Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003403
Status:
COMPLETED
Last Update Posted:
2013-04-23
First Post:
1999-11-01
Brief Title:
GPX-100 in Treating Patients With Solid Tumors
Sponsor:
Gem Pharmaceuticals
Organization:
Gem Pharmaceuticals
Study Overview
Official Title:
Phase I Safety and Efficacy Study of an Intravenous Formulation of the Anthracycline Analog GPX-100 in the Treatment of Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2001-02
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 GPX-100 in treating patients who have solid tumors
PURPOSE Phase I trial to study the effectiveness of GPX-100 in treating patients who have solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of GPX-100 in outpatients with incurable solid tumors who are not candidates for effective systemic therapy II Evaluate and quantify the toxicity of GPX-100 in this patient population III Identify any changes in disease status in this patient population
OUTLINE This is an open label multicenter dose escalation study Patients receive GPX-100 IV once every 3 weeks Patients receive 2 courses of treatment in the absence of disease progression or dose limiting toxicity Treatment may continue for up to 6 courses 4 courses with prior doxorubicin in patients with responding or non-progressing disease One patient is entered at each of the first 3 dose levels Cohorts of 3-6 patients are entered at subsequent dose levels The maximum tolerated dose of GPX-100 is defined as the dose at which no more than 2 instances of dose limiting toxicity are observed in 6 patients
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study
OUTLINE This is an open label multicenter dose escalation study Patients receive GPX-100 IV once every 3 weeks Patients receive 2 courses of treatment in the absence of disease progression or dose limiting toxicity Treatment may continue for up to 6 courses 4 courses with prior doxorubicin in patients with responding or non-progressing disease One patient is entered at each of the first 3 dose levels Cohorts of 3-6 patients are entered at subsequent dose levels The maximum tolerated dose of GPX-100 is defined as the dose at which no more than 2 instances of dose limiting toxicity are observed in 6 patients
PROJECTED ACCRUAL A maximum of 30 patients 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-V98-1441 | None | None | None |
| GEM-97-002 | None | None | None |
| MAYO-IRB-153-98 | None | None | None |