A Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers

This study is currently recruiting participants.
Verified February 2013 by Merrimack Pharmaceuticals
Sponsor:
Information provided by:
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01209195
First received: September 23, 2010
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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. Once the maximum tolerated dose is identified, an Expansion Cohort will be enrolled at that dose to further characterize safety and to explore pharmacodynamic endpoints.


Condition Intervention Phase
Locally Advanced/Metastatic or Recurrent Ovarian Cancer, Fallopian Tube Cancer,
Primary Peritoneal Cancer or Endometrial Cancer
Locally Advanced/Metastatic Her2 Non Overexpressing Breast Cancer
Drug: MM-121 plus Paclitaxel
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Pharmacologic and Pharmacodynamic Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers

Resource links provided by NLM:


Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:
  • Assessing number and severity of adverse events related to escalating doses of the MM-121 and paclitaxel combination [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterize the efficacy of the combination of MM-121 and paclitaxel using objective response rate and clinical benefit rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To determine the pharmacokinetics (PK) of MM-121 when administered in combination with paclitaxel by measuring AUC, Tmax and Cmax [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To determine whether MM-121, when administered in combination with paclitaxel, elicits an immune response [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: October 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: MM-121 plus Paclitaxel

    Cohort 1:

    MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV

    Cohort 2:

    MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV

    Intermediate doses between cohorts 1 and 2 may also be considered.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01209195

Contacts
Contact: Victor Moyo, MD 617 441 1000

Locations
United States, Arizona
Pinnacle Oncology Hematology Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Nancy-Michelle Medina       nmedina@azpoh.com   
United States, California
Comprehensive Blood and Cancer Center Recruiting
Bakersfield, California, United States, 93309
Contact: Bobbie Wyatt       bwyatt@cbccusa.com   
United States, Massachusetts
Dana-Farber Cancer Institue Recruiting
Boston, Massachusetts, United States, 02115
Contact: Christine Lundquist       christinem_lundquist@dfci.harvard.edu   
Sponsors and Collaborators
Merrimack Pharmaceuticals
  More Information

No publications provided

Responsible Party: MM-121 Clinical Trial Manager, Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01209195     History of Changes
Other Study ID Numbers: MM-121-04-01-04
Study First Received: September 23, 2010
Last Updated: February 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Endometrial Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014