Overview

This trial is active, not recruiting.

Conditions advanced solid tumors, carcinoid, colorectal cancer, locally advanced, lymphoma, metastatic cancer, non-small cell lung cancer, sarcoma, solid tumors
Treatments folfox6, conatumumab, ganitumab, bevacizumab
Phase phase 2
Targets IGF1-R, TRAIL, VEGF
Sponsor NantCell, Inc.
Start date March 2011
End date January 2017
Trial size 12 participants
Trial identifier NCT01327612, 20101116, QUILT-3.030

Summary

The purpose of this protocol is to allow continued treatment with conatumumab and/or AMG 479, with or without chemotherapy to subjects without disease progression whose previous studies were closed.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Combination treatment: Conatumumab Q2W or Q3W + ongoing chemotherapy or ganitumab.
folfox6 Oxaliplatin-Leucovorin-Fluorouracil chemotherapy
Oxaliplatin: 100mg/m2, IV in 500mL of D5W over 120 minutes on Day 1 Leucovorin: 400mg/m2, IV diluted in D5W over 120 minutes (concurrently with oxaliplatin) on Day 1 Fluorouracil: 400 mg/m2, IV bolus, after leucovorin, on Day 1 Fluorouracil: 2400mg/m2, CIV over 46 hours (single dose) start on Day 1 Cycle frequency: repeat every 14 days until disease progression or unacceptable toxicity
conatumumab AMG 655
Conatumumab is an investigational, fully human monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR-5.
ganitumab AMG 479
Ganitumab is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
bevacizumab Avastin
Recombinant humanized monoclonal antibody targeted against vascular endothelial growth factor (VEGF); angiogenesis inhibitor.
(Experimental)
Monotherapy treatment: Conatumumab Q2W or Q3W; or AMG 479 Q3W or Q4W
conatumumab AMG 655
Conatumumab is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR5.
ganitumab AMG 479
Ganitumab is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.

Primary Outcomes

Measure
To evaluate the safety profile, including adverse events and serious adverse events, of conatumumab, with or without co-therapy, or AMG 479.
time frame: Two to three years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - To be enrolled in this study, subjects must be currently enrolled in a prior Amgen-sponsored conatumumab or AMG 479 study and are eligible according to the parent study to receive their next dose of conatumumab (with or without co-therapy), or AMG 479 alone. Subjects must have their eligibility assessed for this study and be enrolled within 30 days of their last treatment on the parent protocol Exclusion Criteria: - Discontinued from a conatumumab study due to an adverse event considered by the investigator to be related to conatumumab treatment, including intolerance to conatumumab - Subjects determined to have disease progression during their participation in the parent Amgen study - Woman or man with partner of childbearing potential not consenting to use adequate contraceptive precautions ie, double barrier contraceptive methods (eg, diaphragm plus condom), or abstinence during the course of the study and for 6 months after the last dose of protocol-specified therapy administration - Subject is pregnant or breast feeding, or planning to become pregnant within 6 months after the last dose of protocol-specified therapy administration - Male subject with a pregnant partner who is not willing to use a condom during treatment and for an additional 6 months after the last dose of protocol-specified therapy administration - Subject has previously entered this study - Subject will not be available for protocol required study visits, to the best of the subject and investigator's knowledge - Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures

Additional Information

Official title A Phase 2 Open Label Extension Study of Conatumumab and AMG 479
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by NantCell, Inc..