Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003755
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
1999-11-01
Brief Title:
Ro 31-7453 in Treating Patients With Locally Advanced or Metastatic Solid Tumor
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase I Study of R031-7453 a Novell Cell Cycle Inhibitor Administered as Escalating Oral Doses in Adults With Solid Tumors 4-Day Schedule
Status:
COMPLETED
Status Verified Date:
2013-06
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of Ro 31-7453 in treating patients who have locally advanced or metastatic solid tumor
PURPOSE Phase I trial to study the effectiveness of Ro 31-7453 in treating patients who have locally advanced or metastatic solid tumor
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of Ro 31-7453 in patients with solid tumors II Determine the toxicity of Ro 31-7453 in this patient population III Evaluate the pharmacokinetics and major metabolites of Ro 31-7453 in these patients IV Assess any antitumor activity of Ro 31-7453 in these patients
OUTLINE This is a dose escalation study Patients are treated on one of two treatment arms In the first stage cohorts of 1 patient each on arm I receive oral Ro 31-7453 twice daily on days 1-4 and cohorts of 1 patient each on arm II receive oral Ro 31-7453 once daily on days 1-4 at two dose levels higher than for arm I Dose escalation ceases for each arm with the first instance of dose limiting toxicity DLT Two additional patients are entered at the stopping dose for each arm If no further DLT occurs the study proceeds to the second stage In the second stage dose escalation continues in increments of one dose level for each dosing schedule arms I and II Cohorts of 3-6 patients receive escalating doses of Ro 31-7453 in the absence of DLT If 2 of 6 patients experience DLT at a dose level escalation ceases and the maximum tolerated dose is defined as the previous dose level Treatment continues every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity After completion of the 8 courses patients may continue treatment until disease progression at the discretion of the investigator and the study sponsor Patients are followed at 4 weeks
PROJECTED ACCRUAL A maximum of 40 patients will be accrued for this study over 18 months
OUTLINE This is a dose escalation study Patients are treated on one of two treatment arms In the first stage cohorts of 1 patient each on arm I receive oral Ro 31-7453 twice daily on days 1-4 and cohorts of 1 patient each on arm II receive oral Ro 31-7453 once daily on days 1-4 at two dose levels higher than for arm I Dose escalation ceases for each arm with the first instance of dose limiting toxicity DLT Two additional patients are entered at the stopping dose for each arm If no further DLT occurs the study proceeds to the second stage In the second stage dose escalation continues in increments of one dose level for each dosing schedule arms I and II Cohorts of 3-6 patients receive escalating doses of Ro 31-7453 in the absence of DLT If 2 of 6 patients experience DLT at a dose level escalation ceases and the maximum tolerated dose is defined as the previous dose level Treatment continues every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity After completion of the 8 courses patients may continue treatment until disease progression at the discretion of the investigator and the study sponsor Patients are followed at 4 weeks
PROJECTED ACCRUAL A maximum of 40 patients will be accrued for this study over 18 months
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 |
|---|---|---|---|
| CDR0000066879 | REGISTRY | None | None |
| NCI-G99-1499 | Registry Identifier | PDQ Physician Data Query | None |
| ROCHE-NO15857A | None | None | None |