evaluating the safety and tolerability of gdc-0349 in patients with locally advanced or metastatic solid tumors or non hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma, Solid Tumor

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).


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

Keywords: solid cancers