Neoplasms, Malignant Clinical Trial
Official title:
A Dose-Escalation, Single Arm, Combination Study of Cabazitaxel With Gemcitabine to Determine The Safety, And Pharmacokinetics In Subjects With Advanced Solid Malignancies
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.
The study consisted of a screening phase (maximum length of 21-day), a treatment phase with
21-day treatment cycles and a 30-day follow-up visit after the last dose of study
medication.
The cut-off date for study part 1 was when last participant completed the first treatment
cycle and the subsequent 30 days follow-up.
The cut off date for study part 2 was when all participants experienced disease progression,
unacceptable toxicity, consent withdrawal or the last participant had completed 26 weeks or
6 cycles on study treatment, whichever came first.
Participants could continue to be treated on study as long as they were benefiting from
study treatment and had not met study withdrawal criteria. After withdrawal from study
treatment, further treatment, if any, was at the discretion of the Investigator.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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