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A Dose Finding Study of XRP6258 in Patients With Advanced Solid Tumors

NCT01755390 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2012-12-24

No results posted yet for this study

Summary

Primary Objective:

\- 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

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

Cabazitaxel (XRP6258)

Pharmaceutical form: infusion solution Route of administration: Intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-10-31
Primary Completion
2002-08-31
Completion
2002-10-31

Countries

  • France
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01755390 on ClinicalTrials.gov