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Metastatic Pancreatic CancerPhase 1/2NCT01621243

M402 in Combination With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer

A Phase 1/2 study testing nab-paclitaxel, gemcitabine and Necuparanib in people with Metastatic Pancreatic Cancer, run by Momenta Pharmaceuticals, Inc. at 37 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

People with primary metastatic pancreatic cancer will be treated with nab-paclitaxel and gemcitabine in combination with an investigational agent called necuparanib (M402). It is made from heparin, which is a well known blood thinner. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
nab-paclitaxel, gemcitabine and Necuparanib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
128 participants
Where
37 sitesin 2 countries
Study dates
May 2012to 24 Oct 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

37 sites in 2 countries.

37 sites in 2 countries

United States34 sites

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48105

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

  • University of Colorado School of Medicine - Division of Medical Oncology

    Aurora, Colorado, 80045

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Ohio State University

    Columbus, Ohio, 43210

  • Karmanos Cancer Center

    Detroit, Michigan, 48201

  • Poudre Valley Health System

    Fort Collins, Colorado, 80528

  • Cancer Center of the Carolinas/ITOR

    Greenville, South Carolina, 29605

  • Penn State Hershey Cancer Center

    Hershey, Pennsylvania, 17033

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805

  • University of Kansas Cancer Center

    Kansas City, Missouri, 64154

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Crescent City Research Consortium

    Marrero, Louisiana, 70072

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Hartford Healthcare Cancer Institute at Midstate Medical Center

    Meriden, Connecticut, 06451

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Southeastern Regional Medical Center

    Newnan, Georgia, 30265

  • Northwest Cancer Specialists

    Portland, Oregon, 97227

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Metro-Minnesota Community Clinical Oncology Program

    Saint Louis Park, Minnesota, 55416

  • University of Texas Health Sciences Center

    San Antonio, Texas, 78229

  • Florida Hospital Tampa

    Tampa, Florida, 33613

  • Montefiore-Einstein Center for Cancer Care

    The Bronx, New York, 10461

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • University of Maryland- St Joseph's Medical Center

    Towson, Maryland, 21204

  • Arizona Clinical Research Center

    Tucson, Arizona, 85715

  • University of Arizona

    Tucson, Arizona, 85719

  • Texas Oncology, P.A.

    Tyler, Texas, 75702

  • Texas Oncology

    Tyler, Texas, 75702

  • Umass Memorial Medical Center

    Worcester, Massachusetts, 01605

Other trials in United States

Canada3 sites

  • CHUM Hospital St-Luc

    Montreal, Quebec, H2X 3J4

  • The Ottawa Hospital Cancer Center

    Ottawa, Ontario, K1H 8L6

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: 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

People with primary metastatic pancreatic cancer will be treated with nab-paclitaxel and gemcitabine in combination with an investigational agent called necuparanib (M402). It is made from heparin, which is a well known blood thinner. Blood thinners have been shown in prior animal and human studies to have anti-cancer effects. Necuparanib has been re-engineered from heparin to have much lower blood thinning activity while keeping the anti-tumor activity. The investigators are testing whether necuparanib administered in combination with nab-paclitaxel and gemcitabine may be more effective than nab-paclitaxel and gemcitabine.

Read the detailed description

Part A was an open-label, multiple ascending dose patient study of necuparanib given first as a single dose and then daily in combination with the nab-paclitaxel and gemcitabine regimen. It was conducted to evaluate the safety and tolerability of necuparanib alone and in combination with nab-paclitaxel and gemcitabine and to recommend a necuparanib dose regimen for subsequent evaluation in Part B. Part B is a randomized, double-blind study investigating the antitumor activity of necuparanib 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. Part A has completed enrollment and Part B is currently open.

Part A - Primary Objectives:

  • To evaluate the safety and tolerability of necuparanib in combination with nab-paclitaxel and gemcitabine.
  • To determine the dose of necuparanib to be carried forward into Part B.

Part B - Primary Objective:

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

Being tested
nab-paclitaxel, gemcitabine, placebo, Necuparanib
Keywords
necuparanib, gemcitabine, heparin, low molecular weight heparin, nab-Paclitaxel
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nab-paclitaxelDrug

    Also called Abraxane (nab-paclitaxel)

    nab-paclitaxel dosed on Day 1, Day 8, Day 15 of each 28-day cycle

  • gemcitabineDrug

    Also called Gemzar (gemcitabine)

    gemcitabine will be dosed on Day 1, Day 8, Day 15 of each 28-day cycle

  • placeboDrug

    Placebo will be dosed daily

  • NecuparanibDrug

    Necuparanib will be dosed daily

Study groups in NCT01621243
Study groupRoleWhat they receive
nab-paclitaxel, gemcitabine, placeboPlacebo comparatorPart A: Not applicable. Part B: nab-paclitaxel, gemcitabine, and placebo. Placebo administered daily along with nab-paclitaxel and gemcitabine administration on Day 1, Day 8, and Day 15 of each 28-day cycle.
Receives: Drug: nab-paclitaxel; Drug: gemcitabine; Drug: placebo
nab-paclitaxel, gemcitabine, necuparanibExperimentalPart A: Following a single-dose of necuparanib and a 7-day follow-up period, necuparanib was administered daily along with nab-paclitaxel and gemcitabine administration on Day 1, Day 8, and Day 15 of each 28-day cycle. Dose escalation of necuparanib proceeded by cohort in a 3+3 design. Part B: A fixed dose of necuparanib will be administered daily along with nab-paclitaxel and gemcitabine administration on Day 1, Day 8, and Day 15 of each 28-day cycle.
Receives: Drug: nab-paclitaxel; Drug: gemcitabine; Drug: Necuparanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Safety

    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 necuparanib dose.

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

  2. Part B: Overall Survival

    Time in months from first dose of study medication until death

    Measured: Time in months from first dose of study medication until death

Secondary outcomes (2)

  1. Part A: Maximum concentration of necuparanib

    One before and seven blood samples after the first dose followed by 5 additional lab draws, once at each of the 5 remaining visits in the first 28-day cycle.

    Measured: Baseline to 28 days after first dose.

  2. Part B: Duration of progression-free survival

    Time in months from first dose of study drug until disease progression

    Measured: Time from first dose of study drug until disease progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2012 (estimated)
  2. Study startMay 2012
  3. Primary completion24 Oct 2016
  4. Study completion24 Oct 2016

Why it stopped: The study was terminated after a pre-planned futility analyses showed an insufficient level of efficacy in the study population to warrant continuation.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01621243
Sponsor's protocol ID
M402-103
Status last verified
Jan 2017
First submitted
22 May 2012
Last updated
29 Aug 2018
Results posted
No
Data monitoring committee
No

Publications

  • O'Reilly EM, Barone D, Mahalingam D, Bekaii-Saab T, Shao SH, Wolf J, Rosano M, Krause S, Richards DA, Yu KH, Roach JM, Flaherty KT, Ryan DP. Randomised phase II trial of gemcitabine and nab-paclitaxel with necuparanib or placebo in untreated metastatic pancreas ductal adenocarcinoma. Eur J Cancer. 2020 Jun;132:112-121. doi: 10.1016/j.ejca.2020.03.005. Epub 2020 Apr 28.

    PubMed 32361265

  • O'Reilly EM, Roach J, Miller P, Yu KH, Tjan C, Rosano M, Krause S, Avery W, Wolf J, Flaherty K, Nix D, Ryan DP. Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of Necuparanib Combined with Nab-Paclitaxel and Gemcitabine in Patients with Metastatic Pancreatic Cancer: Phase I Results. Oncologist. 2017 Dec;22(12):1429-e139. doi: 10.1634/theoncologist.2017-0472. Epub 2017 Nov 20.

    PubMed 29158367

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing nab-paclitaxel, gemcitabine and Necuparanib in people with Metastatic Pancreatic Cancer, run by Momenta Pharmaceuticals, Inc. at 37 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated after a pre-planned futility analyses showed an insufficient level of efficacy in the study population to warrant continuation.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Safety (time frame: Part A: Baseline to 28 days after first-dose and end of study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01621243, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.

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