Phase I Clinical and Pharmacokinetic (PK) Study of CBP501 and Cisplatin Every 3 Weeks in Patients With Advanced Refractory Solid Tumors
This study has been completed.
CanBas Co. Ltd.
Information provided by:
CanBas Co. Ltd.
First received: October 29, 2007
Last updated: October 31, 2011
Last verified: October 2011
The purpose of this research study is to find the answers to the following questions:
- What are the highest doses of CBP501 and cisplatin that can be safely administered as consecutive 2-hours and 1-hour infusions every 21 days?
- What are the side effects of the combination of CBP501 and cisplatin when given as an infusion every 21 days?
- What amount of CBP501 and cisplatin are found in the blood at certain times after it is given?
- Are there any substances in your blood or tumor that can tell us about tumor sensitivity to CBP501 and cisplatin?
- Will CBP501 given with cisplatin help to treat your cancer?
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Clinical and Pharmacokinetic Study of CBP501 and Cisplatin Every 3 Weeks in Patients With Advanced Refractory Solid Tumors|
Resource links provided by NLM:
Further study details as provided by CanBas Co. Ltd.:
Primary Outcome Measures:
- Dose Limiting Toxicity (DLT) during the first two treatment cycles [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Incidence and severity of adverse events and laboratory abnormalities, graded according to NCI-CTCAE version 3.0 [ Time Frame: During and at end of study ] [ Designated as safety issue: Yes ]
- Occurrence of Serious Adverse Events (SAEs) [ Time Frame: During and at end of study ] [ Designated as safety issue: Yes ]
- Occurrence of discontinuations due to treatment-related adverse events [ Time Frame: At end of study ] [ Designated as safety issue: Yes ]
- Serum concentrations of CBP501 and total and ultrafiltrate platinum to determine, via non-compartmental methods, Cmax, AUC, lz, t½, Cl and Vss. [ Time Frame: During and at end of study ] [ Designated as safety issue: No ]
- Evaluation of the relationship between administered dose and plasma pharmacokinetic parameters for CBP501 and cisplatin [ Time Frame: During and at end of study ] [ Designated as safety issue: No ]
- Objective tumor response assessed according to RECIST [ Time Frame: During and at end of study ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: During and at end of study ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Drug: CBP501 and Cisplatin
CBP501 is given IV on Day 1 of each cycle (every 21 days). Dose escalation of CBP501 and cisplatin will be starting doses of 3.6 mg/m² CBP501 and 50 mg/m² cisplatin (Dose Level 1). Step 1, if during the first 2 cycles, at least 2 out of 3 to 6 patients experience Dose Limiting Toxicity (DLT) at 50 mg/m² cisplatin, then the cisplatin dose will be de-escalated to 30 mg/m². If no more than 1 out of 6 patients experiences DLT, cisplatin dose will be escalated to 75 mg/m². Step 2, dose escalation will be performed using the cisplatin MTD, with escalating CBP501 doses. CBP501 dose escalation will take place until the MTD has been defined or 74 mg/m² is reached.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00551512
|United States, Arizona|
|Scottsdale Clinical Research Institute|
|Scottsdale, Arizona, United States, 85258|
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Nevada|
|Nevada Cancer Institute|
|Las Vegas, Nevada, United States, 89135|
Sponsors and Collaborators
CanBas Co. Ltd.
|Study Director:||Ernesto Wasserman, MD||AAIOncology|