Neoplasms, Malignant Clinical Trial
Official title:
An Open-label, Dose-escalation, Safety and Pharmacokinetics Phase I Study of Ombrabulin in Combination With Docetaxel and Cisplatin Every 3 Weeks in Patients With Advanced Solid Tumors
Primary Objective:
- To determine the maximum tolerated dose based on the incidence of dose limiting
toxicity and the maximum administered dose of ombrabulin in combination with docetaxel
and cisplatin administered every 3 weeks in patients with advanced solid tumors
Secondary Objectives:
- To assess the overall safety profile of the combination therapy
- To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR
258063, docetaxel and cisplatin in combination.
- To evaluate anti-tumor activity of the combination therapy
The duration of the study for each patient will include an up to 4-week screening phase, 21-day study treatment cycles, an end of treatment visit and a follow-up period 30 days after the last infusion of ombrabulin. The patient will continue treatment until disease progression, unacceptable toxicity, patient's refusal of further treatment. ;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01193595 -
Dose-escalation, Safety, Pharmacokinetics Study of AVE8062 Combined With Bevacizumab in Patients With Advanced Solid Tumors
|
Phase 1 | |
Terminated |
NCT01001221 -
Dose-Escalation, Safety, Pharmacokinetics Study of Cabazitaxel With Gemcitabine In Patients With Solid Tumor
|
Phase 1/Phase 2 | |
Completed |
NCT01087021 -
Effect of Cabazitaxel on the QTc Interval in Cancer Patients
|
Phase 1 | |
Completed |
NCT01021150 -
Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Cisplatin in Patients With Solid Tumors
|
Phase 1 | |
Suspended |
NCT00868647 -
Radiofrequency Ablation (RFA) Of Tumors Acquired In Childhood
|
Phase 2 | |
Completed |
NCT01063946 -
A Study to Investigate the Disposition of Radio-labeled AVE8062 Compound Administered as a 30-minute IV Infusion to Patients With Advanced Solid Tumor
|
Phase 1 | |
Terminated |
NCT02706197 -
Oxygen Measurements in Subcutaneous Tumors by EPR Oximetry Using OxyChip
|
N/A | |
Terminated |
NCT03321903 -
EPR Tumor Oximetry With CE India Ink
|