Trial record 1 of 1 for:    NCT01520389
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Merrimack Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01520389
First received: January 13, 2012
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Advanced Solid Tumors
Colorectal Cancer
Squamous Cell Head and Neck Cancer
Non Small Cell Lung Cancer
Triple Negative Breast Cancer
Drug: MM-151
Drug: MM-151 + irinotecan
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 and Pharmacologic Study of MM-151 in Patients With Refractory Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:
  • 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. [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of dose limiting toxicities (DLTs) within a cohort [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Adverse event profile of MM-151 alone and in combination with irinotecan [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Objective response to MM-151 alone and in combination with irinotecan based on RECIST [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 115
Study Start Date: January 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MM-151 Dose Escalation
MM-151 Dose escalation frequency - once weekly, once every two weeks, once every three weeks
Drug: MM-151
MM-151
Experimental: MM-151 Expansion in KRAS wild type colorectal cancer
MM-151 given weekly
Drug: MM-151
MM-151
Experimental: MM-151 + irinotecan
MM-151 given weekly, irinotecan 180 mg/m2 given once every two weeks
Drug: MM-151 + irinotecan
MM-151 + irinotecan
Other Name: camptosar

Detailed Description:

This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design exploring weekly, bi-weekly, and tri-weekly dosing schedules. Successive MM-151 monotherapy cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified, and subsequently in combination with irinotecan. The study consists of three parts as follows: MM-151 monotherapy dose escalation (Part 1); MM-151 monotherapy expansion cohort in cetuximab-refractory colorectal cancer (Part 2); MM-151 + irinotecan dose escalation (Part 3). It is expected that approximately 4 study sites will participate.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01520389

Locations
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Chris Lieu, MD    303-724-6390    christopher.lieu@ucdenver.edu   
Principal Investigator: Chris Lieu, MD         
United States, Indiana
Horizon Oncology Research, Inc. Recruiting
Lafayette, Indiana, United States, 47905
Contact: Wael Harb, MD    765-446-5111    wharb1@iuhealth.org   
Principal Investigator: Wael Harb, MD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Alex Adjei, MD    716-845-4101    alex.adjei@roswellpark.org   
Principal Investigator: Alex Adjei, MD         
United States, Texas
South Texas Accelerated Research Therapeutics, LLC (START) Recruiting
San Antonio, Texas, United States, 78229
Contact: Muralidhar Beeram, MD    210-593-5250    murali.beeram@stoh.com   
Principal Investigator: Muralidhar Beeram, MD         
Sponsors and Collaborators
Merrimack Pharmaceuticals
  More Information

No publications provided

Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01520389     History of Changes
Other Study ID Numbers: MM-151-01-01-01
Study First Received: January 13, 2012
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merrimack Pharmaceuticals:
cancer
solid tumors
oncology
Phase I
EGFR
EGF receptor (ErbB1)
irinotecan

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Neoplasms
Colorectal Neoplasms
Head and Neck Neoplasms
Breast Neoplasms
Triple Negative Breast Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Breast Diseases
Skin Diseases
Irinotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 30, 2014