Clinical trial · Interventional
A Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of GDC-0032 in Combination With Docetaxel or With Paclitaxel in Patients With HER2-negative Locally Recurrent or Metastatic Breast Cancer or Non-small Cell Lung Cancer
- 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, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0032 administered in combination with either docetaxel or with paclitaxel. Patients treated with the GDC-0032 and docetaxel have HER2-negative locally recurrent or metastatic breast cancer or non-small cell lung cancer (NSCLC). Patients treated with the GDC-0032 and paclitaxel combination have human epidermal growth factor receptor 2 (HER2)-negative locally recurrent or metastatic breast cancer. There are two potential stages within each arm of this study: a dose-escalation stage (Stage 1) and a dose-expansion stage (Stage 2). Once the maximum tolerated dose of GDC-0032 in a given arm has been established from dose escalation, additional patients with each combination will be enrolled in Stage 2.
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 |
|---|---|---|---|
| Breast Cancer, Non-small Lung Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| GDC-0032 | Drug | Taselisib | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Arm A: GDC-0032 + Docetaxel
- description
- Participants will receive GDC-0032 once daily for 21 consecutive days (beginning from Day 1) in each 21-day cycle along with Docetaxel on Day 1 of each 21-day cycle.
- interventionNames
- Drug: Docetaxel
- Drug: GDC-0032
- type
- EXPERIMENTAL
- label
- Arm B: GDC-0032 + Paclitaxel
- description
- Participants will receive GDC-0032 once daily for 28 consecutive days (beginning from Day 1) in each 28-day cycle along with Paclitaxel on Days 1, 8, 15 and 22 of each 28-day cycle.
- interventionNames
- Drug: GDC-0032
- Drug: Paclitaxel
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>=18 years * For paclitaxel combination arms: histologically or cytologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease * For docetaxel combination arms: histologically or cytologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease or histologically documented advanced (Stage IV) or recurrent NSCLC * For participants with breast cancer: HER2-negative disease as defined by local clinical guidelines * Participants with NSCLC to be treated with docetaxel need to have received at least one prior anti-cancer treatment regimen in an advanced setting and to have docetaxel be considered appropriate treatment * Evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) v.1.1 * Life expectancy \>=12 weeks * Eastern cooperative oncology group (ECOG) performance status of 0 or 1 at screening * Adequate hematologic and end organ function * Use of highly effective form of contraception Exclusion Criteria: * Prior anti-cancer therapy * Prior treatment with phosphoinositide 3-kinase (PI3K) inhibitor * Known significant hypersensitivity to any components of study treatment * Grade \>=2 peripheral neuropathy * Type 1 or Type 2 diabetes * Grade \>=2 hypercholesterolemia or hypertriglyceridemia * Congenital long QT syndrome * Active congestive heart failure or ventricular arrhythmia
References
Publications (0)
Data not yet available