Clinical trial · Interventional
A Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors
A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors
- 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 Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of oral (PO) GDC-0941 administered in combination with PO erlotinib in patients with advanced solid tumors and patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed at least one prior chemotherapy regimen.
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-Squamous Non-Small Cell Lung Cancer, Solid Cancers | Lung Non-Squamous Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib HCl | Drug | Erlotinib Hydrochloride | ALIAS |
| GDC-0941 | Drug | Pictilisib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: GDC-0941
- Drug: erlotinib HCl
Primary outcomes (2)
- measure
- Incidence, nature, and severity of adverse events
- timeFrame
- Through study completion or early study discontinuation
- measure
- Tumor response
- timeFrame
- Assessed at periodic intervals
Secondary outcomes (1)
- measure
- PK parameters of GDC-0941 (total exposure, and maximum and minimum serum concentrations)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Documented locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable (dose-escalation stage only) * Documented locally advanced or metastatic NSCLC in patients who have failed at least one prior chemotherapy-based regimen for incurable disease (cohort-expansion stage only) * Adequate organ function as assessed by laboratory tests * Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST) * Agreement to use an effective form of contraception for the duration of the study Exclusion Criteria: * Any anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe prior to first study treatment * Prior treatment with PI3K pathway-inhibiting agents (cohort-expansion stage only) * History of Grade \>= 3 fasting hyperglycemia or diabetes requiring regular medication * Current clinically significant and uncontrolled systemic disease (e.g., cardiovascular, pulmonary, or metabolic) * History of clinically significant cardiac or pulmonary dysfunction * History of malabsorption syndrome or other condition that would interfere with enteral absorption * Clinically significant history of liver disease * Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents * Active autoimmune disease and/or need for corticosteroid therapy * Known brain metastases that are untreated, symptomatic, or require therapy * Pregnancy, lactation, or breastfeeding
References
Publications (0)
Data not yet available