Clinical trial NCT01447225: Safety Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors
Official title: A Phase 1, Pharmacologic and Pharmacodynamic Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: Advanced-stage
Solid Tumors
MM-121
Carboplatin
Pemetrexed
Gemcitabine
Cabazitaxel
ErbB3
Phase I
Cancer
Lead sponsor: Merrimack Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2011-10-06
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Anticancer Therapies
timeFrame: From date of first dose to 30 days after termination, the longest 88.1 weeks
measure: To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: MM-121 Doses
timeFrame: From date of first dose to 30 days after termination, the longest 88.1 weeks
measure: To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Gemcitabine
timeFrame: From date of first dose to 30 days after termination, the longest 88.1 weeks
measure: To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Carboplatin
timeFrame: From date of first dose to 30 days after termination, the longest 88.1 weeks
measure: To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Pemetrexed
timeFrame: From date of first dose to 30 days after termination, the longest 88.1 weeks
measure: To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Cabazitaxel
timeFrame: From date of first dose to 30 days after termination, the longest 88.1 weeks
measure: To Characterize Dose-limiting Toxicities (DLTs) Associated With the Combination of MM-121 With Anticancer Therapies
timeFrame: From date of first dose to 30 days after termination, the longest 88.1 weeks
Secondary outcomes:
measure: Objective Response Rate
timeFrame: patients were assessed for response during their time on study, the longest of which was 88.1 weeks
measure: Pharmacokinetics
timeFrame: Collections taken at Cycle 1, Week 1 for all patients at start of the infusion (pretreatment), at the end of the infusion, and at 2, 4, 24 and 48 hours after the start of the MM-121 infusion
measure: Pharmacokinetics (AUClast)
timeFrame: Collections taken at Cycle 1, Week 1 for all patients at the start of the infusion (pretreatment), at the end of the infusion, and at 2, 4, 24 and 48 hours after the start of the MM-121 infusion
measure: Immunogenicity
timeFrame: Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 88.1 weeks, and a collection was made post-infusion in any case of infusion reaction
Other outcomes:
Locations:
city: Lafayette
country: United States
state: Indiana
city: Buffalo
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Villejuif
country: France
Study officials:
affiliation: Merrimack Pharmaceuticals
name: Victor Moyo, MD
role: STUDY_DIRECTOR
References: