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A Study Evaluating MM-310 in Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT03076372
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
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 Drug: MM-310 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase-1 Study Evaluating the Safety, Pharmacology and Preliminary Activity of MM-310 in Patients With Solid Tumors
Actual Study Start Date : February 22, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: MM-310 monotherapy
MM-310 will be administered by IV infusion over 90 minutes on the first day of each 21 day cycle.
Drug: MM-310
MM-310




Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of MM-310 monotherapy administered once every 3 weeks in patients with metastatic solid tumors. [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Serum levels of analytes that comprise MM-310 [ Time Frame: 18 months ]
  2. Adverse event profile using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: 18 months ]
  3. Presence of human anti-human antibodies to MM-310 [ Time Frame: 18 months ]
  4. Objective responses based on RECIST v1.1 or other relevant criteria [ Time Frame: 18 months ]
  5. Disease Control Rate [ Time Frame: 18 months ]
  6. Progression Free Survival [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076372


Contacts
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Contact: Vasileios Askoxylakis, MD, PhD 617.441.7492 VAskoxylakis@merrimack.com

Locations
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United States, Arizona
Honor Health Recruiting
Scottsdale, Arizona, United States, 85259
United States, California
University California San Francisco Recruiting
San Francisco, California, United States, 94143
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55902
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Merrimack Pharmaceuticals
Investigators
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Study Director: Vasileios Askoxylakis, MD, PhD Merrimack

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03076372     History of Changes
Other Study ID Numbers: MM-310-01-01-01
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Merrimack Pharmaceuticals:
Cancer
Oncology
Phase I
Gemcitabine
Carboplatin
MM-310
EphA2
Ephrin A2
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
Merrimack

Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Adenocarcinoma
Sarcoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Small Cell Lung Carcinoma
Triple Negative Breast Neoplasms
Carcinoma, Transitional Cell
Squamous Cell Carcinoma of Head and Neck
Endometrial Neoplasms
Prostatic Neoplasms
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Connective and Soft Tissue
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases