A Study of GDC-0941 in Participants With Locally Advanced or Metastatic Solid Tumors for Which Standard Therapy Either Does Not Exist or Has Proven Ineffective or Intolerable

NCT ID: NCT00876109

Last Updated: 2016-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2013-11-30

Brief Summary

This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of orally administered GDC-0941 administered once daily (QD) and twice daily (BID) in the treatment of advanced or metastatic solid tumors.

Conditions

Solid Cancers

Keywords

Metastatic Solid Tumors; PI3K; PI3K Inhibitors

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A: GDC-0941 QD Dose Escalation

Participants will receive GDC-0941 for up to 1 year, administered orally QD at a starting dose of 15 milligrams (mg).

Group Type: EXPERIMENTAL

GDC-0941

Intervention Type: DRUG

GDC-0941 will be administered in escalating oral doses QD or BID in Groups A and B, respectively. In Group C, the dose/regimen will be determined on the basis of data from Groups A and B. The overall starting dose will be 15 mg administered in the first cohort enrolled in Group A.

Group B: GDC-0941 BID Dose Escalation

Participants will receive GDC-0941 for up to 1 year, administered orally BID at a starting dose determined from Group A assessments.

Group Type: EXPERIMENTAL

GDC-0941

Intervention Type: DRUG

GDC-0941 will be administered in escalating oral doses QD or BID in Groups A and B, respectively. In Group C, the dose/regimen will be determined on the basis of data from Groups A and B. The overall starting dose will be 15 mg administered in the first cohort enrolled in Group A.

Group C: GDC-0941 QD or BID Expansion

Participants will receive GDC-0941 for up to 1 year, administered orally QD or BID. The dose/regimen will be determined on the basis of data from Groups A and B.

Group Type: EXPERIMENTAL

GDC-0941

Intervention Type: DRUG

GDC-0941 will be administered in escalating oral doses QD or BID in Groups A and B, respectively. In Group C, the dose/regimen will be determined on the basis of data from Groups A and B. The overall starting dose will be 15 mg administered in the first cohort enrolled in Group A.

Interventions

GDC-0941

GDC-0941 will be administered in escalating oral doses QD or BID in Groups A and B, respectively. In Group C, the dose/regimen will be determined on the basis of data from Groups A and B. The overall starting dose will be 15 mg administered in the first cohort enrolled in Group A.

Intervention Type: DRUG

Other Intervention Names

PI3-Kinase Inhibitor

Eligibility Criteria

Inclusion Criteria

• Participants with histologically documented, incurable, locally advanced or metastatic solid malignancy that has progressed or failed to respond to at least one prior regimen, and who are not candidates for regimens known to provide clinical benefit
• Evaluable or measurable disease per RECIST
• Life expectancy of greater than or equal to (>/=) 12 weeks
• Documented willingness to use an effective means of contraception (for both men and women) while participating in the study

Exclusion Criteria

• Leptomeningeal disease as the only manifestation of the current malignancy
• History of Type 1 or 2 diabetes mellitus requiring regular medication
• Any condition requiring anticoagulants, such as warfarin, heparin, or thrombolytics
• Malabsorption syndrome or other condition that would interfere with enteral absorption
• Known untreated central nervous system (CNS) malignancies or treated brain metastases that are not radiographically stable for >/=3 months
• Active congestive heart failure or ventricular arrhythmia requiring medication
• Uncontrolled ascites requiring weekly large-volume paracentesis for 3 consecutive weeks prior to enrollment
• Active infection requiring intravenous (IV) antibiotics
• Requirement for any daily supplemental oxygen
• Uncontrolled hypomagnesemia or hypokalemia, defined as values below the lower limit of normal (LLN), or hypercalcemia above the upper limit of normal (ULN) for the institution despite adequate electrolyte supplementation or management
• Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
• Known human immunodeficiency virus (HIV) infection
• Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participant at high risk from treatment complications
• Significant traumatic injury within 3 weeks before Day 1
• Major surgical procedure within 4 weeks prior to initiation of study treatment
• Treatment with chemotherapy, hormonal therapy (except gonadotropin releasing hormone [GnRH] agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, or radiation therapy (except palliative radiation to bony metastases) as cancer therapy within 4 weeks prior to initiation of study treatment
• Palliative radiation to bony metastases within 2 weeks prior to initiation of study treatment
• Need for chronic corticosteroid therapy for greater than (>) 7 days

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jerry Hsu, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

Scottsdale, Arizona, United States

Boston, Massachusetts, United States

Detroit, Michigan, United States

Countries

United States

Other Identifiers

GO01300

Identifier Type: OTHER

Identifier Source: secondary_id

GDC4255g

Identifier Type: -

Identifier Source: org_study_id