Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Cancer | Malignant Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cabazitaxel (XRP6258) | Drug | Cabazitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- * 5, 15, 20 or 25 mg/m2 * one injection of cabazitaxel on day 1 of each cycle (3 weeks)
- interventionNames
- Drug: cabazitaxel (XRP6258)
Primary outcomes (3)
- measure
- Dose Limiting Toxicities (DLT)'s of the combination of cabazitaxel and cisplatin (part 1)
- timeFrame
- first cycle (i.e.3 weeks)
- measure
- Objective response ratio (Complete response (CR) and partial response (PR)) (part 2)
- timeFrame
- up to 6 cycles, ie 18 weeks
- measure
- Pharmacokinetics (PK) of cabazitaxel (part 3 and 4)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * 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 Exclusion criteria * 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.
References
Publications (1)
- DERIVEDLockhart 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 25117475