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A Phase I/II, Two-Part, Multicenter Study to Evaluate the Safety and Efficacy of M402 in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Pancreatic Cancer

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Trial Information

A Phase I/II, Two-Part, Multicenter Study to Evaluate the Safety and Efficacy of M402 in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer


Part A is an open-label, multiple ascending dose patient study of M402 given first as a
single dose and then daily in combination with the nab-paclitaxel and gemcitabine regimen.
It will be conducted to evaluate the safety and tolerability of M402 alone and in
combination with nab-paclitaxel and gemcitabine and to recommend an M402 dose regimen for
subsequent evaluation in Part B. Part B is a randomized, double-blind study investigating
the antitumor activity of M402 in combination with nab-paclitaxel and gemcitabine compared
with nab-paclitaxel, gemcitabine, and placebo. In both Parts A and B, a treatment period
consists of one 28-day cycle. The Study Patient and Investigator can decide to continue with
additional 28-day cycles according to the patient's status at the end of each 28-day cycle.
Only Part A is currently open.

Part A - Primary Objectives:

- To evaluate the safety and tolerability of M402 in combination with nab-paclitaxel and
gemcitabine.

- To determine the dose of M402 to be carried forward into Part B.

Part B - Primary Objective:

To evaluate overall survival in patients treated with M402 + nab-paclitaxel + gemcitabine
compared with placebo + nab-paclitaxel + gemcitabine.


Inclusion Criteria:



- Age of 18 years or older

- Confirmed pancreatic ductal adenocarcinoma

- Metastatic disease as documented by CT scan or MRI (locally advanced disease only NOT
eligible)

- At least 1 site of disease measurable by RECIST ver1.1

- ECOG performance status of 0 to 1

- Adequate bone marrow, renal capacity and hepatic function

- Willing to administer daily subcutaneous injections at home

Exclusion Criteria:

- Any prior radiotherapy, chemotherapy, surgery, or investigational therapy for
adjuvant or metastatic pancreatic cancer

- Brain metastasis or active second malignancy

- History of suspected history, or presence of heparin induced toxicity (w/ or w/o
thrombosis)

- History of unexplained bleeding episodes within 3 months of M402 dosing

- Received thrombolytic agents w/in the previous month

- Had full-dose anticoagulation with heparin, enoxaparin, dalteparin, other LMWH, a/or
other anticoagulants w/in 90 days before first dose of M402

- Used NSAIDs, ASA (except ≤ 81 mg) for at least 10 days of the preceding 14 days
before screening

- High cardiovascular risk, including but not limited to, recent coronary stenting or
myocardial infarction in the past year

- Major trauma or surgery w/in prior 4 weeks

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Part A: Safety

Outcome Description:

At baseline and then each of 6 visits after the start of dosing in a 28-day treatment cycle, adverse event surveillance, liver function enzyme levels, WBC with differential, ANC, aPTT, and PT are measured. This is repeated for each 28 day treatment cycle until disease progression or end of treatment. A final assessment is performed 30 days post-final M402 dose.

Outcome Time Frame:

Part A: Baseline to 28 days after first-dose and end of study

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

M402-103

NCT ID:

NCT01621243

Start Date:

May 2012

Completion Date:

January 2016

Related Keywords:

  • Metastatic Pancreatic Cancer
  • gemcitabine
  • M402
  • heparin
  • low molecular weight heparin
  • nab-Paclitaxel
  • Pancreatic Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Gabrail Cancer CenterCanton, Ohio  44718
University of Texas Health Sciences CenterSan Antonio, Texas  
Institute of Translational Oncology ResearchGreenville, South Carolina  29605