Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014365
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2001-04-10
Brief Title:
Ro 31-7453 in Treating Patients With Metastatic Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
The Food-Effect Bioavailability Study of Ro 31-7453 a Novel Cell Cycle Inhibitor in Stable Patient Volunteers With Solid Tumors
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 Randomized phase I trial to determine if Ro 31-7453 is more effective with or without food in treating patients who have metastatic solid tumors
PURPOSE Randomized phase I trial to determine if Ro 31-7453 is more effective with or without food in treating patients who have metastatic solid tumors
Detailed Description:
OBJECTIVES I Assess the impact of food on the bioavailability of Ro 31-7453 in patients with locally advanced or metastatic solid tumors
OUTLINE This is a randomized crossover study Patients are randomized to one of two treatment arms Arm I Patients receive oral Ro 31-7453 under fasting conditions on day 1 After a 1-week washout period patients receive oral Ro 31-7453 under fed conditions Arm II Patients receive fed treatment as in arm I on day 1 After a 1-week washout period patients receive fasted treatment as in arm I Both arms At the start of week 3 patients may continue to receive oral Ro 31-7453 every 12 hours on days 1-4 Treatment repeats every 3 weeks for at least 24 weeks in the absence of disease progression or unacceptable toxicity Patients are followed at 7 days
PROJECTED ACCRUAL A total of 10 patients 5 per arm will be accrued for this study
OUTLINE This is a randomized crossover study Patients are randomized to one of two treatment arms Arm I Patients receive oral Ro 31-7453 under fasting conditions on day 1 After a 1-week washout period patients receive oral Ro 31-7453 under fed conditions Arm II Patients receive fed treatment as in arm I on day 1 After a 1-week washout period patients receive fasted treatment as in arm I Both arms At the start of week 3 patients may continue to receive oral Ro 31-7453 every 12 hours on days 1-4 Treatment repeats every 3 weeks for at least 24 weeks in the absence of disease progression or unacceptable toxicity Patients are followed at 7 days
PROJECTED ACCRUAL A total of 10 patients 5 per arm will be accrued for this study
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 |
|---|---|---|---|
| NCI-G01-1928 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068537 | REGISTRY | None | None |
| ROCHE-NP15980C | None | None | None |