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 August 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: August 29, 2014
Last verified: August 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

  Show 23 Study Locations
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: August 29, 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 Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Gemcitabine
Paclitaxel
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 29, 2014