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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00819169
• Other study ID #: 20070411
• Secondary ID: QUILT-3.026
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: January 6, 2009
• Last updated: November 2, 2016
• Start date: January 2009
• Est. completion date: October 2011

Study information

• Verified date: November 2016
• Source: NantCell, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesUnited States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: Western Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 89
• Est. completion date: October 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Colorectal Cancer
• Colorectal Neoplasms
• Locally Advanced
• Metastatic Cancer
• Neoplasm Metastasis
• Non-Small Cell Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Sarcoma
• Solid Tumors

Intervention

Biological:
• AMG 479
AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
• AMG 655
AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NantCell, Inc.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incedence of dose limiting toxicity		Length of Study	Yes
Primary	Objective response rate		Length of Study	No
Secondary	Time to response		Length of Study	No
Secondary	Duration of response		Length of Study	No
Secondary	Progression free survival		Length of Study	No
Secondary	To evaluate anti-AMG 655 antibody formation and anti-AMG 479 antibody formation		Length of Study	No
Secondary	To evaluate the PK of AMG 655 and of AMG 479		Length of Study	No

External Links

•   AmgenTrials clinical trials website