Know Cancer

or
forgot password

A Phase I and Pharmocologic Study of MM-121 in Patients With Refractory Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumors

Thank you

Trial Information

A Phase I and Pharmocologic Study of MM-121 in Patients With Refractory Advanced Solid Tumors


Inclusion Criteria:



- Patients must have histologically or cytologically confirmed advanced solid tumors
that have recurred or progressed following standard therapy, or that have 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-121
(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:

Interventional

Study Design:

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

Outcome Measure:

To determine the Phase II dose based either on the maximum tolerated dose (MTD) or maximum dose of 20 mg/kg in patients with advanced solid malignancies. To describe any objective response to MM-121 based on RECIST

Outcome Time Frame:

two years

Safety Issue:

Yes

Principal Investigator

Crystal Denlinger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

MM-121-01-100

NCT ID:

NCT00734305

Start Date:

July 2008

Completion Date:

March 2013

Related Keywords:

  • Advanced Solid Tumors
  • cancer, solid tumors, oncology, Phase I, ErbB3, HER3
  • (erbB-3, HER-3)
  • Neoplasms

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
The Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232