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

NCT00630552 | Completed Phase 1 Results

• 2 other identifiers: 20060323QUILT-2.019
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 44

Brief Summary

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.

Conditions

Adenocarcinoma of the Pancreas; Metastatic Pancreatic Cancer; Pancreatic Cancer

Keywords

AMG 479; Gemcitabine; TR-2; IGF-1R; AMG 655; Pancreatic cancer; Adenocarcinoma of the Pancreas; Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

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

  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.

  28 days

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

  The proportion of subjects alive at 6 months

  6 months

Secondary Outcomes (8)

• Objective Response Rate

  From start of study treatment through up to 36 months

• Progression-free Survival (PFS)

  From start of study treatment through up to 36 months

• Overall Survival

  From start of study treatment through up to 36 months

• Number of Subjects With an Adverse Event

  From start of study treatment through up to 44 weeks

• Pharmacokinetics of AMG 655, Ganitumab, and Gemcitabine

  From start of study treatment through up to 48 weeks

Study Arms (5)

Phase 1b AMG 655 3mg/kg

EXPERIMENTAL

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

Drug: AMG 655

Phase 1b AMG 655 10mg/kg

EXPERIMENTAL

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

Drug: AMG 655

Phase 2 AMG 655

EXPERIMENTAL

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.

Drug: AMG 655

Phase 2 AMG 479

EXPERIMENTAL

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.

Drug: AMG 479

Phase 2 AMG 655-placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Placebo OTHER

Inactive dummy of AMG 655.

Phase 2 AMG 655-placebo

AMG 479 DRUG

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

Phase 2 AMG 479

AMG 655 DRUG

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

Phase 1b AMG 655 10mg/kg; Phase 1b AMG 655 3mg/kg; Phase 2 AMG 655

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 (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

You may not qualify if:

• 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

Sponsors & Collaborators

• NantCell, Inc.: lead

Study Sites (44)

Research Site

Alhambra, California, 91801, United States

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Bakersfield, California, 93309, United States

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Fullerton, California, 92835, United States

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La Jolla, California, 92093, United States

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Long Beach, California, 90813, United States

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Los Angeles, California, 90095, United States

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Northridge, California, 91328, United States

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Oxnard, California, 93030, 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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San Francisco, California, 94115, United States

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Santa Maria, California, 93454, United States

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Santa Monica, California, 90403, United States

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Miami, Florida, 33136, United States

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Orlando, Florida, 32804, United States

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Atlanta, Georgia, 30309, United States

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Atlanta, Georgia, 30341, United States

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Marietta, Georgia, 30060, United States

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Chicago, Illinois, 60637, United States

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Harvey, Illinois, 60426, United States

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Baltimore, Maryland, 21204, United States

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Westminster, Maryland, 21157, United States

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Boston, Massachusetts, 02114, United States

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Boston, Massachusetts, 02115, United States

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St Louis, Missouri, 63141, United States

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Henderson, Nevada, 89052, United States

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Albany, New York, 12206, United States

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New York, New York, 10016, United States

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Durham, North Carolina, 27710, United States

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Hickory, North Carolina, 28602, United States

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Columbus, Ohio, 43210, United States

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Eugene, Oregon, 97401, United States

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Philadelphia, Pennsylvania, 19106, United States

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Pittsburgh, Pennsylvania, 15261, United States

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Providence, Rhode Island, 02903, United States

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Greenville, South Carolina, 29615, United States

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Austin, Texas, 78705, United States

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Austin, Texas, 78731, United States

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Austin, Texas, 78745, United States

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Dallas, Texas, 75246, United States

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Round Rock, Texas, 78681, United States

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Tyler, Texas, 75702, United States

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Tacoma, Washington, 98405, United States

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Yakima, Washington, 98902, United States

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Related Publications (5)

• Cella D, Butt Z, Kindler HL, Fuchs CS, Bray S, Barlev A, Oglesby A. Validity of the FACT Hepatobiliary (FACT-Hep) questionnaire for assessing disease-related symptoms and health-related quality of life in patients with metastatic pancreatic cancer. Qual Life Res. 2013 Jun;22(5):1105-12. doi: 10.1007/s11136-012-0217-4. Epub 2012 Jun 8.

  PMID: 22678353 BACKGROUND

• Kindler HL, Richards DA, Garbo LE, Garon EB, Stephenson JJ Jr, Rocha-Lima CM, Safran H, Chan D, Kocs DM, Galimi F, McGreivy J, Bray SL, Hei Y, Feigal EG, Loh E, Fuchs CS. A randomized, placebo-controlled phase 2 study of ganitumab (AMG 479) or conatumumab (AMG 655) in combination with gemcitabine in patients with metastatic pancreatic cancer. Ann Oncol. 2012 Nov;23(11):2834-2842. doi: 10.1093/annonc/mds142. Epub 2012 Jun 13.

  PMID: 22700995 BACKGROUND

• Lu, JF.Exposure-response analysis to facilitate phase 3 dose selection for Ganitumumab (AMG 479) in combination with Gemcitabine to treat metastatic pancreatic cancer.Journal-000728;

  BACKGROUND

• McCaffery I, Tudor Y, Deng H, Tang R, Suzuki S, Badola S, Kindler HL, Fuchs CS, Loh E, Patterson SD, Chen L, Gansert JL. Putative predictive biomarkers of survival in patients with metastatic pancreatic adenocarcinoma treated with gemcitabine and ganitumab, an IGF1R inhibitor. Clin Cancer Res. 2013 Aug 1;19(15):4282-9. doi: 10.1158/1078-0432.CCR-12-1840. Epub 2013 Jun 5.

  PMID: 23741071 BACKGROUND

• TBD.Validation of the FACT-hepatobiliary questionnaire in metastatic pancreatic cancer population.Journal-004521;

  BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Pancreatic Neoplasms; Insulin-Like Growth Factor I, Resistance To

Interventions

ganitumab; conatumumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

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

Bobby.Reddy@immunitybio.com

855-797-9277

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 7, 2008
• Study Start: June 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: April 1, 2012
• Last Updated: October 17, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-10

Locations

US (44)