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A Study Evaluating GDC-0980 Administered Once Weekly in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma | Clinical Trials | Clareo Health

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A Study Evaluating GDC-0980 Administered Once Weekly in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma

An Open-label, Phase I, Dose-escalation Study Evaluating GDC-0980 Administered Once Weekly in Patients With Refractory Solid Tumors and Non-hodgkin's Lymphoma

NCT00854126•Genentech, Inc.

View on ClinicalTrials.gov

Summary

This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0980 administered to patients with incurable, locally advanced or metastatic solid malignancy or NHL that has progressed or failed to respond to at least one prior regimen or for which there is no standard therapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically documented, incurable, locally advanced or metastatic solid malignancies, or NHL without leukemic phase, that has progressed despite standard of care therapy or for which there is no standard therapy of proven clinical benefit
•A biopsy-accessible lesion from which tissue can be obtained safely
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
•Life expectancy \>= 12 weeks
•Adequate hematologic and organ function within 28 days before initiation of GDC-0980
•Documented willingness to use an effective means of contraception for both men and women while participating in the study
•For patients participating in DCE-MRI assessments: at least one metastatic lesion measuring \>/= 3 cm in the liver or \>/= 2 cm elsewhere (lung and mediastinum lesions are ineligible) in at least one dimension (on CT scan)

Exclusion Criteria

•Leptomeningeal disease as the only manifestation of the current malignancy
•History of Type 1 or 2 diabetes mellitus requiring regular medication
•Grade \>=2 hypercholesterolemia or hypertriglyceridemia
•Malabsorption syndrome or other condition that would interfere with enteral absorption
•Known untreated malignancies of the brain or spinal cord, or treated brain metastases that are not radiographically stable for \>= 3 months
•Congenital long QT syndrome or screening QTc \> 470 msec
•Active congestive heart failure or ventricular arrhythmia requiring medication
•Ejection fraction that is \<50% or is below the LLN (whichever is higher), as determined by echocardiogram or MUGA scan
•Active infection requiring IV antibiotics
•Requirement for any daily supplemental oxygen
+16 more criteria

Locations (3)

Boston, Massachusetts, United States

Villejuif, France

Manchester, United Kingdom

Key Dates

Start Date

May 1, 2009

Primary Completion Date

July 1, 2012

Completion Date

July 1, 2012

Last Updated

November 2, 2016

Enrollment

ACTUAL participants

Conditions

Non-Hodgkin's Lymphoma, Solid Cancers

Interventions

GDC-0980

DRUG