Clinical trial · Interventional
Pazopanib + Vinorelbine in Non Small Cell Lung Cancer (NSCLC) and Breast Cancer
Phase I Study of Pazopanib in Combination With Vinorelbine in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Breast Cancer
NCT01060514CI-TRIAL-00012488terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of timely accrual.
Summary
Brief summary (as posted)
The purpose of this study is to determine the highest dose of Vinorelbine and Pazopanib that can be given together without causing severe side effects. Also, this study will evaluate what effects (good and bad) that the treatment has on patients and their cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pazopanib | Drug | Pazopanib | ALIAS |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pazopanib + Vinorelbine
- interventionNames
- Drug: Pazopanib
- Drug: Vinorelbine
Primary outcomes (1)
- measure
- To determine the maximum tolerated dose (MTD), and the recommended Phase II dose to be used in patients with metastatic NSCLC and breast cancer.
- timeFrame
- at study completion (estimated at 2 years)
Secondary outcomes (3)
- measure
- To determine the response rate, progression free survival and overall survival in patients with metastatic NSCLC and metastatic breast cancer treated with pazopanib in combination with vinorelbine.
- timeFrame
- imaging done every 6 weeks
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years * Patients must have diagnosis of breast cancer or non small cell lung cancer * Patients must have evaluable disease * Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study. * Patients must have given signed, informed consent prior to registration on study. Exclusion Criteria: * Patients must not be pregnant and/or lactating. * Patients must not be receiving any other investigational agents. * No prior exposure to vinorelbine or other VEGF inhibitors as treatment for metastatic disease * Patients must not have received prior therapy (including radiation, surgery, and/or chemotherapy) within 30 days * History of allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib or vinorelbine. * Patients cannot have received more than 2 prior chemotherapy regimens for lung cancer or 3 prior chemotherapy regimens for breast cancer. This criterion can be discussed further with the study doctor. * Must not have uncontrolled illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmic, psychiatric illness/social situations that would limit compliance with study requirements.
References
Publications (0)
Data not yet available
No reference posted for this study.