A Study to Evaluate the Effects of Combining Cabazitaxel With Cisplatin Given Every 3 Weeks in Patients With Advanced Solid Cancer
A Dose-Escalation Study Of The Safety, Tolerability, And Pharmacokinetics Of Cabazitaxel In Combination With Cisplatin Administered Every 3 Weeks In Subjects With Advanced Solid Malignancies
1 other identifier
interventional
76
1 country
7
Brief Summary
This study is designed as a phase 1, multicenter, open-label, single arm, dose-escalation, study of Cabazitaxel in combination with cisplatin, to determine safety, pharmacokinetics (PK), and efficacy in solid tumors (parts 1 and 2) and single sequence, two-treatment, crossover studies to determine the effect of strong CYP3A4 inhibition and induction on the PK of Cabazitaxel in patients with solid tumors (part 3 and part 4, respectively). There are 4 parts to the study: Part 1: Determine the Dose Limiting Toxicities (DLT)'s and Maximum Tolerated Dose (MTD) based on safety. Part 2: Determine the anti-tumor activity of the combination regimen at the Maximum Tolerated Dose (MTD) in an extended cohort of patients. Part 3: Determine the effect of a strong CYP3A4 inhibitor (ketoconazole) on the pharmacokinetic (PK) of Cabazitaxel. Part 4: Determine the effect of a strong CYP3A4 inducer (rifampin) on the pharmacokinetic (PK) of Cabazitaxel.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2009
Typical duration for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 19, 2009
CompletedFirst Posted
Study publicly available on registry
June 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMay 16, 2013
May 1, 2013
3.8 years
June 19, 2009
May 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Dose Limiting Toxicities (DLT)'s of the combination of cabazitaxel and cisplatin (part 1)
first cycle (i.e.3 weeks)
Objective response ratio (Complete response (CR) and partial response (PR)) (part 2)
up to 6 cycles, ie 18 weeks
Pharmacokinetics (PK) of cabazitaxel (part 3 and 4)
up to 6 cycles, ie 18 weeks
Secondary Outcomes (3)
Time to progression (TTP) (part 1 and 2)
up to 6 cycles, ie 18 weeks
Duration of response (DR) (Part 1 and 2)
up to 6 cycles, ie 18 weeks
Cabazitaxel pharmacokinetic (part 1 and 2)
up to 6 cycles, ie 18 weeks
Study Arms (1)
1
EXPERIMENTAL* 5, 15, 20 or 25 mg/m2 * one injection of cabazitaxel on day 1 of each cycle (3 weeks)
Interventions
Eligibility Criteria
You may qualify if:
- confirmed metastatic or unremovable advanced solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist, but for which cisplatin based therapy is appropriate
- signed informed consent
You may not qualify if:
- limited physical functioning (as evaluated by the Eastern Cooperative Oncology Group (ECOG) scale)
- inability to follow study requirements and schedule
- treatment of cancer within 3 weeks of study, concurrent treatment in another clinical trial or with any other cancer therapy
- serious medical illness at same time of study and/or significantly abnormal lab reports
- lack of pregnancy contraception (women of childbearing potential), pregnancy, or breast feeding.
- Women of childbearing potential not protected by highly effective contraceptive method of birth control OTHER than hormonal contraception (Part 4 only).
- prior significant hearing or kidney problems
- continued toxic effects of prior chemotherapy
- cancers that cannot be physically measured (Part 2 only)
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (7)
Investigational Site Number 840008
Los Angeles, California, 90048, United States
Investigational Site Number 840003
San Diego, California, 92123, United States
Investigational Site Number 840010
Decatur, Illinois, 62526, United States
Investigational Site Number 840002
Baltimore, Maryland, 21201, United States
Investigational Site Number 840006
St Louis, Missouri, 63110, United States
Investigational Site Number 840007
Cincinnati, Ohio, 45267-0542, United States
Investigational Site Number 840005
San Antonio, Texas, 78229, United States
Related Publications (1)
Lockhart AC, Sundaram S, Sarantopoulos J, Mita MM, Wang-Gillam A, Moseley JL, Barber SL, Lane AR, Wack C, Kassalow L, Dedieu JF, Mita AC. Phase I dose-escalation study of cabazitaxel administered in combination with cisplatin in patients with advanced solid tumors. Invest New Drugs. 2014 Dec;32(6):1236-45. doi: 10.1007/s10637-014-0145-y. Epub 2014 Aug 13.
PMID: 25117475DERIVED
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2009
First Posted
June 22, 2009
Study Start
June 1, 2009
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
May 16, 2013
Record last verified: 2013-05