Clinical trial · Interventional

QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors

A Phase 1b/2 Open Label, Dose Escalation Study of AMG 655 in Combination With AMG 479 in Subjects With Advanced, Refractory Solid Tumors

NCT00819169CI-TRIAL-00079936terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Sponsor decision - subjects rolled over to protocol 20101116

Summary

Brief summary (as posted)

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.

Conditions

Conditions (8)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Colorectal Cancer	Malignant Colorectal Neoplasm	CURATED_BROADER	0.80
Locally Advanced	—	UNRESOLVED	—
Metastatic Cancer	Malignant Neoplasm	CURATED_BROADER	0.78
Non-Small Cell Lung Cancer	Lung Non-Small Cell Carcinoma	ALIAS	0.90
Ovarian Cancer	Malignant Ovarian Neoplasm	CURATED_EXACT	0.92
Pancreatic Cancer	Malignant Pancreatic Neoplasm	CURATED_EXACT	0.92
Sarcoma	Sarcoma	ONTOLOGY_EXACT	0.98
Solid Tumors	Solid Neoplasm	CURATED_BROADER

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
AMG 479	Biological	Ganitumab	ALIAS
AMG 655	Biological	Conatumumab	ALIAS

Design

Arms and outcomes

Arms (4)

type
EXPERIMENTAL
label
Part 1 Cohort 3
description
AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)
interventionNames
1. Biological: AMG 479
2. Biological: AMG 655
type
EXPERIMENTAL
label
Part 1 Cohort 1
description
AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)
interventionNames
1. Biological: AMG 479
2. Biological: AMG 655
type
EXPERIMENTAL
label
Part 1 Cohort 2
description

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 16 Years

Show eligibility criteria text

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)

References

Publications (1)

BACKGROUNDTabernero 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. PMID 24816908