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A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, and Pharmacokinetic Clinical Study of Intravenously Administered MM-302 Monotherapy and in Combination With Trastuzumab With or Without Cyclophosphamide in Patients With Advanced HER2 Positive Breast Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

Thank you

Trial Information

A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, and Pharmacokinetic Clinical Study of Intravenously Administered MM-302 Monotherapy and in Combination With Trastuzumab With or Without Cyclophosphamide in Patients With Advanced HER2 Positive Breast Cancer


Inclusion Criteria:



- Locally advanced/unresectable or metastatic breast cancer

- Eighteen years of age or above

- Able to understand and sign an informed consent (or have a legal representative who
is able to do so)

- Measurable disease according to RECIST v1.1

- ECOG Performance Score of 0 or 1

- Adequate bone marrow, hepatic, renal and cardiac function

- Willing 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-302

Exclusion Criteria:

- Patients for whom potentially curative anticancer therapy is available

- Active infection or fever > 38.5°C during screening visits or on the first scheduled
day of dosing

- Symptomatic CNS disease

- Known hypersensitivity to any of the components of MM-302 or who have had
hypersensitivity reactions to fully human monoclonal antibodies

- Received other recent antitumor therapy

- Pregnant or breast feeding

- Patients with any other medical or psychological condition, deemed by the
Investigator to be likely to interfere with a patient's ability to sign informed
consent, cooperate and participate in the study, or interfere with the interpretation
of the results

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The severity and the number of adverse events related to escalating doses of the MM-302.

Outcome Time Frame:

12 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

MM-302-02-01-01

NCT ID:

NCT01304797

Start Date:

March 2011

Completion Date:

March 2014

Related Keywords:

  • Breast Cancer
  • MM302
  • Breast Cancer
  • Locally advanced/unresectable
  • metastatic
  • Breast Neoplasms

Name

Location

University of California San FranciscoSan Francisco, California  941104206
Washington UniversitySt. Louis, Missouri  63110
Karmanos Cancer CenterDetroit, Michigan  48201
Dana Farber Cancer CenterBoston, Massachusetts  02115
University of IndianaIndianapolis, Indiana