Evaluating the Safety and Tolerability of GDC-0349 in Patients With Locally Advanced or Metastatic Solid Tumors or Non Hodgkin's Lymphoma

NCT ID: NCT01356173

Last Updated: 2016-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-12-31

Brief Summary

This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetic (PK) of GDC-0349 administered once daily (QD), orally (PO).

Conditions

Non-Hodgkin's Lymphoma, Solid Tumor

Keywords

solid cancers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: EXPERIMENTAL

GDC-0349

Intervention Type: DRUG

Oral escalating dose

Interventions

GDC-0349

Oral escalating dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically documented, locally advanced or metastatic solid malignancy or NHL without leukemic phase that has progressed or failed to respond to at least one prior regimen and/or are not candidates for regimens known to provide clinical benefit
• Evaluable or measurable disease per RECIST v1.1 or IWG response criteria for patients with NHL and/or the following: prostate cancer patients with non-measurable disease are eligible if they have two rising prostate-specific antigen (PSA) levels >= 5 ng/mL measured >= 2 weeks apart that meet the PSA, and Working Group criteria for progression prior to initiation of study treatment, and ovarian cancer patients with non-measurable disease are eligible if they have two rising CA-125 levels greater than the ULN >= 2 weeks apart prior to initiation of study treatment.
• ECOG performance status of 0 or 1 at screening
• Life expectancy of >= 12 weeks
• Adequate hematologic and organ function within 14 days prior to initiation of study treatment
• Documented willingness to use an effective means of contraception for both men and women while participating in the study and for 90 days after the last dose of GDC-0349
• Willingness to provide archival tumor tissue

Exclusion Criteria

• Leptomeningeal disease as the only manifestation of the current malignancy
• History of Type 1 or 2 diabetes requiring daily medication
• Known untreated central nervous system (CNS) malignancies or treated brain metastases that are not radiographically stable for >= 3 months prior to initiation of study treatment
• Active congestive heart failure or ventricular arrhythmia requiring medication
• Uncontrolled ascites requiring weekly large-volume paracentesis for 3 consecutive weeks prior to initiation of study treatment
• Active infection requiring intravenous (IV) antibiotics
• Patients requiring any daily supplemental oxygen
• Uncontrolled hypomagnesemia or hypokalemia
• Any condition requiring anti-coagulants such as warfarin, heparin, or anti-thrombotics. Prophylactic anti-coagulation and/or local application of thrombolytic agents for catheter patency may be allowed for patients with normal INR and with prior approval from the Medical Monitor
• 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, that may affect the interpretation of the results, or renders the patients at high risk from treatment complications
• Significant traumatic injury within 3 weeks prior to initiation of GDC-0349
• Major surgical procedure within 4 weeks prior to initiation of GDC-0349
• Treatment with chemotherapy, hormonal therapy (except 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. Kinase inhibitors, approved by national regulatory authorities, may be used up to 2 weeks prior to initiation of GDC-0349, provided that any drug-related toxicity has completely resolved and prior approval is obtained from the Medical Monitor.
• Palliative radiation to bony metastases within 2 weeks prior to initiation of GDC-0349
• Treatment with an investigational agent within 4 weeks prior to initiation of GDC-0349
• Unresolved toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy
• Pregnancy or lactation

• 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

Scott Holden, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

Scottsdale, Arizona, United States

Toronto, Ontario, Canada

Countries

United States; Canada

Other Identifiers

MP00807

Identifier Type: OTHER

Identifier Source: secondary_id

MKI4956g

Identifier Type: -

Identifier Source: org_study_id