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GDC-0980

DRUG10 trials

Sponsors

Genentech, Inc.

Conditions

Breast CancerEndometrial CarcinomaHealthy VolunteerNon-Hodgkin's Lymphoma, Solid CancersRenal Cell CarcinomaSolid Cancers

Phase 1

A Study Evaluating GDC-0980 Administered Once Daily in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma
CompletedNCT00854152
Genentech, Inc.Non-Hodgkin's Lymphoma, Solid Cancers
Start: 2009-03-31End: 2014-11-30Updated: 2016-11-02
A Study Evaluating GDC-0980 Administered Once Weekly in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma
CompletedNCT00854126
Genentech, Inc.Non-Hodgkin's Lymphoma, Solid Cancers
Start: 2009-05-31End: 2012-07-31Updated: 2016-11-02
Study of the Safety and Pharmacology of GDC-0980 in Combination With Paclitaxel With or Without Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer
CompletedNCT01254526
Genentech, Inc.Breast Cancer
Start: 2010-12-31End: 2013-04-30Updated: 2016-11-02
A 3-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0980, the Effect of Food, and the Effect of Rabeprazole on the Pharmacokinetics of the Tablet
CompletedNCT01287091
Genentech, Inc.Healthy Volunteer
Start: 2010-10-14End: 2011-02-03Updated: 2022-12-13
A Study of the Safety and Pharmacology of GDC-0980 in Combination With Either Paclitaxel and Carboplatin (With or Without Bevacizumab) or Pemetrexed and Cisplatin in Patients With Solid Tumors
CompletedNCT01301716
Genentech, Inc.Solid Cancers
Start: 2011-09-30End: 2014-08-31Updated: 2016-11-02
GDC-0980 in Combination With a Fluoropyrimidine, Oxaliplatin, and Bevacizumab in Patients With Advanced Solid Tumors
CompletedNCT01332604
Genentech, Inc.Solid Cancers
Start: 2011-07-31End: 2015-06-30Updated: 2016-11-02
Study to Determine the Effect of Ketoconazole on the Pharmacokinetics of GDC-0980
CompletedNCT01473316
Genentech, Inc.Healthy Volunteer
Start: 2011-11-30End: 2011-12-31Updated: 2016-11-02

Phase 2

Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Participants Resistant to Aromatase Inhibitor Therapy
CompletedNCT01437566
Genentech, Inc.Breast Cancer
Start: 2011-10-31End: 2016-04-30Updated: 2016-11-02
Study of GDC-0980 Versus Everolimus in Participants With Metastatic Renal Cell Carcinoma Who Have Progressed on or Following Vascular Endothelial Growth Factor- (VEGF) Targeted Therapy
CompletedNCT01442090
Genentech, Inc.Renal Cell Carcinoma
Start: 2011-10-31End: 2015-07-31Updated: 2016-08-10
A Study of GDC-0980 in the Treatment of Recurrent or Persistent Endometrial Carcinoma
CompletedNCT01455493
Genentech, Inc.Endometrial Carcinoma
Start: 2011-12-31End: 2014-01-31Updated: 2016-08-11

Related Papers

Retrospective Assessment of Translational Pharmacokinetic-Pharmacodynamic Modeling Performance: A Case Study with Apitolisib, a Dual PI3K/mTOR Inhibitor.
2024-05-031 citations
A phase Ib study of pictilisib (GDC-0941) in combination with paclitaxel, with and without bevacizumab or trastuzumab, and with letrozole in advanced breast cancer.
2018-09-0556 citations
Pictilisib for oestrogen receptor-positive, aromatase inhibitor-resistant, advanced or metastatic breast cancer (FERGI): a randomised, double-blind, placebo-controlled, phase 2 trial.
2016-05-04227 citations
Abstract PD6-03: High prevalence and clonal heterogeneity of ESR1 mutations (mt) in circulating tumor DNA (ctDNA) from patients (pts) enrolled in FERGI, a randomized phase II study testing pictilisib (GDC-0941) in combination with fulvestrant (F) in pts that failed a prior aromatase inhibitor (AI)
Cancer Research2016-02-152 citations
Abstract A03: Comprehensive predictive biomarker evaluation in two phase II clinical trials of the PI3K/mTOR inhibitor GDC-0980 in metastatic renal cell carcinoma and advanced endometrial cancer
Molecular Cancer Therapeutics2015-07-012 citations
Abstract A34: GDC-0980, a dual PI3K/mTOR inhibitor, selectively inhibits NF2 mutant malignant mesothelioma (MM) cells and inhibits TOR signaling without activating Akt or ERK
Molecular Cancer Therapeutics2015-07-01
Abstract B03: Pharmacodynamic biomarker evaluation in phase I clinical trials of selective PI3K and PI3K/mTOR inhibitors
Molecular Cancer Therapeutics2015-07-01
A randomized phase II study of GDC-0980 versus everolimus in metastatic renal cell carcinoma (mRCC) patients (pts) after VEGF-targeted therapy (VEGF-TT).
Journal of Clinical Oncology2014-05-2019 citations
Phase II trial of GDC-0980 (dual PI3K/mTOR inhibitor) in patients with advanced endometrial carcinoma: Final study results.
Journal of Clinical Oncology2014-05-2018 citations