NCT01733004

Brief Summary

This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-141 at varying dose levels and frequencies.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 hepatocellular-carcinoma

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

3.2 years

First QC Date

November 20, 2012

Last Update Submit

August 3, 2016

Conditions

Hepatocellular Carcinoma

Keywords

CancerHepatocellular CarcinomaOncologyPhase IErbB3IGF-1REverolimusGemcitabineAbraxane

Outcome Measures

Primary Outcomes (1)

  • Severity and number of adverse events related to escalating doses of MM-141

    Determine the Phase II dose based either on the maximum tolerated dose (MTD) or recommended dose in patients with advanced solid malignancies.

    2 years

Study Arms (3)

Arm A

EXPERIMENTAL

MM-141 monotherapy

Drug: MM-141

Arm B

EXPERIMENTAL

MM-141 and Everolimus

Drug: MM-141

Arm C

EXPERIMENTAL

MM-141 and Abraxane and Gemcitabine

Drug: MM-141

Interventions

MM-141DRUG
Arm AArm BArm C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced malignant solid tumors for which no curative therapy exists that has recurred or pgrogressed following standard therapy
  • Eighteen years of age or above
  • Able to understand and sign an informed consent (or have a legal representative who is able to do so)
  • Measurable disease according to RECIST v1.1
  • ECOG Performance Score of 0 or 1
  • Adequate bone marrow, hepatic, renal and cardiac function
  • Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-141

You may not qualify if:

  • Active infection or fever \> 38.5°C during screening visits or on the first scheduled day of dosing
  • Symptomatic CNS disease
  • Received other recent antitumor therapy
  • Pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Marietta, Georgia, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

Villejuif, France

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularNeoplasmsInsulin-Like Growth Factor I, Resistance To

Interventions

Istiratumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Chrystal Louis, MD, MPH

    Merrimack Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2012

First Posted

November 26, 2012

Study Start

November 1, 2012

Primary Completion

January 1, 2016

Last Updated

August 4, 2016

Record last verified: 2016-08

Locations

US(3)FR(1)