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NCT Number: NCT01090960

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

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.

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Key information

Conditions

Solid Cancers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GDC-0068

Drug

Oral repeating dose

Primary outcomes

  1. Occurrence of adverse events by NCI CTCAE grade and associated dose of GDC-0068

    Time frame: Through study completion or early study discontinuation

  2. Occurrence of dose-limiting toxicities (DLTs) by NCI CTCAE grade and associated dose of GDC-0068

    Time frame: Through study completion or early study discontinuation

  3. Occurrence of Grade 3 or 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0068

    Time frame: Through study completion or early study discontinuation

  4. PK parameters after single and multiple doses of GDC-0068

    Time frame: Through study completion or early study discontinuation

Secondary outcomes

  1. Best overall response, duration of objective response, and progression-free survival (PFS) for patients with measurable disease according to RECIST

    Time frame: Through study completion or early study discontinuation

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Mar 23, 2010
Registry last updated
Jul 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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