A Phase 1b/2 Study of OMP-59R5 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer (ALPINE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by OncoMed Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01647828
First received: July 11, 2012
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

The study consists of a Phase1b lead-in portion to determine the maximum tolerated dose (MTD) of OMP-59R5 in combination with nab-paclitaxel and gemcitabine followed by a Phase 2, multicenter, randomized, placebo-controlled portion to evaluate the efficacy and safety of OMP-59R5 in combination with nab-paclitaxel and gemcitabine in subjects with previously untreated stage IV pancreatic cancer.


Condition Intervention Phase
Stage IV Pancreatic Cancer
Drug: OMP-59R5
Drug: Gemcitabine
Drug: Placebo
Drug: Nab-Paclitaxel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1b/2 Study of OMP-59R5 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by OncoMed Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Dose limiting toxicities (DLT) of OMP-59R5 in combination with nab-paclitaxel and gemcitabine [ Time Frame: Subjects will be treated and observed for DLT through the end of the first cycle (28 days) ] [ Designated as safety issue: Yes ]
    The maximum tolerated dose (MTD) will be determined in patients treated with OMP-59R5 in combination with nab-paclitaxel and gemcitabine

  • Progression-free survival (PFS) [ Time Frame: Number of days from randomization until death or disease progression, assessed up to 22 months ] [ Designated as safety issue: No ]
    To determine the clinical benefit, as measured by progression free survival (PFS) of the addition of OMP-59R5 to nab-paclitaxel and gemcitabine in all subjects who are receiving first-line therapy for stage IV pancreatic cancer (Phase 2 portion)


Secondary Outcome Measures:
  • Pharmacokinetics (PK) of OMP-59R5 when given in combination with gemcitabine [ Time Frame: Up to 14 days after the first dose in Cycle 1, pre- and 5 minutes post- dose on Day 15 of Cycle 2, and Day 1 of every other cycle starting from Cycle 3, and up to 14 days after the last dose, assessed up to 24 months ] [ Designated as safety issue: No ]
    Apparent half life, AUC, clearance, volume of distribution

  • Overall survival (OS), 6 months OS [ Time Frame: throughout the study and every 3 months after treatment discontinuation, assessed over 24 months ] [ Designated as safety issue: No ]
    Study visits are scheduled to occur every 7 (± 2) days for the first 3 weeks of each 4-week cycle. Survival follow-up information and subsequent anti-cancer therapies will be collected every 3 months until death, loss to follow-up, or study termination by the sponsor.

  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: every week during the first 3 weeks of a 4 week cycle, assessed over 24 months ] [ Designated as safety issue: Yes ]
    Safety and tolerability of OMP-59R5 in combination with nab-paclitaxel and gemcitabine in subjects with stage IV pancreatic cancer (Phase 1b and 2 portions in subjects receiving OMP-59R5 nab-paclitaxel and with gemcitabine)

  • Overall response rate (ORR) [ Time Frame: Every 8 weeks assessed up to 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 154
Study Start Date: October 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OMP-59R5 plus Gemcitabine and Nab-Paclitaxel
OMP-59R5 plus Gemcitabine and Nab-Paclitaxel
Drug: OMP-59R5
OMP-59R5 administered intravenously
Other Name: OMP-59R5
Drug: Gemcitabine
administered intravenously
Other Name: Gemcitabine
Drug: Nab-Paclitaxel
administered intravenously
Other Name: Abraxane
Experimental: Gemcitabine and Nab-Paclitaxel plus Placebo
Gemcitabine and Nab-Paclitaxel plus Placebo
Drug: Gemcitabine
administered intravenously
Other Name: Gemcitabine
Drug: Placebo
administered IV
Other Name: Placebo
Drug: Nab-Paclitaxel
administered intravenously
Other Name: Abraxane

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must meet all of the following major inclusion criteria to be eligible for the study:

  1. 18 years of age or older
  2. Histologically or cytologically documented stage IV ductal adenocarcinoma of the pancreas.
  3. Performance Status (ECOG) 0 or 1
  4. FFPE tumor tissue from metastatic site(s
  5. Adequate organ function
  6. Written consent on an IRB/IEC-approved Informed Consent Form prior to any study-specific evaluation.
  7. For women of child-bearing potential, negative serum pregnancy test at screening and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration.
  8. Male subjects must be surgically sterile or must agree to use physician-approved contraception from 30 days prior to the first study drug administration to 30 days following the last study drug administration.

Exclusion Criteria:

Subjects who meet any of the following major exclusion criteria will not be eligible for participation in the study:

  1. Neuroendocrine tumors (i.e., carcinoid, islet cell cancer) of the pancreas.
  2. Known brain metastases.
  3. Prior therapy, including systemic therapy, surgical resection or radiation for newly diagnosed stage IV pancreatic cancer.
  4. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism).
  5. Any disorder that would significantly compromise protocol compliance.
  6. Prior non-pancreatic malignancy treated with chemotherapy. Prior malignancies treated with surgery and/or radiotherapy alone must be in remission ≥3 years. The following prior malignancies are allowable irrespective of when they occurred: in situ carcinoma of the cervix, in situ ductal breast cancer, low-grade local bladder cancer, and nonmelanotic skin cancer.
  7. Known human immunodeficiency virus (HIV) infection.
  8. Females who are pregnant or breastfeeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647828

Contacts
Contact: Jakob Dupont, MA, MD 650-995-8307 jakob.dupont@oncomed.com

Locations
United States, California
Ronald Reagan UCLA Medical Center, Drug Information Center, Department of Pharmaceutical Services Recruiting
Los Angeles, California, United States, 90095
Contact: Joel Hecht    310-829-5471    jrhecht@mednet.ucla.edu   
Contact: Jill Paroly    (310) 794-5517      
Principal Investigator: Joel Hecht, M.D.         
Regulatory Management Only: TRIO-US Central Administration Recruiting
Los Angeles, California, United States, 90095
Contact: Hugo Hool, MD    310-750-3300      
Contact: Meg Fender    (310) 750-3376      
Principal Investigator: Hugo Hool, MD         
Regulatory Management Only: TRIO-US Central Administration Recruiting
Los Angeles, California, United States, 90095
Contact: Omar Kayaleh    321-841-4066    omar.kayaleh@orhs.org   
Contact: Kristine Moore    (321) 841-7612      
Principal Investigator: Omar Kayaleh, MD         
Regulatory Management Only: TRIO-US Central Administration Recruiting
Los Angeles, California, United States, 90095
Contact: Andre Kiem Dian Liem, MD    562-590-0345    andrel@pacshoresoncology.com   
Contact: Victoria Lansang    (562) 590-0345 ext 239      
Principal Investigator: Andre Kiem Dian Liem, MD         
Regulatory Management Only: TRIO-US Central Administration Recruiting
Los Angeles, California, United States, 90095
Contact: David Park, MD    714-446-5900    david.park@stjoe.org   
Contact: Gayle Madden-Mathes    (714) 446-5804      
Principal Investigator: David Park, MD         
Regulatory Management Only: TRIO-US Central Administration Recruiting
Los Angeles, California, United States, 90095
Contact: Ravindranath Patel, MD    661-322-2206    rrpatel@cbccusa.com   
Contact: Joy Moss    (661) 862-7158      
Principal Investigator: Ravindranath Patel, MD         
United States, Colorado
Rocky Mountain Cancer Centers Recruiting
Denver, Colorado, United States, 80218
Contact: Jennifer Hege    303-285-5075    Jennifer.Hege@USONCOLOGY.COM   
Contact: , RN         
Principal Investigator: Allen L. Cohn, M.D.         
United States, Georgia
Northside Hospital, Inc. - GCS/Almex Recruiting
Atlanta, Georgia, United States, 30341
Contact: Mansoor N. Saleh,, MD    404-256-4777      
Contact: Tedra Hughes    (404) 256-4777 ext 9244      
Principal Investigator: Mansoor N. Saleh, MD         
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Mark Zalupski, MD    734-615-3969    zalupski@umich.edu   
Contact: Kevin Frank    (734) 647-9112      
Principal Investigator: Mark Zalupski, MD         
United States, Minnesota
Allina Health, Virginia Piper Cancer Institute Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Joseph Leach, MD    612-863-8716    Joseph.Leach@allina.com   
Contact: Jacquelyn Underhill    (612) 863-3929      
Principal Investigator: Joseph Leach, MD         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Andrea Wang-Gillam, MD, PhD    314-362-5740    awang@dom.wustl.edu   
Contact: Kimberly Lears    (314) 747-8085      
Principal Investigator: Andrea Wang-Gillam, MD, PhD         
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Eileen M O'Reilly, MD    646-888-4182    oreillye@mskcc.org   
Contact: Nikos Sophos    (646) 888-4303      
Principal Investigator: Eileen M O'Reilly, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: John Strickler, MD    919-684-8111    john.strickler@dm.duke.edu   
Contact: Anthony Amara    (919) 668-1861      
Principal Investigator: John Strickler, MD         
United States, Oklahoma
Peggy and Charles Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Shubham Pant, MD    405-271-4022 ext 48396    Shubham-pant@ouhsc.edu   
Contact: Melissa Yarbrough    (405) 271-8001 ext 48340      
Principal Investigator: Shubham Pant, MD         
United States, Oregon
Bend Memorial Clinic Recruiting
Bend, Oregon, United States, 97701
Contact: Christine Reed, CCRC    541-318-3137    creed@bmctotalcare.com   
Principal Investigator: William G Schmidt Jr, MD         
United States, South Carolina
Greenville Health System, Clinical Research Unit, Institute for Translational Oncology Research Recruiting
Greenville, South Carolina, United States, 29605
Contact: William Gluck, MD    864-522-3065    lgluck@gbs.org   
Contact: Jane McClain    (864) 455-378      
Principal Investigator: William Gluck, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Ainslie Rogers    615-524-4155    ainslie.rogers@scresearch.net   
Principal Investigator: Johanna Bendell, MD         
United States, Texas
South Texas Accelerated Research Thereapeutics, LLC (START) Recruiting
San Antonio, Texas, United States, 78229
Contact: Linda G Noe, RN,OCN,CRC    210-593-2574    Linda.Noe@stoh.com   
Contact: Glenda Chambers, BSN,RN,OCN,CCRC    210-593-5204    glenda.chambers@start.stoh.com   
Principal Investigator: Lon S Smith, MD         
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Vincent Picozzi, MD    206-341-1652    vincent.picozzi@vmmc.org   
Contact: Ann Chancellor    (206) 342-6549      
Principal Investigator: Vincent Picozzi, MD         
United States, Wisconsin
University of Wiscons in Hospi tal and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Noelle LoConte, MD    608-265-5883    ns3@medicine.wisc.edu   
Contact: Kathryn Sklenar    (608) 263-9912      
Principal Investigator: Noelle LoConte, MD         
Sponsors and Collaborators
OncoMed Pharmaceuticals, Inc.
Investigators
Principal Investigator: Eileen M O'Reilly, MD Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01647828     History of Changes
Other Study ID Numbers: 59R5-002
Study First Received: July 11, 2012
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by OncoMed Pharmaceuticals, Inc.:
Newly diagnosed Stage IV Pancreatic Cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 24, 2014