Dose-Escalation, Safety, Pharmacokinetics Study of Cabazitaxel With Gemcitabine In Patients With Solid Tumor
Status:
Terminated
Trial end date:
2011-10-01
Target enrollment:
Participant gender:
Summary
Primary Objectives:
- Study part 1: To determine the Maximum Tolerated Dose (MTD) and the Dose Limiting
Toxicities (DLTs) of cabazitaxel administered as a 1-hour infusion in combination with
gemcitabine, every 3 weeks in patients with advanced solid malignancies.
- Study part 2: To determine the antitumor activity of cabazitaxel in combination with
gemcitabine, in an additional extended cohort of 15 patients with advanced solid
malignancies treated with the defined MTD, as assessed by objective response rate (ORR)
according to the revised guideline for Response Evaluation Criteria in Solid Tumours
(RECIST 1.1 criteria).
Secondary Objectives:
- To assess the safety profile of the combination regimen of cabazitaxel with gemcitabine.
- To assess the pharmacokinetics (PK) of cabazitaxel, gemcitabine and its metabolite 2',2'
difluorodeoxyuridine (dFdU) when given in combination.
- To determine Time to Progression (TTP), Objective Response Rate (ORR), and Duration of
Response (DR), in the extended cohort of patients treated at the MTD in Part 2 of the
study and the patients who received the MTD in Part 1 component.
For study part 1, dose levels were to be escalated according to predefined dose escalation
decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at
least 2 patients developed a DLT during the first 3 weeks of treatment. There was no further
dose escalation when this dose was achieved. The MTD was defined as the highest dose at which
0 or 1 of 3 to 6 patients, respectively, experienced DLT during the first 3 weeks of
treatment.