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
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The total duration on the study per subject will be about 26 weeks broken down as follows:
- A maximum of 21-day screening phase,
- 21-days (+/- 2 weeks) study treatment cycles,
- 30-day follow-up visit after the last dose of study medication.
- Cut-off date for parts 1, 2, 3 and 4: when the last patient has completed 6 cycles (parts 1 and 2) or 2 cycles (parts 3 and 4) of treatment or discontinued study treatment (for disease progression, unacceptable toxicity, withdrawal of consent, or investigator's decision to withdraw), whichever comes first, in the corresponding part.
Patients still receiving treatment at the cut-off date may continue to receive treatment beyond the cut-off date at investigator's discretion if benefiting.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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California
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Los Angeles, California, États-Unis, 90048
- Investigational Site Number 840008
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San Diego, California, États-Unis, 92123
- Investigational Site Number 840003
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Illinois
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Decatur, Illinois, États-Unis, 62526
- Investigational Site Number 840010
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Maryland
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Baltimore, Maryland, États-Unis, 21201
- Investigational Site Number 840002
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Missouri
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St Louis, Missouri, États-Unis, 63110
- Investigational Site Number 840006
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Ohio
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Cincinnati, Ohio, États-Unis, 45267-0542
- Investigational Site Number 840007
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Texas
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San Antonio, Texas, États-Unis, 78229
- Investigational Site Number 840005
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 1
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Dose Limiting Toxicities (DLT)'s of the combination of cabazitaxel and cisplatin (part 1)
Délai: first cycle (i.e.3 weeks)
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first cycle (i.e.3 weeks)
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Objective response ratio (Complete response (CR) and partial response (PR)) (part 2)
Délai: up to 6 cycles, ie 18 weeks
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up to 6 cycles, ie 18 weeks
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Pharmacokinetics (PK) of cabazitaxel (part 3 and 4)
Délai: up to 6 cycles, ie 18 weeks
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up to 6 cycles, ie 18 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Time to progression (TTP) (part 1 and 2)
Délai: up to 6 cycles, ie 18 weeks
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up to 6 cycles, ie 18 weeks
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Duration of response (DR) (Part 1 and 2)
Délai: up to 6 cycles, ie 18 weeks
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up to 6 cycles, ie 18 weeks
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Cabazitaxel pharmacokinetic (part 1 and 2)
Délai: up to 6 cycles, ie 18 weeks
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up to 6 cycles, ie 18 weeks
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- TCD10870
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