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QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma

ABSTRACT: This is a phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-arm trial to be conducted in the United States, Europe, and Asia. Approximately 150 eligible KRAS-mutant metastatic colorectal cancer subjects who have failed first line fluoropyrimidine and oxaliplatin-based regimen with or without anti-VEGF therapy will be randomized in a 1:1:1 ratio to receive AMG 479 placebo plus AMG 655 with FOLFIRI, or AMG 479 plus AMG 655 placebo with FOLFIRI, or AMG 479 placebo plus AMG 655 placebo with FOLFIRI

DISEASE(S): Adenocarcinoma,Metastatic Colorectal Cancer,Malignant Neoplasm Of Rectum,Colon Cancer,Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2065658 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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

Project description: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.

| 2066083 | ecrin-mdr-crc

A Phase 1b/2 Open Label, Dose Escalation Study of AMG 655 in Combination with AMG 479 in Subjects with Advanced, Refractory Solid Tumors.--------------------------------------------------------Estudio abierto de fase 1b/2 con escalada de dosis de AMG 655 en combinación con AMG 479 en sujetos con tumores sólidos refractarios y avanzados.

Project description:Primary objectives: Part 1: To identify a dose of AMG 655 in combination with AMG 479 that is safe andtolerated as determined by the incidence of dose limiting toxicity (DLT).Part 2: To estimate the efficacy, as measured by the objective response rate (ORR;confirmed complete response [CR] and partial response [PR] using modified Response Evaluation Criteria in Solid Tumors [RECIST]) of AMG 655 in combination with AMG 479. Primary endpoints: Part 1: The incidence of adverse events and clinical laboratory abnormalities defined as DLTPart 2: ORR (confirmed CR and PR, by modified RECIST)

| 2525060 | ecrin-mdr-crc

Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer

Project description:This phase 1/2, multi-center, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with mFOLFOX6 and bevacizumab compared with mFOLFOX6 and bevacizumab alone in subjects with previously untreated metastatic colorectal cancer (CRC). The clinical benefit of AMG 655 in combination with mFOLFOX6 and bevacizumab will be measured by progression-free survival, objective response rate, time to response, duration of response, and overall survival. This study is also designed to evaluate the safety and tolerability of AMG 655 in combination with mFOLFOX6 and bevacizumab and to evaluate anti-AMG 655 antibody formation and the pharmacokinetics of AMG 655.

| 2051414 | ecrin-mdr-crc

A Phase 2, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safetyand Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 Versus FOLFIRI for the Second-line Treatment of KRAS-mutant Metastatic Colorectal Carcinoma

Project description:Primary objectives: The primary objective is to estimate the treatment effect on progression-free survival(PFS) of AMG 655 plus FOLFIRI or AMG 479 plus FOLFIRI relative to FOLFIRI alone when administered as a second-line treatment for subjects with metastatic colorectalcancer (mCRC) whose tumors express mutant-type Kirsten rat sarcoma virus oncogene homolog (KRAS). Primary endpoints: Progression Free Survival (PFS)PFS time is defined as the time from the date of randomization to the first observation of disease progression (as classified by modified RECIST based on the investigator assessment of radiographic scans, or clinical progression whichever occurs first,) or death due to any cause. If a subject’s disease has not progressed and the subject is alive by the analysis data cut-off date, PFS will be censored at the last date they are known to be progression-free (ie, the last evaluable disease assessment date).

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Pharmacodynamics, Safety, and Clinical Efficacy of AMG 811, a Human Anti-Interferon-γ Antibody, in Patients With Discoid Lupus Erythematosus [blood]

Project description:This is a phase I randomized, double-blind, placebo-controlled crossover study which sought to evaluate a single dose of AMG 811, an anti-IFNγ antibody, in patients with DLE. The patients in sequence 1 received AMG 811 followed by placebo, while those in sequence 2 received placebo followed by AMG 811. Pharmacodynamic end points included global transcriptional analyses of lesional and nonlesional skin, IFNγ blockade signature (IGBS) transcriptional scores in the skin and blood, keratinocyte IFNγ RNA scores, and serum levels of CXCL10 protein

2017-06-23 | GSE100430 | GEO

Pharmacodynamics, Safety, and Clinical Efficacy of AMG 811, a Human Anti-Interferon-γ Antibody, in Patients With Discoid Lupus Erythematosus [skin]

2017-06-23 | GSE100093 | GEO

Insulin-like growth factor-1 receptor inhibitor, AMG-479, in cetuximab-refractory head and neck squamous cell carcinoma

Project description:Recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) remains one of the most difficult cancers to treat with limited chemotherapeutic options. Here, we describe a patient with HNSCC who had complete response to methotrexate (MTX) after progressing on multiple cytotoxic agents; cetuximab, a monoclonal antibody (mAb) against Epidermal Growth Factor Receptor (EGFR), and AMG 479, a mAb against Insulin-like Growth Factor-1 Receptor (IGF-1R). In tumor tissue of this patient we observed gene expression modulation by cetuximab and AMG 479 suggesting crosstalk between the EGFR and IGF-1R pathways that may have sensitized the tumor to MTX. This represents a promising novel approach to development of targeted agents in refractory cancer. Keywords: tumor response 10 samples from different time points during course of treatment in a single individual.

2010-08-03 | E-GEOD-9600 | biostudies-arrayexpress

Insulin-like growth factor-1 receptor inhibitor, AMG-479, in cetuximab-refractory head and neck squamous cell carcinoma

2010-08-03 | GSE9600 | GEO

Transcription profiling of rat tissues dosed with AMG A or AMG B

Project description:To evaluate and characterize gene expression changes and toxicity following oral gavage administration of AMG A & AMG B in male Sprague Dawley rats. Experiment Overall Design: This toxicogenomics study is designed to determine the toxicity and gene expression of AMG A and AMG B dosed orally daily (AMG A at 0mg/kg, 3mg/kg and 30 mg/kg and AMG B at 0mg/kg, 3mg/kg and 60mg/kg) for 1, 4 and 14 days. These doses are expected to produce mild and moderate changes in clinical pathology and histology associated with the pharmacologic antiangiogenic effect.

2008-06-11 | E-GEOD-10015 | biostudies-arrayexpress

Expression data from rat tissues dosed with AMG A or AMG B

Project description:To evaluate and characterize gene expression changes and toxicity following oral gavage administration of AMG A & AMG B in male Sprague Dawley rats. Keywords: dose response

2007-12-23 | GSE10015 | GEO

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