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
Status: | Completed |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | April 2012 |
End Date: | January 2015 |
A Phase Ib, Open-Label, Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of GDC-0973 and GDC-0068 in Patients With Locally Advanced or Metastatic Solid Tumors
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.
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.
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
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