Safety Study of the Drug MM-151 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment

NCT01520389 | Completed Phase 1

• 1 other identifier: MM-151-01-01-01
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 4

Brief Summary

This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-151 at varying dose levels and frequencies, and subsequently in combination with irinotecan.

Conditions

Advanced Solid Tumors; Colorectal Cancer; Squamous Cell Head and Neck Cancer; Non Small Cell Lung Cancer; Triple Negative Breast Cancer

Keywords

cancer; solid tumors; oncology; Phase I; EGFR; EGF receptor (ErbB1); irinotecan

Outcome Measures

Primary Outcomes (1)

• Phase II dose of MM-151 alone and in combination with irinotecan based either on the maximum tolerated dose (MTD) or maximum dose of 18 mg/kg in patients with advanced solid malignancies.

  Two years

Secondary Outcomes (3)

• Number of dose limiting toxicities (DLTs) within a cohort

  2 years

• Adverse event profile of MM-151 alone and in combination with irinotecan

  2 years

• Objective response to MM-151 alone and in combination with irinotecan based on RECIST

  2 years

Study Arms (3)

MM-151 Dose Escalation

EXPERIMENTAL

MM-151 Dose escalation frequency - once weekly, once every two weeks, once every three weeks

Drug: MM-151

MM-151 Expansion in KRAS wild type colorectal cancer

EXPERIMENTAL

MM-151 given weekly

Drug: MM-151

MM-151 + irinotecan

EXPERIMENTAL

MM-151 given weekly, irinotecan 180 mg/m2 given once every two weeks

Drug: MM-151 + irinotecan

Interventions

MM-151 DRUG

MM-151

MM-151 Dose Escalation; MM-151 Expansion in KRAS wild type colorectal cancer

MM-151 + irinotecan DRUG

MM-151 + irinotecan

Also known as: camptosar

MM-151 + irinotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed advanced malignant solid tumor that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy, or who are not candidates for standard therapy
• Patients must be \> 18 years of age
• Patients of their legal representatives must be able to understand and sign an informed consent form
• Patients must have evaluable or measurable tumor(s)
• Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy. Up to CTCAE Grade 1 is acceptable for patients with known peripheral neuropathy
• Women of childbearing potential as well as fertile men and their partners must agree 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-151 (an effective form of contraception is an oral contraceptive or a double barrier method)

You may not qualify if:

• Patients for whom potentially curative antineoplastic therapy is available
• Patients who are pregnant or lactating
• Patients with an active infection or with an unexplained fever \> 38.5°C during screening visits or on the first scheduled day of dosing. (At the discretion of the investigator, patients with tumor fever may be enrolled.)
• Patients with untreated and/or symptomatic CNS malignancies (primary or metastatic); patients with CNS metastases who have undergone surgery or radiotherapy, whose disease is stable, and who have been on a stable dose of corticosteroids for at least 2 weeks prior to the first scheduled day of dosing will be eligible for the trial

Sponsors & Collaborators

• Merrimack Pharmaceuticals: lead

Study Sites (4)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Horizon Oncology Research, Inc.

Lafayette, Indiana, 47905, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

South Texas Accelerated Research Therapeutics, LLC (START)

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Triple Negative Breast Neoplasms; Neoplasms

Interventions

MM-151; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 30, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: March 21, 2018

Record last verified: 2018-03

Locations

US (4)