Skip to main content
OpenTrials
Completed

NCT Number: NCT00630552

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adenocarcinoma of the Pancreas Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Insulin-Like Growth Factor I, Resistance To Metastatic Pancreatic Cancer Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Site, Alhambra, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Other

Inactive dummy of AMG 655.

AMG 479

Drug

AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).

AMG 655

Drug

AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).

Primary outcomes

  1. Number of Participants With Dose Limiting Toxicities (DLTs; Phase 1b Portion Only)

    Time frame: 28 days

    The incidence of adverse events and clinical laboratory abnormalities defined as DLTs. A DLT was defined as any grade 3 or higher hematologic or non-hematologic toxicity related to any study treatment.

  2. Six Month Overall Survival Rate (Phase 2 Portion Only)

    Time frame: 6 months

    The proportion of subjects alive at 6 months

Secondary outcomes

  1. Objective Response Rate

    Time frame: From start of study treatment through up to 36 months

    Objective response was defined as a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors [RECIST] and was determined only for subjects with measurable disease at baseline. Per RECIST: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  2. Progression-free Survival (PFS)

    Time frame: From start of study treatment through up to 36 months

    PFS was defined as the time from study day 1 (phase 1b portion) or randomization (phase 2 portion) to the first observation of disease progression per investigator review (as classified by modified RECIST or clinical progression, whichever occurred first) or death due to any cause, or censoring. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.

  3. Overall Survival

    Time frame: From start of study treatment through up to 36 months

    Overall survival was defined as the time from study day 1 (phase 1b portion) or randomization (phase 2 portion) to death for any cause.

  4. Number of Subjects With an Adverse Event

    Time frame: From start of study treatment through up to 44 weeks

    Graded Using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE) Version 3.0

  5. Pharmacokinetics of AMG 655, Ganitumab, and Gemcitabine

    Time frame: From start of study treatment through up to 48 weeks

    PK parameter of Cmax for AMG 655 (phase 1b and phase 2 portions) - pg 266, ganitumab (phase 2 portion only) - pg 270 , and gemcitabine (phase 1b portion only - pg 272) PK parameters

  6. Dose Intensity of Gemcitabine (Phase 2 Portion Only)

    Time frame: From start of study treatment through up to 40 weeks

    Average Dose intensity of gemcitabine when combined with AMG 655, placebo or AMG 479

  7. Duration of Response

    Time frame: From objective response through up to 36 months

    Duration of response was the time from the first observation of an objective response to the subsequent time of disease progression (per modified RECIST or clinical progression, whichever came first) or death due to any cause. Objective response = a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors [RECIST]. Per RECIST: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  8. Incidence of Antibody Formation

    Time frame: From start of treatment up to 40 weeks

    The incidence of antibody formation of anti-AMG 655 (phase 1b and phase 2 portions) or anti- ganitumab (phase 2 portion only)

Sponsors and collaborators

Lead sponsor

NantCell, Inc.

Industry

Registry information

Official study title

A Phase 1b/2 Study to Evaluate the Safety and Efficacy of AMG 655 or AMG 479 in Combination With Gemcitabine as First-Line Therapy for Metastatic Pancreatic Cancer

Important dates

Study start
2007
Primary completion
2010
Study completion
2012
First posted
Mar 7, 2008
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.