Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00316953
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
2006-04-19
Brief Title:
Dasatinib in Treating Young Patients With Recurrent or Refractory Solid Tumors or Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Did Not Respond to Imatinib Mesylate
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of BMS-354825 Dasatinib in Children With RecurrentRefractory Solid Tumors or Imatinib Resistant Ph Leukemia BMS Trial CA180038
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial is studying the side effects and best dose of dasatinib in treating young patients with recurrent or refractory solid tumors or Philadelphia chromosome-positive acute lymphoblastic leukemia or chronic myelogenous leukemia that did not respond to imatinib mesylate Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I Determine the toxicities and estimate the maximum tolerated dose or the recommended phase 2 dose of dasatinib in pediatric patients with refractory solid tumors
II Determine the toxicities of dasatinib in pediatric patients with imatinib mesylate-resistant Philadelphia chromosome-positive Ph leukemia
III Characterize the pharmacokinetics of dasatinib in pediatric patients with refractory solid tumors or imatinib-resistant Ph leukemia
SECONDARY OBJECTIVES
I Preliminarily define the antitumor activity of dasatinib in pediatric patients with refractory solid tumors within the confines of a phase I study
II Obtain pilot data on the activity of dasatinib administered in pediatric patients with Ph leukemia
III Assess the biologic activity of dasatinib on tumor cells when available IV Determine the phosphotyrosine state of SRC and ABL substrates and correlate this with dasatinib dosage and antitumor activity pharmacodynamics study
OUTLINE This is a multicenter dose-escalation study Patients are stratified according to disease solid tumors vs leukemia
Stratum 1 solid tumors Patients receive oral dasatinib twice daily on days 1-28 Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of dasatinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity DLT
Stratum 2 leukemia Patients receive dasatinib as in stratum 1 Cohorts of 3-12 patients receive escalating or de-escalating doses of dasatinib The MTD is defined as the dose preceding that at which 7 of 12 patients experience DLT
After completing study treatment patients are followed for 1 month
I Determine the toxicities and estimate the maximum tolerated dose or the recommended phase 2 dose of dasatinib in pediatric patients with refractory solid tumors
II Determine the toxicities of dasatinib in pediatric patients with imatinib mesylate-resistant Philadelphia chromosome-positive Ph leukemia
III Characterize the pharmacokinetics of dasatinib in pediatric patients with refractory solid tumors or imatinib-resistant Ph leukemia
SECONDARY OBJECTIVES
I Preliminarily define the antitumor activity of dasatinib in pediatric patients with refractory solid tumors within the confines of a phase I study
II Obtain pilot data on the activity of dasatinib administered in pediatric patients with Ph leukemia
III Assess the biologic activity of dasatinib on tumor cells when available IV Determine the phosphotyrosine state of SRC and ABL substrates and correlate this with dasatinib dosage and antitumor activity pharmacodynamics study
OUTLINE This is a multicenter dose-escalation study Patients are stratified according to disease solid tumors vs leukemia
Stratum 1 solid tumors Patients receive oral dasatinib twice daily on days 1-28 Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of dasatinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity DLT
Stratum 2 leukemia Patients receive dasatinib as in stratum 1 Cohorts of 3-12 patients receive escalating or de-escalating doses of dasatinib The MTD is defined as the dose preceding that at which 7 of 12 patients experience DLT
After completing study treatment patients are followed for 1 month
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000467233 | REGISTRY | PDQ Physician Data Query | None |
| ADVL0516 | None | None | None |
| U10CA97452 | OTHER_GRANT | None | None |