Clinical trial · Interventional
A Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0917 Administered to Patients With Refractory Solid Tumors or Lymphoma
An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0917 Administered Daily in Patients With Refractory Solid Tumors or Lymphoma
NCT01226277CI-TRIAL-00024694completedPhase 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 designed to assess the safety, tolerability, and pharmacokinetics (PK) of GDC-0917 in patients with refractory solid tumors or lymphoma.
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 |
|---|---|---|---|
| Solid Cancers | Malignant Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GDC-0917 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: GDC-0917
Primary outcomes (3)
- measure
- Changes in vital signs, ECGs, and clinical laboratory results
- timeFrame
- Throughout study or until early discontinuation
- measure
- Incidence and nature of dose-limiting toxicities and adverse events of special interest
- timeFrame
- Throughout study or until early discontinuation
- measure
- Incidence, nature, and severity of all adverse events and serious adverse events
- timeFrame
- Throughout study or until early discontinuation
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically documented, locally advanced or metastatic solid tumors or lymphoma for which standard therapy either does not exist or has proven ineffective or intolerable * Life expectancy \>/= 12 weeks * Adequate hematologic and end organ function * For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use an effective form of contraception and to continue its use for the duration of the study. Exclusion Criteria: * Clinically significant history of chronic liver disease, active hepatic infection, evidence of hepatic cirrhosis or Grade \>/= 2 liver dysfunction not due to hepatic metastases of cancer, current alcohol abuse, active infections with hepatitis B virus, or hepatitis C virus * Grade \>/= 2 fever or associated constitutional symptoms, or a clinically significant systemic infection within the last month * Autoimmune disease * History of clinically significant pulmonary disease * Need for chronic and continuous systemic or topical corticosteroids or immunosuppressive therapy within 2 weeks prior to study entry or anticipated need of continuous systemic corticosteroids or immunosuppressive therapy during study participation. * Allergy or hypersensitivity to components of the GDC-0917 formulation * Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in Cycle 1 * Experimental therapy within 4 weeks prior to first dose of study drug treatment in Cycle 1 * Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug treatment in Cycle 1, or anticipation of the need for major surgery during the course of study treatment * Prior anti-cancer therapy within 4 weeks before the first dose of study drug treatment in Cycle 1 * All acute drug-related toxicities must have resolved prior to study entry, except for alopecia and Grade 1 neuropathy * Current severe, uncontrolled systemic disease excluding cancer * History of clinically significant cardiac dysfunction * History of malabsorption or other condition that would interfere with enteral absorption * Any history of active GI bleeding within the past 6 months prior to screening * Known HIV infection * Uncontrolled ascites, due to diseases other than cancer, requiring weekly large-volume paracentesis for 3 consecutive weeks prior to enrollment * Pregnancy, lactation, breastfeeding or unwillingness to use birth control during the study and for 3 months after the last dose of GDC-0917 * Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
References
Publications (0)
Data not yet available
No reference posted for this study.