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
Overview
- Phase
- Phase 2
- Intervention
- Gemcitabine
- Conditions
- Adenocarcinoma of the Pancreas
- Sponsor
- NantBioScience, Inc.
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- The Primary Endpoint is Progression-free Survival (PFS) as Defined as the Time From Randomization to Progression (Per RECIST v1.1) or Death.
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must have histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas that is unresectable, per institutional practice
- •Radiologically measurable and/or non-measurable disease as defined by RECIST version 1.1
- •Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- •Men or women \>/= 18 years of age
- •Adequate organ function
Exclusion Criteria
- •Early (stage I) or metastatic (stage IV) disease
- •Islet cell, acinar cell carcinoma, non-adenocarcinoma, (eg, lymphoma, sarcoma, etc), adenocarcinoma originating from biliary tree or cystadenocarcinoma
- •External biliary drain
- •Currently treated or previously treated with biologic, small molecule, immunotherapy, chemotherapy (ie, including gemcitabine), or other agents for pancreatic cancer
- •Currently treated or previously treated with radiotherapy, or chemoradiotherapy for pancreatic cancer
Arms & Interventions
Placebo + Gemcitabine
Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle
Intervention: Gemcitabine
Placebo + Gemcitabine
Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle
Intervention: Placebo
AMG 479 20 mg/kg + Gemcitabine
ARM 1: AMG 479 20mg/kg IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle.
Intervention: Gemcitabine
AMG 479 20 mg/kg + Gemcitabine
ARM 1: AMG 479 20mg/kg IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle.
Intervention: AMG 479
Outcomes
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.
Time Frame: From randomization to the date of either disease progression or death, up to 181 days progression or death
The time from randomization to progression (per RECIST version 1.1) or death from any cause. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
Secondary Outcomes
- Overall Survival(Up to 181 days)
- Number of Participants With Adverse Events(Up to 4 months)
- Progression Free Survival Rate and Overall Survival Rate at at 3 and 6 Months, Objective Response Rate, Disease Control Rate(Up to 181 days)
- Duration of Response(Up to 181 days)
- Number of Participants With Anti-AMG 479 Antibodies(Up to 181 days)