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Phase I Study of CBP501 and Cisplatin in Patients With Advanced Refractory Solid Tumors

NCT00551512 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-03-14

No results posted yet for this study

Summary

The purpose of this research study is to find the answers to the following questions:

1. 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?
2. What are the side effects of the combination of CBP501 and cisplatin when given as an infusion every 21 days?
3. What amount of CBP501 and cisplatin are found in the blood at certain times after it is given?
4. Are there any substances in your blood or tumor that can tell us about tumor sensitivity to CBP501 and cisplatin?
5. Will CBP501 given with cisplatin help to treat your cancer?

Conditions

Interventions

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.

Sponsors & Collaborators

  • CanBas Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Ernesto Wasserman, MD · AAIOncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2009-05-31
Completion
2009-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00551512 on ClinicalTrials.gov