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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01090960
First received: March 19, 2010
Last updated: October 26, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Solid Cancers
 Drug: GDC-0068
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety and Tolerability of GDC-0068 in Patients With Refractory Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Occurrence of adverse events by NCI CTCAE grade and associated dose of GDC-0068 [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • PK parameters after single and multiple doses of GDC-0068 [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: March 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: GDC-0068
Oral repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01090960

Locations
Spain
Valencia, Spain, 46010
Sponsors and Collaborators
Genentech
Investigators
Study Director: Premal Patel, M.D., Ph.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01090960     History of Changes
Other Study ID Numbers: PAM4743g, 2009-015060-34, GO01335
Study First Received: March 19, 2010
Last Updated: October 26, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

ClinicalTrials.gov processed this record on May 21, 2013