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

NantCell

Status and phase: Completed; Phase 3

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

Treatments: Drug: Placebo; Drug: gemcitabine; Drug: AMG 479

Study type: Interventional

Funder types: Industry

Identifiers

NCT01231347

GAMMA

20060540

QUILT-2.014 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 800 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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800 participants in 3 patient groups, including a placebo group

Placebo + gemcitabine

Placebo Comparator group

Description:

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

Treatment:

Drug: gemcitabine

Drug: Placebo

AMG 479 12 mg/kg dose + gemcitabine

Experimental group

Description:

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

Treatment:

Drug: AMG 479

Drug: gemcitabine

Drug: AMG 479

AMG 479 20 mg/kg + gemcitabine

Experimental group

Description:

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

Treatment:

Drug: AMG 479

Drug: gemcitabine

Drug: AMG 479