Clinical trial · Interventional
Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors
Phase I Study of the Non-receptor Kinase Inhibitor Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic 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 study will determine the maximum-tolerated dose (MTD) for oral bosutinib when used in combination with pemetrexed. The MTD is the highest dose of bosutinib with pemetrexed that can be given without causing severe side effects. This study will also test the safety of this combination and see what effects (good or bad) it has on participants and their cancer.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
| Thymoma | Thymoma | ONTOLOGY_EXACT | 0.98 |
| Thymus Cancer | Malignant Thymus Neoplasm | ALIAS | 0.90 |
| Uterine Cervical Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bosutinib | Drug | Bosutinib | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bosutinib and Pemetrexed
- description
- Bosutinib and pemetrexed
- interventionNames
- Drug: Bosutinib
- Drug: Pemetrexed
Primary outcomes (2)
- measure
- Dose-limiting toxicity of the combination of bosutinib and pemetrexed
- timeFrame
- 21 days
- description
- CTCAE Grade 3 or 4 non-hematologic toxicities other than alopecia, nausea and vomiting.
- measure
- Maximum tolerated dose of the combination of bosutinib and pemetrexed
- timeFrame
- completion of dose escalation
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically or cytologically proven advanced, metastatic non-squamous non-small cell lung cancer, pleural malignant mesothelioma, bladder or urethral cancer, ovarian cancer, primary peritoneal cancer, thymoma and thymic cancer and uterine cervical cancer. * Measurable disease * Life expectancy of greater than 3 months. * Ability to take folic acid, vitamin B12, and dexamethasone according to protocol. Exclusion Criteria: \- Untreated or symptomatic brain metastases.
References
Publications (0)
Data not yet available