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

NCT01231347 | Completed Phase 3 Results DMC

• 3 other identifiers: 20060540GAMMAQUILT-2.014
• Study Type: interventional
• Target: 800
• Locations: 29 countries
• Sites: 140

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

Conditions

Adenocarcinoma of the Pancreas; Advanced Solid Tumors; Cancer; Cancer of Pancreas; Cancer of the Pancreas; Metastases; Metastatic Cancer; Metastatic Pancreatic Cancer; Pancreas Cancer; Pancreatic Cancer; Bone Metastases; Endocrine Cancer; Oncology; Oncology Patients; Solid Tumors; Advanced Malignancy

Keywords

pancreas; gemcitabine; metastatic; jaundice

Outcome Measures

Primary Outcomes (1)

• Determine if the Treatment of AMG 479 at 12 mg/kg and/or 20 mg/kg in Combination With Gemcitabine Improves Overall Survival as Compared With Placebo in Combination With Gemcitabine in Subjects With Metastatic Adenocarcinoma of the Pancreas

  The primary endpoint of the study was OS, defined as the time from randomization to death.

  From randomization up to 20 months

Study Arms (3)

Placebo + gemcitabine

PLACEBO COMPARATOR

Arm 1: AMG 479-placebo IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle

Drug: Placebo; Drug: gemcitabine

AMG 479 12 mg/kg dose + gemcitabine

EXPERIMENTAL

Arm 2: AMG 479 12 mg/kg IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle

Drug: AMG 479; Drug: gemcitabine

AMG 479 20 mg/kg + gemcitabine

EXPERIMENTAL

Arm 3: AMG 479 20 mg/kg IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle

Drug: AMG 479; Drug: gemcitabine

Interventions

AMG 479 DRUG

AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle

AMG 479 12 mg/kg dose + gemcitabine

Placebo DRUG

Placebo administered intravenously on days 1 and 15 of a 28 day cycle

Placebo + gemcitabine

gemcitabine DRUG

gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle

Also known as: Gemzar

AMG 479 12 mg/kg dose + gemcitabine; AMG 479 20 mg/kg + gemcitabine; Placebo + gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Untreated metastatic adenocarcinoma of the pancreas
• Adequate hematologic, renal and liver function
• Eastern Cooperative Oncology Group (ECOG) 0 or 1

You may not qualify if:

• Prior chemotherapy or radiotherapy for pancreatic cancer
• Central nervous system metastases
• External biliary drain

Sponsors & Collaborators

• NantCell, Inc.: lead
• Takeda: collaborator

Study Sites (152)

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Fullerton, California, 92835, United States

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La Jolla, California, 92093-0957, United States

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Los Angeles, California, 90095-1772, United States

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Los Angeles, California, 90095, United States

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Rancho Mirage, California, 92270, United States

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Redondo Beach, California, 90277, United States

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Santa Maria, California, 93454, United States

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Chicago, Illinois, 60637, United States

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Harvey, Illinois, 60426, United States

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Quincy, Illinois, 62301, United States

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Boston, Massachusetts, 02114, United States

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Boston, Massachusetts, 02215, United States

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Detroit, Michigan, 48201, United States

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Grand Rapids, Michigan, 49503, United States

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Durham, North Carolina, 27710, United States

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Bend, Oregon, 97701, United States

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Providence, Rhode Island, 02903, United States

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Providence, Rhode Island, 02906, United States

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Charleston, South Carolina, 29425, United States

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Knoxville, Tennessee, 37909, United States

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Fort Worth, Texas, 76177, United States

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Paris, Texas, 75460-5004, United States

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Abingdon, Virginia, 24211, United States

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Spokane Valley, Washington, 99216, United States

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Kogarah, New South Wales, 2217, Australia

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South Brisbane, Queensland, 4101, Australia

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Kurralta Park, South Australia, 5037, Australia

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Woodville South, South Australia, 5011, Australia

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Bentleigh East, Victoria, 3165, Australia

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Parkville, Victoria, 3050, Australia

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Innsbruck, 6020, Austria

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Salzburg, 5020, Austria

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Steyr, 4400, Austria

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Vienna, 1090, Austria

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Brussels, 1070, Belgium

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Charleroi, 6000, Belgium

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Edegem, 2650, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Libramont, 6800, Belgium

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Salvador, Estado de Bahia, 40050-410, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

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Sofia, 1527, Bulgaria

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Sofia, 1606, Bulgaria

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Sofia, 1756, Bulgaria

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Varna, 9010, Bulgaria

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Vancouver, British Columbia, V5Z 4E6, Canada

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Oshawa, Ontario, L1G 2B9, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Québec, Quebec, G1R 2J6, Canada

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Brno, 656 53, Czechia

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Brno, 656 91, Czechia

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Hradec Králové, 500 05, Czechia

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Olomouc, 775 20, Czechia

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Prague, 128 08, Czechia

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Prague, 150 06, Czechia

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Aalborg, 9000, Denmark

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Herlev, 2730, Denmark

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Odense, 5000, Denmark

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Lahti, 15850, Finland

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Tampere, 33521, Finland

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Turku, 20521, Finland

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Brest, 29609, France

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Clermont-Ferrand, 63003, France

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Pessac, 33604, France

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Berlin, 13353, Germany

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Dresden, 01307, Germany

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Halle, 06120, Germany

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Mainz, 55131, Germany

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Mannheim, 68167, Germany

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Marburg, 35043, Germany

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Villingen-Schwenningen, 78050, Germany

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Athens, 11527, Greece

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Heraklion, 71110, Greece

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Pátrai, 26500, Greece

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Thessaloniki, 56429, Greece

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Kowloon, Hong Kong

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Shatin, Hong Kong

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Tuenmen, Hong Kong

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Budapest, 1062, Hungary

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Budapest, 1097, Hungary

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Debrecen, 4012, Hungary

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Győr, 9023, Hungary

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Miskolc, 3526, Hungary

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Genova, 16132, Italy

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Messina, 98125, Italy

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Napoli, 80131, Italy

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Nagoya, Aichi-ken, 464-8681, Japan

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Kashiwa, Chiba, 277-8577, Japan

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Yokohama, Kanagawa, 241-0815, Japan

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Mitaka, Tokyo, 181-8611, Japan

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Tokyo, 104-0045, Japan

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Kaunas, 50009, Lithuania

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Vilnius, 08660, Lithuania

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Amsterdam, 1081 HV, Netherlands

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Eindhoven, 5623 EJ, Netherlands

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Groningen, 9713 GZ, Netherlands

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Leiden, 2333 ZA, Netherlands

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Gdansk, 80-952, Poland

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Konin, 62-500, Poland

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Lodz, 93-509, Poland

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Poznan, 61-485, Poland

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Warsaw, 02-097, Poland

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Warsaw, 04-125, Poland

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Warsaw, 04-141, Poland

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Barreiro, 2830-094, Portugal

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Lisbon, 1099-023, Portugal

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Lisbon, 1649-035, Portugal

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Porto, 4200-072, Portugal

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Porto, 4200-319, Portugal

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Bucharest, 022328, Romania

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Cluj-Napoca, 400015, Romania

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Sibiu, 550245, Romania

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Moscow, 115478, Russia

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Moscow, 119992, Russia

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Saint Petersburg, 191104, Russia

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Belgrade, 11000, Serbia

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Belgrade, 11080, Serbia

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Kamenitz, 21204, Serbia

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Bardejov, 085 01, Slovakia

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Bratislava, 833 10, Slovakia

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Košice, 041 91, Slovakia

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Nitra, 950 01, Slovakia

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Poprad, 058 01, Slovakia

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Ljubljana, 1000, Slovenia

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Ljubljana, 1525, Slovenia

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Seoul, 110-744, South Korea

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Seoul, 120-752, South Korea

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Seoul, 135-710, South Korea

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Seoul, 138-736, South Korea

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Seoul, 152-703, South Korea

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Santander, Cantabria, 39008, Spain

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Badalona, Cataluña, 08916, Spain

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Barcelona, Cataluña, 08035, Spain

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Barcelona, Cataluña, 08036, Spain

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Elche, Valencia, 03203, Spain

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Valencia, Valencia, 46010, Spain

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Madrid, 28034, Spain

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Madrid, 28050, Spain

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Eskilstuna, 631 88, Sweden

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Uppsala, 751 85, Sweden

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Basel, 4031, Switzerland

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Geneva, 1211, Switzerland

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Winterthur, 8401, Switzerland

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Taipei City, Taipei, 10002, Taiwan

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Belfast, BT9 7AB, United Kingdom

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Birmingham, B9 5SS, United Kingdom

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Cottingham, HU16 5JQ, United Kingdom

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Leicester, LE1 5WW, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Northampton, NN1 5BD, United Kingdom

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Related 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):921-927. doi: 10.1093/annonc/mdv027. Epub 2015 Jan 21.

  PMID: 25609246 BACKGROUND

Related Links

• AmgenTrials clinical trials website
• Related Info

MeSH Terms

Conditions

Neoplasms; Pancreatic Neoplasms; Neoplasm Metastasis; Endocrine Gland Neoplasms; Jaundice

Interventions

ganitumab; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperbilirubinemia; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Sandeep Bobby Reddy, Chief Medical Officer
• Organization: ImmunityBio

Bobby.Reddy@immunitybio.com

855-797-9277

Study Officials

• NantKWest Clinical Review Team

  ImmunityBio, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: November 1, 2010
• Study Start: April 7, 2011
• Primary Completion: December 12, 2012
• Study Completion: December 12, 2012
• Last Updated: July 16, 2024
• Results First Posted: July 16, 2024

Record last verified: 2024-06

Locations

BE (6); FR (3); AU (6); CA (5); SL (2); GR (4); HK (3); RU (3); DK (3); HU (5); LI (2); DE (7); CZ (6); KR (5); BR (2); PL (7); RO (3); GB (6); JP (5); US (24); SE (2); ES (8); IT (3); NL (4); BU (4); CH (3); TW (1); PT (5); FI (3)