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

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Benign Tumors Breast Cancer Cancer Ovarian Cancer

Drug Information available for: Paclitaxel

U.S. FDA Resources

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:

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
Adenoma
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
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Paclitaxel
Tubulin Modulators
Antimitotic Agents

ClinicalTrials.gov processed this record on May 21, 2013