A Study Evaluating the Safety and Tolerability of GDC-0068 in Patients With Refractory Solid Tumors

Study Overview
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Brief Summary
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This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0068 administered to patients with incurable, locally advanced or metastatic solid malignancy that has progressed or failed to respond to at least one prior regimen or for which there is no standard therapy. This study is expected to enroll approximately 39 to 57 patients at approximately two sites in Spain.

Official Title
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An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety and Tolerability of GDC-0068 in Patients With Refractory Solid Tumors

Conditions
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Solid Cancers

Intervention / Treatment
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* Drug: GDC-0068


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically documented, incurable, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable. Evaluable or measurable disease Life expectancy >= 12 weeks Adequate hematologic and organ function within 14 days before initiation of GDC-0068 Documented willingness to use an effective means of contraception (e.g., abstinence, hormonal or double barrier method, surgically sterilized partner) for both men and women while participating in the study Exclusion Criteria: 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 Leptomeningeal disease as the only manifestation of the current malignancy Known untreated malignancies of the brain or spinal cord, or treated brain metastases that are not radiographically stable for >= 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: GDC-0068<br>* Oral repeating dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events by NCI CTCAE grade and associated dose of GDC-0068 |  | Through study completion or early study discontinuation | 
| Occurrence of dose-limiting toxicities (DLTs) by NCI CTCAE grade and associated dose of GDC-0068 |  | Through study completion or early study discontinuation | 
| Occurrence of Grade 3 or 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0068 |  | Through study completion or early study discontinuation | 
| PK parameters after single and multiple doses of GDC-0068 |  | Through study completion or early study discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best overall response, duration of objective response, and progression-free survival (PFS) for patients with measurable disease according to RECIST |  | Through study completion or early study discontinuation |