Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-05 @ 5:58 PM
Study NCT ID:
NCT02151357
Status:
TERMINATED
Last Update Posted:
2017-10-06
First Post:
2014-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetics of DCBCI0901 in Patients With Advanced Solid Tumor
Sponsor:
Standard Chem. & Pharm. Co., Ltd.
Organization:
Study Overview
Official Title:
Phase I, Sequential Dose Escalation Clinical Study to Investigate the Safety, Tolerability and Pharmacokinetics of in Patients With Advanced Solid Tumor
Status:
TERMINATED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
catheter occlusion events during the study drug infusion
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
* Investigate the safety and tolerability of multiple DCBCI0901 infusions in patients with advanced solid tumor
* Pharmacokinetic parameters will be calculated for DCBCI0901, if data permit.
* Anti tumor activity: The efficacy endpoint will be the overall response rate (ORR) defined as the proportion of patients who continuously receive treatment after Cycle 1 with a best overall response of complete response (CR) or partial response (PR).
* Pharmacokinetic parameters will be calculated for DCBCI0901, if data permit.
* Anti tumor activity: The efficacy endpoint will be the overall response rate (ORR) defined as the proportion of patients who continuously receive treatment after Cycle 1 with a best overall response of complete response (CR) or partial response (PR).
Detailed Description:
This is a Phase I, open label, first in human study designed to evaluate the safety, tolerability and PK of escalating doses of DCBCI0901 in patients with advanced solid tumors. Each treatment cycle will be 28 days in duration with no gap between cycles. During each cycle, DCBCI0901 will be administered slowly as a 30 minute intravenous (IV) infusion (use of infusion pump preferred) once daily (QD) in the first 5 day dosing period (Days 1 to 5), which will be followed by 9 days of recovery and observation (Days 6 14). DCBCI0901 will be administered intravenously QD in a second 5 day dosing period (Days 15 through 19), followed again by 9 days of recovery and observation (Days 20 through 28).
Patients may continue to receive treatment in 28 day cycles after completion of Cycle 1. To qualify for continued treatment beyond Cycle 1, all of the following criteria must be fulfilled:
* The patient is willing to receive further treatment
* Toxicity induced by the IP is not considered to be unbearable as judged by the Investigator
* The patient does not have PD as defined by Response Evaluation Criteria in Solid Tumors
* The patient satisfies the criteria for dosing
* The patient does not meet any of the criteria for withdrawal
After the first cycle, CT/MRI assessment will be performed once every 8 weeks (2 cycles) for efficacy evaluation, or per Investigator judgment. After the first year of treatment, the Investigator will assess the patient using CT/MRI based on his/her discretion.
Safety data will be evaluated according to normal practice.
Upon discontinuation of study treatment (if applicable), assessments for the Early termination visit (if discontinuation occurs in Cycle 1) or End of Treatment visit (if discontinuation occurs in Cycle 2 or onwards) should occur within 3 days of discontinuation. Assessments for the Follow up visit (10 days \[±1 day\] after the last dose of IP) and End of Study (EOS) visit (30 days \[±3 days\] after the last dose of IP)
Patients may continue to receive treatment in 28 day cycles after completion of Cycle 1. To qualify for continued treatment beyond Cycle 1, all of the following criteria must be fulfilled:
* The patient is willing to receive further treatment
* Toxicity induced by the IP is not considered to be unbearable as judged by the Investigator
* The patient does not have PD as defined by Response Evaluation Criteria in Solid Tumors
* The patient satisfies the criteria for dosing
* The patient does not meet any of the criteria for withdrawal
After the first cycle, CT/MRI assessment will be performed once every 8 weeks (2 cycles) for efficacy evaluation, or per Investigator judgment. After the first year of treatment, the Investigator will assess the patient using CT/MRI based on his/her discretion.
Safety data will be evaluated according to normal practice.
Upon discontinuation of study treatment (if applicable), assessments for the Early termination visit (if discontinuation occurs in Cycle 1) or End of Treatment visit (if discontinuation occurs in Cycle 2 or onwards) should occur within 3 days of discontinuation. Assessments for the Follow up visit (10 days \[±1 day\] after the last dose of IP) and End of Study (EOS) visit (30 days \[±3 days\] after the last dose of IP)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: