Clinical trial NCT00819169: QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors
Official title: A Phase 1b/2 Open Label, Dose Escalation Study of AMG 655 in Combination With AMG 479 in Subjects With Advanced, Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Colorectal Cancer
Locally Advanced
Metastatic Cancer
Non-Small Cell Lung Cancer
Ovarian Cancer
Pancreatic Cancer
Sarcoma
Solid Tumors
Keywords: AMG 655
AMG 479
Apoptosis
Monoclonal Antibody
Tumor Necrosis Factor
Insulin-like Growth Factor
Lead sponsor: NantCell, Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-08
Enrollment: 89
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, 2-part phase 1b/2 study of AMG 655 in combination with AMG 479 to be conducted in the United States and Spain.

Part 1 is a dose escalation segment to identify a dose of AMG 655 in combination with AMG 479 that is safe and tolerable.

Part 2 will evaluate the safety and estimate the efficacy of AMG 655 at the dose selected in Part 1 in combination with AMG 479 for the treatment of patients with advanced NSCLC (non-squamous histology; squamous histology), CRC, pancreatic cancer, ovarian cancer, and sarcoma.


Eligibility criteria: Inclusion Criteria:

* Part 1: Histologically or cytologically confirmed, locally advanced or metastatic, treatment-refractory solid tumors
* Part 2: Histologically or cytologically confirmed, locally advanced or metastatic: NSCLC (squamous or non-squamous cell carcinoma; up to 2 prior treatment regimens), Colorectal Cancer (up to 2 prior treatment regimens), Pancreatic Cancer (up to 1 prior treatment regimen), Ovarian cancer (up to 2 prior treatment regimens), or Sarcoma (up to 2 prior treatment regimens), according to cohort availability
* Eastern Cooperative Group (ECOG performance status of 0 or 1
* Women or men ≥16 years of age
* Adequate hematology, renal, hepatic, coagulation and glycemic function.

Exclusion Criteria:

* Presence of uncontrolled central nervous system (CNS) disease
* Systemic chemotherapy, hormonal therapy, immunotherapy, experimental or approved anticancer proteins/antibodies therapy ≤28 days before enrollment.
* Prior treatment with death receptor agonists (including but not limited to rhApo2L/TRAIL \[AMG951\], apomab, mapatumumab, lexatumumab, CS-1008)
* Prior treatment with IGF receptor antagonists (including but not limited to CP-751, 871, MK0646, AVE1642 or IMC-A12)

Primary outcomes:
measure: Number of Participants With Dose-limiting Toxicities
timeFrame: Time from first dose up to 24 months
measure: Objective Response Rate
timeFrame: Time from first dose up to 24 months
Secondary outcomes:
measure: Progression Free Survival
timeFrame: Time from first dose up to 24 months
measure: To Evaluate Anti-AMG 655 Antibody Formation and Anti-AMG 479 Antibody Formation
timeFrame: Time from first dose up to 24 months
measure: To Evaluate the Concentration Level of AMG 655
timeFrame: Cycle 1 Day 1 end of infusion; Cycle 3 Day 1 end of infusion (each cycle is 28 days, each infusion is up to 1 hour)
measure: To Evaluate the Concentration Level of AMG 479
timeFrame: Cycle 1 Day 1 end of infusion; Cycle 3 Day 1 end of infusion (each cycle is 28 days, each infusion is up to 1 hour)
measure: Time to Response
timeFrame: Time from first dose up to 24 months
measure: Duration of Response
timeFrame: Time from objective response to 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Chawla S, Tabernero, J, Kindler, H., Reckamp, K., Chiorean, E., Azad, N., Lockhard, A., Hsu, CP., Baker, N., Galimi, F., Beltran, P., Baselga, J..Anticancer activity of the type I insulin-like growth factor receptor antagonist, ganitumab, in combination with the death receptor 5 agonist, conatumumab.Targeted Oncology;Tabernero J, Chawla SP, Kindler H, Reckamp K, Chiorean EG, Azad NS, Lockhart AC, Hsu CP, Baker NF, Galimi F, Beltran P, Baselga J. Anticancer activity of the type I insulin-like growth factor receptor antagonist, ganitumab, in combination with the death receptor 5 agonist, conatumumab. Target Oncol. 2014 May 11. [Epub ahead of print]
citation: Tabernero J, Chawla SP, Kindler H, Reckamp K, Chiorean EG, Azad NS, Lockhart AC, Hsu CP, Baker NF, Galimi F, Beltran P, Baselga J. Anticancer activity of the type I insulin-like growth factor receptor antagonist, ganitumab, in combination with the death receptor 5 agonist, conatumumab. Target Oncol. 2015 Mar;10(1):65-76. doi: 10.1007/s11523-014-0315-z. Epub 2014 May 11.