Viewing Study NCT00001504



Ignite Creation Date: 2024-05-05 @ 10:23 AM
Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00001504
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 1999-11-03

Brief Title: A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients
Sponsor: National Cancer Institute NCI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients
Status: COMPLETED
Status Verified Date: 2002-01
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 is a dosage escalation study to estimate the maximum tolerated dose of 9-cis-retinoic acid given in combination with tamoxifen Groups of 3 to 6 patients receive oral 9-cis-retinoic acid daily for 4 weeks after which daily oral tamoxifen is added to the regimen Patients continue treatment for up to 28 weeks with tamoxifen continued after the study if medically appropriate
Detailed Description: This is a Phase I study of the combination tamoxifen and 9-cis-Retinoic acid in patients with breast cancer The primary objective of the study is 1 to determine the maximum tolerated dose of 9-cis-Retinoic acid in combination with Tamoxifen and to determine the overall and dose limiting toxicities Other objectives are 2 to determine the effect of Tamoxifen on the pharmacokinetics of 9-cis-Retinoic acid 3 to evaluate the anti-tumor activity of this combination therapy within the context of a phase I study 4 and to determine the expression of surrogate biomarkers of breast carcinogenesis before and after treatment

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
96-C-0080 None None None