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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)

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ClinicalTrials.gov Identifier: NCT01647828
Recruitment Status : Completed
First Posted : July 24, 2012
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
OncoMed Pharmaceuticals, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Stage IV Pancreatic Cancer Drug: OMP-59R5 Drug: Gemcitabine Drug: Placebo Drug: Nab-Paclitaxel Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2012
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: OMP-59R5 plus Gemcitabine and Nab-Paclitaxel
OMP-59R5 plus Gemcitabine and Nab-Paclitaxel
 Drug: OMP-59R5
OMP-59R5 administered intravenously

Drug: Gemcitabine
administered intravenously

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

Drug: Placebo
administered IV

Drug: Nab-Paclitaxel
administered intravenously
Other Name: Abraxane


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    The maximum tolerated dose (MTD) will be determined in patients treated with OMP-59R5 in combination with nab-paclitaxel and gemcitabine

  2. Progression-free survival (PFS) [ Time Frame: Number of days from randomization until death or disease progression, assessed up to 22 months ]
    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 :
  1. 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 ]
    Apparent half life, AUC, clearance, volume of distribution

  2. Overall survival (OS), 6 months OS [ Time Frame: throughout the study and every 3 months after treatment discontinuation, assessed over 24 months ]
    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.

  3. 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 ]
    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)

  4. Overall response rate (ORR) [ Time Frame: Every 8 weeks assessed up to 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647828


Locations
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Sponsors and Collaborators
OncoMed Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Eileen M O'Reilly, MD Memorial Sloan Kettering Cancer Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01647828    
Other Study ID Numbers: 59R5-002
First Posted: July 24, 2012    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Keywords provided by OncoMed Pharmaceuticals, Inc.:
Newly diagnosed Stage IV Pancreatic Cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Gemcitabine
Paclitaxel
Digestive System Diseases
Endocrine System Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs