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NCT01231347 Clinical Trial

QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas

Cancer Clinical Trial

— GAMMA  

Official title:
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination With Gemcitabine as First Line Therapy for Metastatic Adenocarcinoma of the Pancreas

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01231347
Other study ID # 20060540
Secondary ID 20060540GAMMAQUI
Status Terminated
Phase Phase 3
First received October 14, 2010
Last updated October 26, 2016
Start date April 2011
Est. completion date December 2012

Study information
Verified date October 2016
Source NantCell, Inc.
Contact n/a
Is FDA regulated No
Health authority Canada: Health CanadaUnited States: Dana Farber Cancer Institute IRBUnited States: Food and Drug AdministrationUnited States: Schulman Associates IRBUnited States: US Oncology Institutional Review BoardUnited States: Western Institutional Review BoardBelgium: Centre Hospitalier de l'Ardenne comité d'éthiqueBrazil: Ministry of HealthGreece: National Ethics CommitteeJapan: Pharmaceuticals and Medical Devices Evaluation CenterUnited State: Western Institutional Review BoardBelgium: Commissie Medische Ethiek van de Universitaire Ziekenhuizen KULeuven
Study type Interventional

Clinical Trial Summary

AMG 479 is an investigational fully human monoclonal antibody that targets type 1 insulin-like growth factor receptor (IGF-1R). Signaling through IGF-1R plays an important role in the regulation of cell growth and survival.

Gemcitabine is administered on days 1, 8 and 15 of a 28 day cycle, AMG 479 or placebo is administered on days 1 and 15 of the 28 day cycle, both are administered intravenously.

The primary purpose of the study is to determine if AMG 479 and gemcitabine improves overall survival as compared to placebo and gemcitabine.

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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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Intervention

Drug:
• AMG 479
AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle
• Placebo
Placebo administered intravenously on days 1 and 15 of a 28 day cycle
• AMG 479
AMG 479 20mg/kg administered intravenously on days 1 and 15 of a 28 day cycle
• gemcitabine
gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
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Sponsors (2)
Lead Sponsor Collaborator
NantCell, Inc. Takeda

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Italy,  Japan,  Korea, Republic of,  Lithuania,  Netherlands,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  Slovenia,  Spain,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

References & Publications (1)

Fuchs CS, Azevedo S, Okusaka T, Van Laethem JL, Lipton LR, Riess H, Szczylik C, Moore MJ, Peeters M, Bodoky G, Ikeda M, Melichar B, Nemecek R, Ohkawa S, Swieboda-Sadlej A, Tjulandin SA, Van Cutsem E, Loberg R, Haddad V, Gansert JL, Bach BA, Carrato A. A phase 3 randomized, double-blind, placebo-controlled trial of ganitumab or placebo in combination with gemcitabine as first-line therapy for metastatic adenocarcinoma of the pancreas: the GAMMA trial. Ann Oncol. 2015 May;26(5):921-7. doi: 10.1093/annonc/mdv027. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary To determine if AMG 479 in combination with gemcitabine improves overall survival as compared with placebo in combination with gemcitabine in subjects with metastatic adenocarcinoma of the pancreas After 825 subjects randomized + 24 months No
Secondary Progression free survival After 825 subjects randomized + 24 months No
Secondary Objective response rate After 825 subjects randomized + 24 months No
Secondary Time to disease progression After 825 subjects randomized + 24 months No
Secondary Disease control rate After 825 subjects randomized + 24 months No
Secondary Number of subjects with adverse events After 825 subjects randomized + 24 months Yes
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