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

July 11, 2012
July 14, 2014
October 2012
January 2015   (final data collection date for primary outcome measure)
  • 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)
  • Dose limiting toxicities (DLT) of OMP-59R5 in combination with gemcitabine [ Time Frame: Subjects will be treated and observed for DLT through the end of the first cycle (28 days), assessed up to 7 months ] [ Designated as safety issue: Yes ]
    The maximum tolerated dose (MTD) will be determined in patients treated with OMP-59R5 in combination with gemcitabine on Days 1, 8 and 15 of every 28-day cycle
  • Progression-free survival (PFS) [ Time Frame: every 8 weeks till disease progression or start of new anti-cancer therapy, assessed up to 22 months ] [ Designated as safety issue: No ]
    If subjects experience unacceptable toxicities clearly related to one of the two drugs, they may continue the other drug alone until disease progression, or withdrawal of consent or unacceptable toxicity. Subjects who are discontinued from OMP-59R5 treatment will enter Follow-up period, be followed for survival and any subsequent anti-cancer therapies. Additionally, subjects who discontinue OMP-59R5 treatment for any reason other than disease progression will be followed with tumor assessment every 8 weeks/56 days
Complete list of historical versions of study NCT01647828 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 gemcitabine in subjects with stage IV pancreatic cancer (Phase 1b and 2 portions in subjects receiving OMP-59R5 with gemcitabine)
  • Overall response rate (ORR) [ Time Frame: Every 8 weeks assessed up to 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Phase 1b/2 Study of OMP-59R5 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer
A Phase 1b/2 Study of OMP-59R5 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Stage IV Pancreatic Cancer
  • Drug: OMP-59R5
    OMP-59R5 administered intravenously
    Other Name: OMP-59R5
  • Drug: Gemcitabine
    administered intravenously
    Other Name: Gemcitabine
  • Drug: Placebo
    administered IV
    Other Name: Placebo
  • Drug: Nab-Paclitaxel
    administered intravenously
    Other Name: Abraxane
  • Experimental: OMP-59R5 plus Gemcitabine and Nab-Paclitaxel
    OMP-59R5 plus Gemcitabine and Nab-Paclitaxel
    Interventions:
    • Drug: OMP-59R5
    • Drug: Gemcitabine
    • Drug: Nab-Paclitaxel
  • Experimental: Gemcitabine and Nab-Paclitaxel plus Placebo
    Gemcitabine and Nab-Paclitaxel plus Placebo
    Interventions:
    • Drug: Gemcitabine
    • Drug: Placebo
    • Drug: Nab-Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
154
September 2016
January 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact: Jakob Dupont, MA, MD 650-995-8307 jakob.dupont@oncomed.com
United States
 
NCT01647828
59R5-002
Yes
OncoMed Pharmaceuticals, Inc.
OncoMed Pharmaceuticals, Inc.
Not Provided
Principal Investigator: Eileen M O'Reilly, MD Memorial Sloan-Kettering Cancer Center
OncoMed Pharmaceuticals, Inc.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP