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

Primary Purpose

Advanced Solid Tumors, Colorectal Cancer, Squamous Cell Head and Neck Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

MM-151

MM-151 + irinotecan

About this trial

This is an interventional treatment trial for Advanced Solid Tumors focused on measuring cancer, solid tumors, oncology, Phase I, EGFR, EGF receptor (ErbB1), irinotecan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Colorado Denver
Horizon Oncology Research, Inc.
Roswell Park Cancer Institute
South Texas Accelerated Research Therapeutics, LLC (START)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

MM-151 Dose Escalation

MM-151 Expansion in KRAS wild type colorectal cancer

MM-151 + irinotecan

Arm Description

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

MM-151 given weekly

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

Outcomes

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.

Secondary Outcome Measures

Number of dose limiting toxicities (DLTs) within a cohort

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

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

Full Information

NCT ID

NCT01520389

First Posted

January 13, 2012

Last Updated

March 20, 2018

Sponsor

Merrimack Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01520389

Brief Title

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

Official Title

A Phase 1 and Pharmacologic Study of MM-151 in Patients With Refractory Advanced Solid Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merrimack Pharmaceuticals

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MM-151 Dose Escalation

Arm Type

Experimental

Arm Description

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

Arm Title

MM-151 Expansion in KRAS wild type colorectal cancer

Arm Type

Experimental

Arm Description

MM-151 given weekly

Arm Title

MM-151 + irinotecan

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

MM-151

Intervention Description

MM-151

Intervention Type

Drug

Intervention Name(s)

MM-151 + irinotecan

Other Intervention Name(s)

camptosar

Intervention Description

MM-151 + irinotecan

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Number of dose limiting toxicities (DLTs) within a cohort

Time Frame

2 years

Title

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

Time Frame

2 years

Title

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

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

University of Colorado Denver

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Horizon Oncology Research, Inc.

City

Lafayette

State/Province

Indiana

ZIP/Postal Code

47905

Country

United States

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

Facility Name

South Texas Accelerated Research Therapeutics, LLC (START)

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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