Clinical trial · Interventional
Evaluating the Safety and Tolerability of GDC-0349 in Patients With Locally Advanced or Metastatic Solid Tumors or Non Hodgkin's Lymphoma
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
NCT01356173CI-TRIAL-00024579completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Hodgkin's Lymphoma, Solid Tumor | Non-Hodgkin Lymphoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GDC-0349 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: GDC-0349
Primary outcomes (1)
- measure
- Incidence of dose limiting toxicities (DLTs) by NCI CTCAE v4.0 grade and associated dose of GDC-0349
- timeFrame
- Up to 30 days
Secondary outcomes (2)
- measure
- Incidence of adverse events by NCI CTCAE v4.0 grade and associated dose of GDC-0349
- timeFrame
- Up to 2 years
- measure
- Incidence of Grade 3 and 4 abnormalities in safety related laboratory parameters and associated dose of GDC-0349
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.