Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01304797
Recruitment Status : Unknown
Verified January 2017 by Merrimack Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : February 25, 2011
Last Update Posted : January 6, 2017
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE February 24, 2011
First Posted Date  ICMJE February 25, 2011
Last Update Posted Date January 6, 2017
Study Start Date  ICMJE March 2011
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2013)
  • The severity and the number of adverse events related to escalating doses of the MM-302. [ Time Frame: 12 months ]
  • The severity and the number of adverse events related to escalating doses of the MM-302 in combination with trastuzumab with or without cyclophosphamide [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2011)
The severity and the number of adverse events related to escalating doses of the MM-302. [ Time Frame: 12 months ]
Change History Complete list of historical versions of study NCT01304797 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2011)
  • Objective response rate of MM-302 [ Time Frame: 12 months ]
  • The pharmacokinetics of MM-302 as determined by measuring AUC, Tmax and Cmax [ Time Frame: 12 months ]
  • Immunogenicity of MM-302 by confirming whether MM-302 elicits an immune response or not [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced Breast Cancer
Official Title  ICMJE 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
Brief Summary This study is a Phase 1 and pharmacologic open-label 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 pharmacologic endpoints. Additional arms will be enrolled to explore the combination of MM-302 with trastuzumab or trastuzumab plus cyclophosphamide in patients with advanced HER2 positive breast cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: MM-302 Monotherapy
    Escalating doses of MM-302 as a single agent
  • Drug: MM-302 in combination with trastuzumab
    Escalating MM-302 at an every 4 week dosing schedule, while the dose of trastuzumab is fixed at an every 2 week dosing schedule
    Other Name: Herceptin
  • Drug: MM-302 in combination with trastuzumab q3w
    Escalating MM-302 at an every 3 week dosing schedule, while the dose of trastuzumab is fixed at an every 3 week dosing schedule
    Other Name: herceptin
  • Drug: MM-302 in combination with trastuzumab and cyclophosphamide
    Escalating MM-302 at an every 3 week dosing schedule, while the dose of trastuzumab and cyclophosphamide is fixed at an every 3 week dosing schedule
    Other Names:
    • herceptin
    • cytoxan; neosar
Study Arms
  • Experimental: MM-302
    Intervention: Drug: MM-302 Monotherapy
  • Experimental: MM-302 in Combination with Trastuzumab
    Intervention: Drug: MM-302 in combination with trastuzumab
  • Experimental: MM-302 in Combination with Trastuzumab q3w
    Intervention: Drug: MM-302 in combination with trastuzumab q3w
  • Experimental: MM-302 in Combination with Trastuzumab and Cyclophosphamide
    Intervention: Drug: MM-302 in combination with trastuzumab and cyclophosphamide
Publications * Lee H, Shields AF, Siegel BA, Miller KD, Krop I, Ma CX, LoRusso PM, Munster PN, Campbell K, Gaddy DF, Leonard SC, Geretti E, Blocker SJ, Kirpotin DB, Moyo V, Wickham TJ, Hendriks BS. (64)Cu-MM-302 Positron Emission Tomography Quantifies Variability of Enhanced Permeability and Retention of Nanoparticles in Relation to Treatment Response in Patients with Metastatic Breast Cancer. Clin Cancer Res. 2017 Aug 1;23(15):4190-4202. doi: 10.1158/1078-0432.CCR-16-3193. Epub 2017 Mar 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 10, 2013)
75
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2011)
60
Estimated Study Completion Date January 2017
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01304797
Other Study ID Numbers  ICMJE MM-302-02-01-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Merrimack Pharmaceuticals
Study Sponsor  ICMJE Merrimack Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Merrimack Pharmaceuticals
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP