Know Cancer

forgot password

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

Phase 1
18 Years
Open (Enrolling)
Advanced Solid Tumors

Thank you

Trial Information

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

This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3"
design. Successive cohorts of three or more patients will be treated at escalating doses
until a maximum tolerated dose is identified. The study will explore a weekly dosing
schedule, an every other week dosing schedule and an every three week dosing schedule. An
Expansion Cohort will be enrolled following demonstration of safety and adequate MM-151
concentration levels in the dose escalation phase. The expansion cohort will further
characterize safety, pharmacokinetics and explore pharmacodynamic endpoints. It is expected
that approximately 4 study sites will participate.

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

Type of Study:


Study Design:

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

Outcome Measure:

Phase II dose based either on the maximum tolerated dose (MTD) or maximum dose of 18 mg/kg in patients with advanced solid malignancies.

Outcome Time Frame:

Two years

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2012

Completion Date:

February 2014

Related Keywords:

  • Advanced Solid Tumors
  • cancer
  • solid tumors
  • oncology
  • Phase I
  • EGFR
  • EGF receptor (ErbB1)
  • Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263
University of Colorado Denver Denver, Colorado  80262
Horizon Oncology Research, Inc. Lafayette, Indiana  
South Texas Accelerated Research Therapeutics, LLC (START) San Antonio, Texas  78229