Clinical trialPhase 2Terminated
Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of AMG 479 or Placebo in Combination With Gemcitabine as First-line Therapy for Locally Advanced Unresectable Adenocarcinoma of the Pancreas
- Outcome
- Stopped earlyNCT01318642: Planned independent DMC Interim review: ended for futility (Efficacy or futility)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- 31 May 2012
- Expected end
- 3 December 2012
- Enrollment
- 10 participants
- Sites
- 35
- Primary outcomes
- The Primary Endpoint is Progression-free Survival (PFS) as Defined as the Time From Randomization to Progression (Per RECIST v1.1) or Death.
- Sponsor
- Industry
- Results posted
- 2024-11-08
- Last update
- 8 November 2024
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Brief summary public domain (ClinicalTrials.gov)
This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects will be randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo. Randomization will be stratified by ECOG (0 or 1). Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of every 28 day cycle. Treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.
Detailed description public domain (ClinicalTrials.gov)
This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects will be randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo. Randomization will be stratified by ECOG (0 or 1). Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of every 28 day cycle. Treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
The Primary Endpoint is Progression-free Survival (PFS) as Defined as the Time From Randomization to Progression (Per RECIST v1.1) or Death. [From randomization to the date of either disease progression or death, up to 181 days progression or death]. Median, Months (95% Confidence Interval). Placebo + Gemcitabine (n=5): NA (NA to NA) [lack of participants with events]; AMG 479 20 mg/kg + Gemcitabine (n=3): NA (NA to NA) [lack of participants with events].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [Up to 181 days]. Median, Months (95% Confidence Interval). Placebo + Gemcitabine (n=5): NA (NA to NA) [lack of participants with events]; AMG 479 20 mg/kg + Gemcitabine (n=3): NA (NA to NA) [lack of participants with events].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Adverse Events [Up to 4 months]. Count Of Participants, Participants. Placebo + Gemcitabine (n=5): 5; AMG 479 20 mg/kg + Gemcitabine (n=3): 3.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression Free Survival Rate and Overall Survival Rate at at 3 and 6 Months, Objective Response Rate, Disease Control Rate [Up to 181 days]. Count Of Participants, Participants. Progression Free Survival Rate at 3 months: Placebo + Gemcitabine (n=5): 2; AMG 479 20 mg/kg + Gemcitabine (n=3): 0. Progression Free Survival Rate at 6 months: Placebo + Gemcitabine (n=5): 2; AMG 479 20 mg/kg + Gemcitabine (n=3): 0. Overall Survival Rate at 3 months: Placebo + Gemcitabine (n=5): 5; AMG 479 20 mg/kg + Gemcitabine (n=3): 3. Overall Survival Rate at 6 months: Placebo + Gemcitabine (n=5): 4; AMG 479 20 mg/kg + Gemcitabine (n=3): 3. Objective Response Rate: Placebo + Gemcitabine (n=5): NA [lack of participants with events (e.g. PR, CR)]; AMG 479 20 mg/kg + Gemcitabine (n=3): NA [lack of participants with events (e.g. PR, CR)]. Disease Control Rate: Placebo + Gemcitabine (n=5): NA [lack of participants with events (e.g. PR, CR, SD)]; AMG 479 20 mg/kg + Gemcitabine (n=3): NA [lack of participants with events (e.g. PR, CR, SD)].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Duration of Response [Up to 181 days]. Mean, Months (Full Range). Placebo + Gemcitabine (n=5): NA (NA to NA) [lack of participants with events (eg CR or PR)]; AMG 479 20 mg/kg + Gemcitabine (n=3): NA (NA to NA) [lack of participants with events (eg CR or PR)].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Anti-AMG 479 Antibodies [Up to 181 days]. Count Of Participants, Participants. Placebo + Gemcitabine (n=5): 0; AMG 479 20 mg/kg + Gemcitabine (n=3): 0.