921

Email: murali.beeram@stoh.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place