A Dose Finding Study of XRP6258 in Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT01755390|
Recruitment Status : Completed
First Posted : December 24, 2012
Last Update Posted : December 24, 2012
- To determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of XRP6258 when given as a weekly 1-hour intravenous (i.v.) infusion for the first 4 consecutive weeks of each 5-week treatment cycle (Day 1, Day 8, Day 15, Day 22 of each 5-week treatment cycle).
Secondary Objectives :
- To define the safety profile of the drug
- To establish the recommended dose and time interval for future Phase II trials
- To determine the pharmacokinetic (PK) profile of XRP6258 in man
- To assess the absolute oral bioavailability of XRP6258 at the i.v. recommended dose (following Protocol Amendment No. 2)
- To look for evidence of antitumor activity
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor||Drug: Cabazitaxel (XRP6258)||Phase 1|
The duration of the study will include the following periods:
- Pretreatment: 28 to 7 days before first infusion
- Treatment: Weekly for the first four consecutive weeks during 5-week treatment cycle
- Post-treatment: 3 - 4 weeks after last infusion.
Treatment may be continued until disease progression or unacceptable toxicity or patient refusal.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Dose Finding Study of XRP6258 Administered as a Weekly 1-hour Intravenous Infusion to Patients With Advanced Solid Tumors|
|Study Start Date :||October 1999|
|Actual Primary Completion Date :||August 2002|
|Actual Study Completion Date :||October 2002|
IV escalation part:
XRP6258 administered as a 1-hour IV infusion on Days 1, 8, 15 and 22 of each 5-week cycle until evidence of disease progression, unacceptable toxicity or patient's withdrawal.
Oral bioavailability part:
XRP6258 administered at the dose of 8.4 mg/m² as an oral administration on Day 1 Cycle 1 and as a weekly 1-hour i.v. infusion at the subsequent weeks of treatment. Patients receiving oral administration at Day 1, Cycle 1 are to fast for 12 hours before and 4 hours after administration.
Drug: Cabazitaxel (XRP6258)
Pharmaceutical form: infusion solution Route of administration: Intravenous
Other Name: Jevtana
- Dose-limiting toxicity [ Time Frame: Up to 35 months ]
- Maximum tolerated dose [ Time Frame: Up to 35 months ]
- Number of patients with adverse events [ Time Frame: Up to 35 months ]
- Antitumor activity [ Time Frame: Up to 35 months ]Measured by X-ray, ultrasound and/or scans
- Pharmacokinetic parameters including Cmax, AUC(0-t), AUC, t, t1/2λz (h), Vss, CL, accumulation ratio, Tmax metabolite ratio and F (bioavailability) [ Time Frame: Up to 35 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755390
|Study Director:||Clinical Sciences & Operations||Sanofi|