Clinical trial · Interventional
Study of the Safety and Pharmacology of GDC-0980 in Combination With Paclitaxel With or Without Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer
A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0980 in Combination With Paclitaxel With or Without Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer
NCT01254526CI-TRIAL-00024604completedPhase 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 Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0980 administered with taxane-based chemotherapy regimens utilized in patients with locally recurrent or metastatic breast cancer.
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| GDC-0980 | Drug | Apitolisib | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: GDC-0980
- Drug: paclitaxel
- type
- EXPERIMENTAL
- label
- B
- interventionNames
- Drug: GDC-0980
- Drug: bevacizumab
- Drug: paclitaxel
Primary outcomes (2)
- measure
- Incidence and nature of dose-limiting toxicities (DLTs)
- timeFrame
- Through Day 22
- measure
- Incidence, nature, and severity of adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Locally recurrent or metastatic breast cancer, not amenable to resection with curative intent * For Arm C: Overexpression of HER2 * Eastern Cooperative Oncology Group Performance Status of 0 or 1 * Adequate hematologic and organ function * Evaluable or measurable disease per RECIST (Response Evaluable Criteria in Solid Tumors) * Female patients of childbearing potential must use an acceptable method of contraception to prevent pregnancy and to continue its use for the duration of the study Exclusion Criteria: * Prior anti-cancer therapy of more than two regimens of systemic cytotoxic chemotherapy for advanced or metastatic breast cancer * Prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe of the first dose of study treatment * History of Type 1 or Type 2 diabetes requiring regular medication * History of clinically significant cardiac or pulmonary dysfunction * History of malabsorption syndrome or other condition that would interfere with enteral absorption * Any condition requiring full-dose anticoagulants * Leptomeningeal disease as a manifestation of cancer * Active infection requiring IV antibiotics * Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs, inhaled steroids, or the equivalent of \<= 10 mg/day of prednisone * Known clinically significant history of liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis * Known HIV infection * Known untreated or active CNS metastases * Pregnancy, lactation, or breastfeeding * Major surgical procedure, open biopsy, or significant traumatic injury within a within a specified timeframe of the first dose of study treatment For Arm B: * Uncontrolled hypertension, complication from hypertension, myocardial infarctions, unstable angina, vascular disease or stroke within a specified timeframe of the first dose of study treatment * Evidence of bleeding diathesis or significant coagulopathy including hemoptysis within a specified timeframe of the first dose of study treatment * History of abdominal conditions (e.g., fistula, perforation, obstruction) that would preclude use of bevacizumab * Serious, non-healing wound, active ulcer, or untreated bone fracture * Proteinuria
References
Publications (0)
Data not yet available
No reference posted for this study.