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BRIEF TITLE: Study Evaluating the Safety, Pharmacology and Preliminary Activity of MM-310 in Patients With Solid Tumors

A Phase-1 Study Evaluating the Safety, Pharmacology and Preliminary Activity of MM-310 in Patients With Solid Tumors


  • Org Study ID: MM-310-01-01-01
  • Secondary ID:
  • NCT ID: NCT03076372
  • NCT Alias:
  • Sponsor: Merrimack Pharmaceuticals - Industry
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting February 22, 2017 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Maximum tolerated dose (MTD) of MM-310 monotherapy administered once every 3 weeks in patients with metastatic solid tumors.

Primary Outcome 1 - Time Frame: 18 months

Condition:

  • 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

Eligibility

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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Vasileios Askoxylakis, MD, PhD

Role: Study Director

Affiliation: Merrimack

Overall Contact

Name: Vasileios Askoxylakis, MD, PhD

Phone: 617.441.7492

Email: VAskoxylakis@merrimack.com

Locations

Facility Status Contact
Honor Health
Scottsdale, Arizona 85259
United States
Recruiting
University California San Francisco
San Francisco, California 94143
United States
Recruiting
Mayo Clinic
Rochester, Minnesota 55902
United States
Recruiting
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Recruiting
Duke University
Durham, North Carolina 27710
United States
Recruiting