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A Study Evaluating MM-310 in Patients With Solid Tumors

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: NCT03076372
Recruitment Status : Unknown
Verified February 2018 by Merrimack Pharmaceuticals.
Recruitment status was:  Recruiting
First Posted : March 10, 2017
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 1, 2017
First Posted Date  ICMJE March 10, 2017
Last Update Posted Date February 27, 2018
Actual Study Start Date  ICMJE February 22, 2017
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2017)
Maximum tolerated dose (MTD) of MM-310 monotherapy administered once every 3 weeks in patients with metastatic solid tumors. [ Time Frame: 18 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2017)
  • Serum levels of analytes that comprise MM-310 [ Time Frame: 18 months ]
  • Adverse event profile using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: 18 months ]
  • Presence of human anti-human antibodies to MM-310 [ Time Frame: 18 months ]
  • Objective responses based on RECIST v1.1 or other relevant criteria [ Time Frame: 18 months ]
  • Disease Control Rate [ Time Frame: 18 months ]
  • Progression Free Survival [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating MM-310 in Patients With Solid Tumors
Official Title  ICMJE A Phase-1 Study Evaluating the Safety, Pharmacology and Preliminary Activity of MM-310 in Patients With Solid Tumors
Brief Summary MM-310 is a liposomal formulation of a docetaxel prodrug that targets the EphA2 receptor on cancer cells. Docetaxel is an approved chemotherapeutic drug.This study is a Phase 1 open-label study of MM-310 in patients with solid tumors. In the first part of the study, MM-310 will be assessed as a monotherapy until a maximum tolerated dose (MTD) is established. After an MTD of MM-310 as a monotherapy is established, an expansion cohort and MM-310 in combination with other therapies will be assessed.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumors
  • Urothelial Carcinoma
  • Gastric Carcinoma
  • Squamous Cell Carcinoma of the Head and Neck
  • Ovarian Cancer
  • Pancreatic Ductal Adenocarcinoma
  • Prostate Adenocarcinoma
  • Non-small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Triple Negative Breast Cancer
  • Endometrial Carcinoma
  • Soft Tissue Sarcoma
Intervention  ICMJE Drug: MM-310
MM-310
Study Arms  ICMJE Experimental: MM-310 monotherapy
MM-310 will be administered by IV infusion over 90 minutes on the first day of each 21 day cycle.
Intervention: Drug: MM-310
Publications * Huang ZR, Tipparaju SK, Kirpotin DB, Pien C, Kornaga T, Noble CO, Koshkaryev A, Tran J, Kamoun WS, Drummond DC. Formulation optimization of an ephrin A2 targeted immunoliposome encapsulating reversibly modified taxane prodrugs. J Control Release. 2019 Sep 28;310:47-57. doi: 10.1016/j.jconrel.2019.08.006. Epub 2019 Aug 7.

*   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: March 9, 2017)
34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must have one of the following cancers, for which the patient has either received or been intolerant to all therapy known to confer clinical benefit

    • Urothelial carcinoma
    • Gastric/gastroesophageal junction/esophageal carcinoma (G/GEJ/E)
    • Squamous Cell Carcinoma of the Head and neck (SCCHN)
    • Ovarian cancer
    • Pancreatic ductal adenocarcinoma (PDAC)
    • Prostate adenocarcinoma (PAC)
    • Non-small cell lung cancer (NSCLC)
    • Small cell lung cancer (SCLC)
    • Triple negative breast cancer (TNBC)
    • Endometrial carcinoma
    • Soft tissue sarcoma subtypes except GIST, desmoid tumors and pleomorphic rhabdomyosarcoma
  • Able to provide informed consent, or have a legal representative able and willing to do so
  • ≥ 18 years of age
  • Availability of a cancerous lesion amenable to biopsy and willing to undergo a pre-treatment biopsy
  • ECOG Performance Status of 0 or 1
  • Adequate bone marrow reserve as evidenced by:

    • ANC > 1,500/µl (unsupported by growth factors) and
    • Platelet count > 100,000/µl
    • Hemoglobin > 9 g/dL
  • Patients must have adequate coagulation function as evidenced by prothrombin time (PT), activated partial thromboplastin time (aPTT) and international normalized ratio (INR) within normal institutional limits
  • Adequate hepatic function as evidenced by:

    • Serum total bilirubin ≤ ULN
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN.
    • Alkaline phosphatase ≤ 2.5 x ULN, unless the elevated alkaline phosphatase is due to bone metastasis.
    • In case alkaline phosphatase is >2.5 x ULN patients are eligible for inclusion if aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 x ULN
  • Adequate renal function as evidenced by a serum/plasma creatinine < 1.5 x ULN
  • Recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy to CTCAE v4.03 grade 1, baseline or less, except for alopecia
  • Women of childbearing potential or fertile men and their partners must be willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 6 months following the last dose of MM-310.

Exclusion Criteria:

  • Prior treatment with docetaxel within 6 months of study enrollment
  • Pregnant or lactating
  • Treatment with systemic anticoagulation (e.g. warfarin, heparin, low molecular weight heparin, anti-Xa inhibitors, etc.) except aspirin
  • Any evidence of hematemesis, melena, hematochezia, ≥ grade 2 hemoptysis, or gross hematuria
  • Any history of hereditary bleeding disorders
  • Presence of an active infection or with an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing, which in the investigator's opinion might compromise the patient's participation in the trial or affect the study outcome. At the discretion of the investigator, patients with tumor fever may be enrolled
  • Known CNS metastases
  • Known hypersensitivity to the components of MM-310, or docetaxel
  • Prior treatment with MM-310
  • Received treatment, within 28 days or 5 half-lives, whichever is shorter, prior to the first scheduled day of dosing, with any investigational agents that have not received regulatory approval for any indication or disease state and all prior clinically significant treatment related toxicities have resolved to Grade 1 or baseline
  • Received other recent antitumor therapy including any standard chemotherapy or radiation within 14 days (or have not yet recovered from any actual toxicities of the most recent therapy) prior to the first scheduled dose of MM-310
  • Received any anti-cancer drug known to have anti-VEGF/VEGFR activity within a period of 5 half-lives of this drug (e.g. 100 days for bevacizumab, 75 days for ramucirumab) prior to the first scheduled dose of MM-310
  • Clinically significant cardiac disease, including: NYHA Class III or IV congestive heart failure, unstable angina, acute myocardial infarction within six months of planned first dose, arrhythmia requiring therapy (including torsades de pointes, with the exception of extrasystoles, minor conduction abnormalities, or controlled and well treated chronic atrial fibrillation)
  • Patients who are not appropriate candidates for participation in this clinical study for any other reason as deemed by the investigator
  • Patients who received organ or allogeneic bone marrow or peripheral blood stem cell transplants
  • Chronic use of corticosteroids more than 10mg daily prednisone equivalent during the past 4 weeks prior to planned start of MM-310
  • Concomitant use of strong inhibitors of CYP3A
  • Patients with peripheral neuropathy of grade 2 or higher
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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 NCT03076372
Other Study ID Numbers  ICMJE MM-310-01-01-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Merrimack Pharmaceuticals
Study Sponsor  ICMJE Merrimack Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Vasileios Askoxylakis, MD, PhD Merrimack
PRS Account Merrimack Pharmaceuticals
Verification Date February 2018

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