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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
CanBas Co. Ltd.
Study ID
NCT00551512
Phase
PHASE1
Status
Completed

Conditions

  • Cancer
  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CBP501 and Cisplatin — DRUG
    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.

Study Details

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?

Key Dates

Start date
Nov 30, 2006
Status verified
Mar 2017
Primary completion
May 31, 2009
Completion
May 31, 2009

Study Design

Enrollment
48 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CBP501 and Cisplatin
    Dose escalation study

Primary Outcome Measure

Dose Limiting Toxicity (DLT) during the first two treatment cycles [ Time Frame: 6 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Scottsdale Clinical Research InstituteScottsdaleArizona85258-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Nevada Cancer InstituteLas VegasNevada89135-

Find similar trials in Scottsdale, AZ

By research site
Scottsdale Clinical Research Institute· Scottsdale, AZDana Farber Cancer Institute· Boston, MANevada Cancer Institute· Las Vegas, NV

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