Evaluating the Safety and Tolerability of GDC-0349 in Patients With Locally Advanced or Metastatic Solid Tumors or Non Hodgkin's Lymphoma
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A
|
Drug: GDC-0349
Oral escalating dose
|
Outcome Measures
Primary Outcome Measures
- Incidence of dose limiting toxicities (DLTs) by NCI CTCAE v4.0 grade and associated dose of GDC-0349 [Up to 30 days]
Secondary Outcome Measures
- Incidence of adverse events by NCI CTCAE v4.0 grade and associated dose of GDC-0349 [Up to 2 years]
- Incidence of Grade 3 and 4 abnormalities in safety related laboratory parameters and associated dose of GDC-0349 [Up to 30 days]
Eligibility Criteria
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
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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
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Life expectancy of >= 12 weeks
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Adequate hematologic and organ function within 14 days prior to initiation of study treatment
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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
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Willingness to provide archival tumor tissue
Exclusion Criteria:
-
Leptomeningeal disease as the only manifestation of the current malignancy
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History of Type 1 or 2 diabetes requiring daily medication
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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
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Active congestive heart failure or ventricular arrhythmia requiring medication
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Uncontrolled ascites requiring weekly large-volume paracentesis for 3 consecutive weeks prior to initiation of study treatment
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Active infection requiring intravenous (IV) antibiotics
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Patients requiring any daily supplemental oxygen
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Uncontrolled hypomagnesemia or hypokalemia
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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
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Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
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Known human immunodeficiency virus (HIV) infection
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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
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Significant traumatic injury within 3 weeks prior to initiation of GDC-0349
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Major surgical procedure within 4 weeks prior to initiation of GDC-0349
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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.
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Palliative radiation to bony metastases within 2 weeks prior to initiation of GDC-0349
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Treatment with an investigational agent within 4 weeks prior to initiation of GDC-0349
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Unresolved toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy
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Pregnancy or lactation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Scottsdale | Arizona | United States | 85258 | |
| 2 | Toronto | Ontario | Canada | M5G 2M9 |
Sponsors and Collaborators
- Genentech, Inc.
Investigators
- Study Director: Scott Holden, M.D., Genentech, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MKI4956g
- MP00807