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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733004
• Other study ID #: MM-141-01-01-01
• Status: Completed
• Phase: Phase 1
• First received: November 20, 2012
• Last updated: August 3, 2016
• Start date: November 2012

Study information

• Verified date: August 2016
• Source: Merrimack Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• MM-141

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merrimack Pharmaceuticals

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes