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A Phase 1, Pharmacologic and Pharmacodynamic Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Locally Advanced/Metastatic or Recurrent Ovarian Cancer, Fallopian Tube Cancer,, Primary Peritoneal Cancer or Endometrial Cancer, Locally Advanced/Metastatic Her2 Non Overexpressing Breast Cancer

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Trial Information

A Phase 1, Pharmacologic and Pharmacodynamic Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers


Inclusion Criteria:



- Cytological or histological confirmation of locally advanced/metastatic or recurrent
epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or
endometrial cancer; OR, cytological or histological confirmation of locally advanced
/metastatic Her2 non-overexpressing breast cancer

- Eighteen years of age or above

- Candidates for chemotherapy

- 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 (PS) of ≤ 2

- 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-121

Exclusion Criteria:

- Prior radiation therapy to >25% of bone marrow-bearing areas

- Evidence of any other active malignancy

- 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-121 or who have had
hypersensitivity reactions to fully human monoclonal antibodies

- Received treatment, within 30 days prior to the first scheduled day of dosing, with
any investigational agents that have not received regulatory approval for any
indication or disease state

- Pregnant or breast feeding

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Assessing number and severity of adverse events related to escalating doses of the MM-121 and paclitaxel combination

Outcome Time Frame:

18 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

MM-121-04-01-04

NCT ID:

NCT01209195

Start Date:

October 2010

Completion Date:

December 2013

Related Keywords:

  • Locally Advanced/Metastatic or Recurrent Ovarian Cancer, Fallopian Tube Cancer,
  • Primary Peritoneal Cancer or Endometrial Cancer
  • Locally Advanced/Metastatic Her2 Non Overexpressing Breast Cancer
  • Breast Neoplasms
  • Endometrial Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Adenoma

Name

Location

Comprehensive Blood and Cancer CenterBakersfield, California  93309
Pinnacle Oncology HematologyScottsdale, Arizona  85258
Dana-Farber Cancer InstitueBoston, Massachusetts  02115