Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101972
Status:
COMPLETED
Last Update Posted:
2022-02-22
First Post:
2005-01-18
Brief Title:
RAV12 in Treating Patients With Metastatic or Recurrent Adenocarcinoma
Sponsor:
MacroGenics
Organization:
MacroGenics
Study Overview
Official Title:
A Phase I Multi-Dose Study of RAV12 ANTI-RAAG12 MAB in Patients With Metastatic or Recurrent Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2022-02
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 Monoclonal antibodies such as RAV12 can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them
PURPOSE This phase I trial is studying the side effects and best dose of RAV12 in treating patients with metastatic or recurrent adenocarcinoma
PURPOSE This phase I trial is studying the side effects and best dose of RAV12 in treating patients with metastatic or recurrent adenocarcinoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of RAV12 in patients with metastatic or recurrent adenocarcinoma
Determine the toxicity profile of this drug in these patients
Determine the pharmacokinetics and immunogenicity of this drug in these patients
Determine preliminarily the antitumor activity of this drug in these patients
OUTLINE This is an open-label dose-escalation study
Patients receive RAV12 IV over 2 hours 2-3 times per week in weeks 1-4 course 1 Patients are evaluated for response on day 43 Patients achieving a partial or complete response may be eligible to receive additional courses of RAV12 as above Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of RAV12 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Up to 15 additional patients are treated at the MTD in 1 or more patients groups eg colorectal pancreatic gastroesophageal and other adenocarcinoma
After completion of study treatment patients are followed within 4 weeks and then every 6-12 months thereafter
PROJECTED ACCRUAL A total of 75 patients will be accrued for this study
Determine the maximum tolerated dose of RAV12 in patients with metastatic or recurrent adenocarcinoma
Determine the toxicity profile of this drug in these patients
Determine the pharmacokinetics and immunogenicity of this drug in these patients
Determine preliminarily the antitumor activity of this drug in these patients
OUTLINE This is an open-label dose-escalation study
Patients receive RAV12 IV over 2 hours 2-3 times per week in weeks 1-4 course 1 Patients are evaluated for response on day 43 Patients achieving a partial or complete response may be eligible to receive additional courses of RAV12 as above Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of RAV12 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Up to 15 additional patients are treated at the MTD in 1 or more patients groups eg colorectal pancreatic gastroesophageal and other adenocarcinoma
After completion of study treatment patients are followed within 4 weeks and then every 6-12 months thereafter
PROJECTED ACCRUAL A total of 75 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 |
|---|---|---|---|
| RAVENBIO-RV-2004-002 | OTHER | Raven biotechnologies MacroGenics | None |