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

NCT ID: NCT01447225

Last Updated: 2016-09-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MM-121 plus Gemcitabine

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

Group Type EXPERIMENTAL

MM-121

Intervention Type DRUG

MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV

Gemcitabine

Intervention Type DRUG

administered IV at 1000 mg/m2 or 1250 mg/m2

MM-121 plus Carboplatin

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

Group Type EXPERIMENTAL

MM-121

Intervention Type DRUG

MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV

Carboplatin

Intervention Type DRUG

administered at AUC 6

MM-121 plus Pemetrexed

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

Group Type EXPERIMENTAL

MM-121

Intervention Type DRUG

MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV

Pemetrexed

Intervention Type DRUG

administered IV at 500 mg/m2

MM-121 plus Cabazitaxel

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

Group Type EXPERIMENTAL

MM-121

Intervention Type DRUG

MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV

Cabazitaxel

Intervention Type DRUG

administered IV at 20 mg/m2 or 25 mg/m2

Interventions

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MM-121

MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV

Intervention Type DRUG

Carboplatin

administered at AUC 6

Intervention Type DRUG

Pemetrexed

administered IV at 500 mg/m2

Intervention Type DRUG

Cabazitaxel

administered IV at 20 mg/m2 or 25 mg/m2

Intervention Type DRUG

Gemcitabine

administered IV at 1000 mg/m2 or 1250 mg/m2

Intervention Type DRUG

Other Intervention Names

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Seribantumab, SAR256212 ALIMTA Jevtana Gemzar

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Merrimack Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Victor Moyo, MD

Role: STUDY_DIRECTOR

Merrimack Pharmaceuticals

Locations

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Lafayette, Indiana, United States

Site Status

Buffalo, New York, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Villejuif, , France

Site Status

Countries

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United States France

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id

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