Breast Cancer Clinical Trial

A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0973 in Combination With GDC-0068 When Administered in Participants With Locally Advanced or Metastatic Solid Tumors

Summary

This open-label, multicenter, Phase Ib dose-escalation study will evaluate the safety, tolerability and pharmacokinetics of oral dosing of GDC-0973 and GDC-0068 administered in combination in patients with locally advanced or metastatic solid tumors. Cohorts of patients will receive multiple ascending doses of GDC-0973 and GDC-0068. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically documented locally advanced or metastatic solid tumors for which standard therapies either do not exist or have proven ineffective or intolerable
Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)
Life expectancy >/= 12 weeks
Adequate hematologic and end organ function

Exclusion Criteria:

History of prior significant toxicity from another MEK pathway inhibitor requiring discontinuation of treatment
History of prior significant toxicity from another phosphoinositide 3-kinase (PI3K) or Akt pathway or mammalian target of rapamycin (mTOR) inhibitor requiring discontinuation of treatment
Anti-cancer therapy within 28 days prior to first dose of study drug, except as stated in protocol
History of type I or type II diabetes mellitus requiring insulin
Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease)
Clinically significant history of liver disease, current alcohol abuse, or current known active infection with HIV, hepatitis B or hepatitis C virus
Active autoimmune disease
Pregnant or lactating women
Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
History of glaucoma
History of retinal vein occlusion

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

67

Study ID:

NCT01562275

Recruitment Status:

Completed

Sponsor:

Genentech, Inc.

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There are 5 Locations for this study

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Boston Massachusetts, 02215, United States

Detroit Michigan, 48201, United States

Nashville Tennessee, 37203, United States

Barcelona , 08035, Spain

Valencia , 46010, Spain

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

67

Study ID:

NCT01562275

Recruitment Status:

Completed

Sponsor:


Genentech, Inc.

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