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Completed

NCT Number: NCT01733004

A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Insulin-Like Growth Factor I, Resistance To Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Villejuif, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

MM-141

Drug

Primary outcomes

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

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Merrimack Pharmaceuticals

Industry

Registry information

Important dates

Study start
2012
Primary completion
2016
First posted
Nov 26, 2012
Registry last updated
Aug 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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