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

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Genentech

Status and phase

Completed
Phase 1

Conditions

Solid Cancers

Treatments

Drug: GDC-0068

Study type

Interventional

Funder types

Industry

Identifiers

NCT01090960
PAM4743g
2009-015060-34 (EudraCT Number)
GO01335 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

52 participants in 1 patient group

A
Experimental group
Treatment:
Drug: GDC-0068

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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