Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas

NantBioscience

Status and phase: Terminated; Phase 2

Conditions: Locally Advanced; Unresectable; Adenocarcinoma of the Pancreas

Treatments: Drug: Gemcitabine; Drug: Placebo; Drug: AMG 479

Study type: Interventional

Funder types: Industry

Identifiers

NCT01318642

20080261

2010-023978-39 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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10 participants in 2 patient groups

Placebo + Gemcitabine

Active Comparator group

Description:

Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle

Treatment:

Drug: Placebo

Drug: Gemcitabine

AMG 479 20 mg/kg + Gemcitabine

Experimental group

Description:

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.

Treatment:

Drug: AMG 479

Drug: Gemcitabine