Dose-Escalation, Safety, Pharmacokinetics Study of Cabazitaxel With Gemcitabine In Patients With Solid Tumor
| Status: | Archived |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | November 2009 |
| End Date: | June 2013 |
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:
- 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.
- 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,
and 2,2 difluoridine 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.
- To assess the potential inhibitory effect of cabazitaxel on CYP3A4 using midazolam, a
CYP3A4 probe since cabazitaxel inhibits CYP3A4 in vitro.
The study consists of a screening phase (maximum length of 21-day), a treatment phase with
21-day study treatment cycles. Cycle lengths may be extended up to maximum of 2 additional
weeks in case of unresolved toxicity. Patients will be treated until disease progression or
unacceptable toxicities, withdrawal of consent or Investigator's decision.There will be a
30-day follow-up visit after the last dose of study medication. Patients who discontinue
study treatment prior to disease progression will continue to have tumor assessments every 6
weeks until disease progression or start of an other anticancer therapy.
The cut off date for the study is defined as follows: all patients will be followed up until
disease progression, unacceptable toxicity, consent withdrawal or when the last patient had
completed 26 weeks or 6 cycles on study treatment, whichever comes first. Patients may
continue to be treated on study as long as they are benefiting from study treatment and have
not met study withdrawal criteria. After withdrawal from study treatment, further treatment,
if any, is at the discretion of the Investigator.
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