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AMG 386

DRUG14 trials

Sponsors

Amgen, National Cancer Institute (NCI), University of Colorado, Denver

Conditions

Advanced Hepatocellular CarcinomaAdvanced Renal Cell CarcinomaAdvanced Solid TumorsCancerCarcinomaColon CancerColorectal CancerFallopian Tube Cancer

Phase 1

Study Evaluating AMG 386 in Adult Patients With Advanced Solid Tumors
CompletedNCT00102830
AmgenTumors
Updated: 2010-08-20
To Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 386 When Used in Combination With AMG 706, Bevacizumab, Sorafenib, or Sunitinib.
CompletedNCT00861419
AmgenAdvanced Solid Tumors
Start: 2005-12-31Target: 88Updated: 2017-02-08
A Pharmacokinetic Study of AMG 386 in Cancer Subjects With Normal and Impaired Renal Function
CompletedNCT01331941
AmgenAdvanced Solid Tumors, Kidney Disease, Renal Impairment
Start: 2011-09-19Updated: 2017-11-06
Phase 1b/2 Trial of AMG386 With Pemetrexed and Carboplatin in Non-Small Cell Lung Cancer
CompletedNCT01666977
AmgenNon Small Cell Lung Cancer
Start: 2012-08-31End: 2015-11-30Updated: 2016-06-03
AMG 386 Drug-Drug Interaction Study With Paclitaxel
CompletedNCT01992341
AmgenAdvanced Solid Tumors
Start: 2012-07-31End: 2014-09-30Updated: 2014-09-23

Phase 2

AMG 386, 20060159 Phase 2, RCC 1st Line in Combination With Sorafenib
CompletedNCT00467025
AmgenAdvanced Renal Cell Carcinoma
Start: 2007-05-31End: 2014-06-30Updated: 2016-03-23
Phase 2 AMG 386 in Comb. Paclitaxel for Subjects With Advanced Recurrent Epithelial Ovarian or Primary Peritoneal Cancer
CompletedNCT00479817
AmgenFallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cancer
Start: 2007-07-05End: 2019-12-09Updated: 2019-12-18
Phase 2 Study of AMG 386 Plus Paclitaxel With or Without Bevacizumab as First Line Therapy in Her2-Negative Breast Cancer Patients
CompletedNCT00511459
AmgenLocally Recurrent and Metastatic Breast Cancer
Start: 2007-07-31End: 2014-05-31Updated: 2015-10-29
A Phase 2, Randomized, Double Blind, Placebo Controlled Study of AMG 386 in Combination With FOLFIRI in Subjects With Previously Treated Metastatic Colorectal Carcinoma
CompletedNCT00752570
AmgenCancer, Carcinoma, Colon Cancer +7
Start: 2008-11-30End: 2012-06-30Updated: 2015-09-02
A Study of the Effectiveness and Safety of AMG 386 and Sorafenib to Treat Advanced or Inoperable Hepatocellular Cancer
CompletedNCT00872014
AmgenAdvanced Hepatocellular Carcinoma, Inoperable Hepatocellular Carcinoma
Start: 2009-08-31End: 2015-06-30Updated: 2016-04-04
AMG 386 and Abiraterone for Advanced Prostate Cancer
CompletedNCT01553188
National Cancer Institute (NCI)Neoplasm, Prostate, Neoplasm,Prostatic, Prostate Cancer +1
Start: 2012-02-08End: 2018-07-01Updated: 2019-03-05
Trebananib (AMG 386) in Combination With Docetaxel for Advanced Urothelial Carcinoma
WithdrawnNCT01907308
University of Colorado, DenverUrothelial Carcinoma
Start: 2014-02-28End: 2014-04-30Updated: 2014-04-29

Phase 3

TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer
CompletedNCT01204749
AmgenFallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cancer
Start: 2010-11-30End: 2016-12-31Updated: 2016-12-15
TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer
TerminatedNCT01493505
AmgenFallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer
Start: 2012-01-31End: 2016-12-31Updated: 2017-02-23

Related Papers

Trebananib or placebo plus carboplatin and paclitaxel as first-line treatment for advanced ovarian cancer (TRINOVA-3/ENGOT-ov2/GOG-3001): a randomised, double-blind, phase 3 trial.
2019-05-0767 citations
Health-related quality of life in women with recurrent ovarian cancer receiving paclitaxel plus trebananib or placebo (TRINOVA-1).
2016-03-306 citations
Impact of trebananib plus weekly paclitaxel on overall survival (OS) in patients (pts) with recurrent ovarian cancer and ascites: Results from the phase III TRINOVA-1 study.
Journal of Clinical Oncology2015-05-2015 citations
Trebananib (AMG 386) plus weekly paclitaxel with or without bevacizumab as first-line therapy for HER2-negative locally recurrent or metastatic breast cancer: A phase 2 randomized study
The Breast2015-03-0549 citations
Anti-angiopoietin therapy with trebananib for recurrent ovarian cancer (TRINOVA-1): a randomised, multicentre, double-blind, placebo-controlled phase 3 trial.
2014-06-17211 citations
Evaluation of pharmacokinetic (PK) drug-drug interactions (DDI) between trebananib (AMG 386) and paclitaxel (PTX) in patients (pts) with advanced solid tumors.
Journal of Clinical Oncology2014-05-201 citations
Expression of angiopoietin (Ang) pathway markers and their relationship to progression-free survival (PFS) in TRINOVA-1.
Journal of Clinical Oncology2014-05-20
A safety study of trebananib (AMG 386) and abiraterone in metastatic castration-resistant prostate cancer (mCRPC).
Journal of Clinical Oncology2014-05-20
Phase II study of first-line trebananib plus sorafenib in patients with advanced hepatocellular carcinoma (HCC).
Journal of Clinical Oncology2014-01-207 citations