Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410553
Status:
COMPLETED
Last Update Posted:
2018-10-03
First Post:
2006-12-11
Brief Title:
Eribulin Mesylate and Gemcitabine Hydrochloride in Treating Patients With Metastatic Solid Tumors or Solid Tumors That Cannot be Removed by Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Halichondrin B Analog E7389 in Combination With Gemcitabine in Patients With Refractory or Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2018-10
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 eribulin mesylate and gemcitabine hydrochloride in treating patients with metastatic or unresectable solid tumors Drugs used in chemotherapy such as eribulin mesylate and gemcitabine hydrochloride work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the recommended phase II dose RPTD of E7389 eribulin mesylate when given in combination with gemcitabine gemcitabine hydrochloride in patients with advanced cancer
II Determine the safety tolerability and toxicity profile of E7389 and gemcitabine given in combination
III Assess the antitumor activity of E7389 in combination with gemcitabine in patients with measurable disease
IV Determine the pharmacokinetic profile of E7389 and gemcitabine to assess for any possible interactions between the two agents
OUTLINE This is a multicenter dose-escalation study Patients receive eribulin mesylate intravenously IV and gemcitabine hydrochloride IV over 30 minutes on days 1 8 and 15 OR on days 1 and 8
Courses repeat every 28 or 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of eribulin mesylate and gemcitabine hydrochloride until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity DLT NOTE If DLT is observed at the first dose level of the 28-day schedule subsequent patients are treated on days 1 and 8 of the 21-day schedule patients enrolled in the expansion cohort patients with ovarian or endometrial cancer or chemotherapy-naive or minimally pre-treated cancer receive treatment according to the 21-day schedule
After completion of study treatment patients are followed at 4 weeks and then every 3 months thereafter
I Determine the recommended phase II dose RPTD of E7389 eribulin mesylate when given in combination with gemcitabine gemcitabine hydrochloride in patients with advanced cancer
II Determine the safety tolerability and toxicity profile of E7389 and gemcitabine given in combination
III Assess the antitumor activity of E7389 in combination with gemcitabine in patients with measurable disease
IV Determine the pharmacokinetic profile of E7389 and gemcitabine to assess for any possible interactions between the two agents
OUTLINE This is a multicenter dose-escalation study Patients receive eribulin mesylate intravenously IV and gemcitabine hydrochloride IV over 30 minutes on days 1 8 and 15 OR on days 1 and 8
Courses repeat every 28 or 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of eribulin mesylate and gemcitabine hydrochloride until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity DLT NOTE If DLT is observed at the first dose level of the 28-day schedule subsequent patients are treated on days 1 and 8 of the 21-day schedule patients enrolled in the expansion cohort patients with ovarian or endometrial cancer or chemotherapy-naive or minimally pre-treated cancer receive treatment according to the 21-day schedule
After completion of study treatment patients are followed at 4 weeks and then every 3 months thereafter
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 |
|---|---|---|---|
| N01CM17107 | NIH | CTEP | httpsreporternihgovquickSearchN01CM17107 |
| NCI-2009-00172 | REGISTRY | None | None |
| CDR0000520315 | None | None | None |
| PMH-PHL-048 | None | None | None |
| PHL-048 | OTHER | None | None |
| 7444 | OTHER | None | None |
| N01CM00032 | NIH | None | None |