Clinical trial · Interventional
Safety and Effectiveness of Combretastatin A-4 Phosphate Combined With Chemotherapy in Advanced Solid Tumors
A Randomized Open-Labeled Phase II Study of Combretastatin A-4 Phosphate in Combination With Paclitaxel and Carboplatin to Evaluate the Safety and Efficacy in Subjects With Advanced Imageable Malignancies
- 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 a study evaluating the safety and effectiveness of Combretastatin A4 Phosphate (CA4P) combined with the chemotherapy drugs, carboplatin and paclitaxel. The full treatment and observation time should be about 5 months. During this time the patient should receive 18 CA4P infusions and 6 carboplatin followed by paclitaxel treatments. Patients will be randomized into one of two CA4P dose-level groups in order to recommend a preferred dose-level for future studies. At least 2 dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) scans will be conducted to monitor the blood flow through the tumor before and after treatment with CA4P.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 45 mg/m2 Combretastatin A-4 Phosphate
- interventionNames
- Drug: Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin
- type
- EXPERIMENTAL
- label
- 60 mg/m2 Combretastatin A-4 Phosphate
- interventionNames
- Drug: Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin
Primary outcomes (4)
- measure
- To assess safety of the CA4P-paclitaxel-carboplatin combination in advanced imageable malignancies
- timeFrame
- From first administration of study drug through approximately 30 days following last dose of study drug
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced malignancy where treatment with carboplatin and paclitaxel is warranted. * Minimum 28-day interval from any surgical, chemotherapy or immunotherapy treatment and a 14-day interval from radiotherapy treatment. * Radiologically measurable disease to meet MRI perfusion criteria. * ECOG performance status less than or equal to 1. * Life expectancy greater than 12 weeks. * Normal ejection fraction. Exclusion Criteria: * Uncontrolled brain metastasis. * Significant cardiac abnormalities. * Prior radiotherapy at the tumor site. * Symptomatic peripheral vascular or cerebrovascular disease. * Uncontrolled hypertension.
References
Publications (0)
Data not yet available