Safety Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors

Merrimack Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: Cabazitaxel; Drug: Pemetrexed; Drug: MM-121; Drug: Gemcitabine; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01447225

MM-121-06-01-06 (TCD11694)

Details and patient eligibility

About

To evaluate the safety and tolerability of escalating doses of MM-121 + certain anticancer therapies

Full description

This study was a Phase 1 and pharmacologic dose-escalation trial of MM-121 in combination with certain anticancer therapies. The dose-escalation portion of the study employed a 3 + 3 design to assess the safety, tolerability, and pharmacokinetics of MM-121 administered weekly in combination with certain anticancer therapies in patients with advanced/recurrent cancer. Doses of MM-121 and/or the anticancer therapy were escalated until either the MTD is identified or the combination was shown to be tolerable at the highest planned doses.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced-stage solid tumors
• ≥ 18 years of age
• Adequate liver and kidney function

Exclusion criteria

• Any other active malignancy
• No known HIV, Hepatitis C or B

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 4 patient groups

MM-121 plus Gemcitabine

Experimental group

Description:

escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle

Treatment:

Drug: Gemcitabine

Drug: MM-121

MM-121 plus Carboplatin

Experimental group

Description:

carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle

Treatment:

Drug: MM-121

Drug: Carboplatin

MM-121 plus Pemetrexed

Experimental group

Description:

pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle

Treatment:

Drug: MM-121

Drug: Pemetrexed

MM-121 plus Cabazitaxel

Experimental group

Description:

escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle

Treatment:

Drug: MM-121

Drug: Cabazitaxel