Non-Hodgkin's Lymphoma, Solid Tumor Clinical Trial
Official title:
An Open-Label, Phase I, Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0349 in Patients With Locally Advanced or Metastatic Solid Tumors or Non Hodgkin's Lymphoma
| Verified date | November 2016 |
| Source | Genentech, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | December 2012 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Genentech, Inc. |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of dose limiting toxicities (DLTs) by NCI CTCAE v4.0 grade and associated dose of GDC-0349 | Up to 30 days | No | |
| Secondary | Incidence of adverse events by NCI CTCAE v4.0 grade and associated dose of GDC-0349 | Up to 2 years | No | |
| Secondary | Incidence of Grade 3 and 4 abnormalities in safety related laboratory parameters and associated dose of GDC-0349 | Up to 30 days | No |