Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003980
Status:
SUSPENDED
Last Update Posted:
2012-07-11
First Post:
1999-11-01
Brief Title:
BIBX 1382 in Treating Patients With Solid Tumors
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase I and Pharmacokinetics Study to Determine the Safety of BIBX 1382 in Patients With a Solid Tumor on a Continuous Daily Oral Administration Schedule and After Single Oral and Intravenous Doses
Status:
SUSPENDED
Status Verified Date:
2012-07
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 BIBX 1382 in treating patients who have solid tumors
PURPOSE Phase I trial to study the effectiveness of BIBX 1382 in treating patients who have solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of oral BIBX 1382 in patients with solid tumors II Determine qualitative and quantitative toxicities of oral BIBX 1382 in these patients III Determine predictability duration intensity onset reversibility and dose relationship of the toxicities of oral BIBX 1382 in these patients IV Determine safe and optimal doses of oral BIBX 1382 for a Phase II study V Assess the pharmacokinetics of oral BIBX 1382 in these patients VI Document any antitumor activity in these patients treated with oral BIBX 1382
OUTLINE This is a dose escalation study Patients receive BIBX 1382 IV over 1 hour followed 7 days later by oral BIBX 1382 Beginning 3 days later patients receive oral BIBX 1382 daily for 28 days Courses of daily oral BIBX 1382 repeat every 28 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of oral BIBX 1382 The maximum tolerated dose MTD is defined as the dose at which dose limiting toxicity occurs in at least 2 of 6 patients Patients are followed for up to 4 weeks
PROJECTED ACCRUAL A total of 40-80 patients will be accrued for this study over 18 months
OUTLINE This is a dose escalation study Patients receive BIBX 1382 IV over 1 hour followed 7 days later by oral BIBX 1382 Beginning 3 days later patients receive oral BIBX 1382 daily for 28 days Courses of daily oral BIBX 1382 repeat every 28 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of oral BIBX 1382 The maximum tolerated dose MTD is defined as the dose at which dose limiting toxicity occurs in at least 2 of 6 patients Patients are followed for up to 4 weeks
PROJECTED ACCRUAL A total of 40-80 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 |
|---|---|---|---|
| EORTC-16981 | None | None | None |