QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer

NantCell

Status and phase: Completed; Phase 2; Phase 1

Conditions: Metastatic Pancreatic Cancer; Adenocarcinoma of the Pancreas; Pancreatic Cancer

Treatments: Drug: AMG 479; Other: Placebo; Drug: AMG 655

Study type: Interventional

Funder types: Industry

Identifiers

NCT00630552

20060323

QUILT-2.019 (Other Identifier)

Details and patient eligibility

About

This is a multi-center, 2-part study of AMG 655, AMG 479 or AMG 655-placebo plus gemcitabine as first-line treatment of subjects with metastatic pancreatic cancer. Part 1 is an open-label, dose-escalation phase 1b segment to determine the safety, tolerability and maximum tolerated dose of AMG 655 in combination with gemcitabine. Enrollment into part 1 of the study has been completed. Part 2 is a randomized, placebo-controlled phase 2 segment to estimate the efficacy as assessed by 6 month survival of AMG 655, AMG 479, or AMG 655-placebo in combination with gemcitabine. The phase 2 segment that will commence after dose selection in part 1. In part 2, subjects will be randomized 1:1:1 to AMG 655, AMG 479, or placebo in combination with gemcitabine.

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Untreated metastatic adenocarcinoma of the pancreas (AJCC Stage IV)
• Subjects with unresectable pancreatic cancer who have had surgery are eligible if fully recovered and greater than 30 days have elapsed since the surgery.

Subjects with a history of pancreatoduodenectomy are eligible provided that there is radiographically documented disease recurrence.

• Men or women ≥ 18 years of age
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
• Adequate hematologic, hepatic, renal and coagulation function
• Amylase and lipase ≤ 2.0 x ULN
• Adequately controlled type 1 or 2 diabetic subjects

Exclusion criteria

• Islet cell, acinar cell carcinoma, non-adenocarcinoma (eg, lymphoma, sarcoma, etc), adenocarcinoma originated from biliary tree or cystadenocarcinoma
• Known central nervous system metastases
• Uncontrolled cardiac disease or any other co-morbid disease that would increase the risk of toxicity
• Adjuvant chemotherapy or chemoradiotherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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138 participants in 5 patient groups, including a placebo group

Phase 1b AMG 655 3mg/kg

Experimental group

Description:

Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.

Treatment:

Drug: AMG 655

Phase 1b AMG 655 10mg/kg

Experimental group

Description:

Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.

Treatment:

Drug: AMG 655

Phase 2 AMG 655

Experimental group

Description:

Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion.

Treatment:

Drug: AMG 655

Phase 2 AMG 479

Experimental group

Description:

Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.

Treatment:

Drug: AMG 479

Phase 2 AMG 655-placebo

Placebo Comparator group

Description:

Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.

Treatment:

Other: Placebo