Clinical trialPhase 1 / Phase 2Completed
A Phase 1b/2 Study of OMP-59R5 (Tarextumab) 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
- Outcome
- Outcome unknown
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- October 2012
- Expected end
- April 2016
- Enrollment
- 217 participants
- Sites
- 26
- Primary outcomes
- Phase Ib: Number of Participants With Dose-limiting Toxicities (DLT); Phase 2: Overall Survival (ITT Population); Phase 2: Median OS by Notch 3 Percentile (ITT Population)
- Sponsor
- Industry
- Results posted
- 2023-02-15
- Last update
- 15 February 2023
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Brief summary public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Phase Ib: Number of Participants With Dose-limiting Toxicities (DLT) [Up to 1 year in absence of unacceptable toxicity or disease progression.]. Count Of Participants, Participants. P1B: OMP-59R5 2.5 mg/kg + Gem (n=4): 0; P1B: OMP-59R5 5 mg/kg + Gem (n=4): 0; P1B: OMP-59R5 5 mg/kg + Nab-P + Gem (n=4): 0; P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem (n=6): 0; P1B: OMP-59R5 10 mg/kg + Nab-P + Gem (n=6): 0; P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem (n=3): 0; P1B: OMP-59R5 15 mg/kg + Nab-P + Gem (n=10): 1.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Phase 2: Overall Survival (ITT Population) [Up to 1 year in absence of unacceptable toxicity or disease progression.]. Number, participants. Number of subjects who died: P2: Placebo + Nab-P + Gem (n=88): 60; P2: OMP-59R5 15 mg/kg + Nab-P + Gem (n=89): 71. Number of subjects who did not die: P2: Placebo + Nab-P + Gem (n=88): 28; P2: OMP-59R5 15 mg/kg + Nab-P + Gem (n=89): 18.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Phase 2: Median OS by Notch 3 Percentile (ITT Population) [Up to 1 year in absence of unacceptable toxicity or disease progression.]. Median, Days (95% Confidence Interval). Notch 3 ≥ 75th percentile: P2: Placebo + Nab-P + Gem (n=55): 187.5 (95.0 to NA) [Upper 95% CI was not reached]; P2: OMP-59R5 15 mg/kg + Nab-P + Gem (n=55): 228.0 (101.0 to 453.0). Notch 3 ≥ 50th percentile: P2: Placebo + Nab-P + Gem (n=55): 220.5 (135.0 to 329.0); P2: OMP-59R5 15 mg/kg + Nab-P + Gem (n=55): 151.0 (101.0 to 258.0). Notch 3 ≥ 25th percentile: P2: Placebo + Nab-P + Gem (n=55): 206.0 (146.0 to 312.0); P2: OMP-59R5 15 mg/kg + Nab-P + Gem (n=55): 165.0 (123.0 to 252.0).