Clinical trial · Interventional
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0425 Administered With and Without Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma
An Open-Label, Phase I, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0425 Administered With and Without Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma
NCT01359696CI-TRIAL-00026947completedPhase 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, pharmacokinetics (PK), and pharmacodynamics (PD) of GDC-0425 administered with and without gemcitabine.
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 Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GDC-0425 | Drug | — | UNRESOLVED |
| gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: GDC-0425
- Drug: gemcitabine
Primary outcomes (6)
- measure
- Incidence of all adverse events graded according to NCI CTCAE, v4.0
- timeFrame
- Up to 1 year
- measure
- Incidence of dose limiting toxicities (DLTs)
- timeFrame
- Up to 35 days
- measure
- Pharmacokinetic property of GDC-0425: determination of plasma drug concentration
- timeFrame
- Up to 12 months or early study discontinuation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1 * Signed Informed Consent Form * 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 * Adequate hematologic and end-organ (liver and kidney) function * For female patients of childbearing potential and male patients with partners of childbearing potential, agreement by the patient that the patient and/or partner will use an effective form of contraception * Patients enrolled in certain phases must be willing to provide fresh and/or archival tumor samples Exclusion Criteria: * History of prior significant toxicity from a same class of agents as GDC-0425 or gemcitabine requiring discontinuation of treatment * Allergy, hypersensitivity or contraindication to the GDC-0425 formulation or gemcitabine * Experimental therapy or anti-cancer therapy within 4 weeks prior to the first dose of study drug treatment * Radiotherapy within 2 weeks prior to first dose of study drug treatment * More than two regimens of cytotoxic chemotherapy for the treatment of locally advanced or metastatic cancer * History of receiving high-dose chemotherapy requiring bone marrow or stem cell support * History of receiving radiation to more than 25% of bone marrow-bearing areas * Acute drug-related toxicities from previous therapies have not resolved prior to study entry, except for alopecia and mild neuropathy * Current severe, uncontrolled systemic disease (including but not limited to clinically significant cardiovascular, pulmonary, or renal disease or ongoing or active infection) excluding cancer * Significant heart disease and heart dysfunction including but not limited to uncontrolled severe hypertension, heart failure, and reduced cardiac contractility * Uncontrolled ascites, due to diseases other than cancer * Inability or unwillingness to swallow pills/capsules * History of malabsorption or other condition that would interfere with drug absorption * Any history of active stomach and/or intestine bleeding within the 6 months prior to screening * Known HIV infection * Pregnancy, lactation, or breastfeeding * Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms * Inability to comply with study and follow up procedures
References
Publications (0)
Data not yet available
No reference posted for this study.