Ignite Creation Date:
2024-05-06 @ 7:55 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02624700
Status:
TERMINATED
Last Update Posted:
2020-07-14
First Post:
2015-12-03
Brief Title:
2nd Line Treatment With Pemetrexed and Sorafenib for Recurrent or Metastatic Triple Negative Breast Cancer
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Phase 2 Study of Pemetrexed and Sorafenib for Treatment of Recurrent or Metastatic Triple Negative Breast Cancer
Status:
TERMINATED
Status Verified Date:
2020-06
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 2 clinical trial will evaluate the efficacy of the combination of pemetrexed and sorafenib in patients with recurrent or metastatic Triple Negative Breast Cancer TNBC Candidate pharmacodynamic and predictive biomarkers will also be evaluated
Detailed Description:
This study is a single-arm open-label phase 2 study of a regimen of dose-dense pemetrexed and sorafenib to determine the objective response rate in patients with recurrent or metastatic TNBC Eligible patients will be those who have had disease progression during or after treatment for recurrent or metastatic disease with one previous cytotoxic chemotherapy regimen Additionally patients with disease progression or recurrence during or within 6 months of completion of adjuvant or neoadjuvant therapy are also eligible Correlative studies will be conducted using blood samples and archived tumor samples
Simons two-stage design will be utilized in this study In the first stage if there are 3 patients of the first 18 efficacy-evaluable patients who have a partial or complete response then the trial will end for futility If 4 patients have a partial or complete response patient accrual will continue in the second stage to add 10 more efficacy-evaluable patients
The total sample size for the Simons two-stage design is 35 patients Based on enrollment of 2-3 patients per month the expected enrollment period will be about 12-18 months
Patients were enrolled in 2 sequential groups referred to as arms for the purposes of reporting results by group The initial group of patients were enrolled in what is referred to here as Arm A After a study amendment patients were enrolled in what is referred to here as Arm B
Simons two-stage design will be utilized in this study In the first stage if there are 3 patients of the first 18 efficacy-evaluable patients who have a partial or complete response then the trial will end for futility If 4 patients have a partial or complete response patient accrual will continue in the second stage to add 10 more efficacy-evaluable patients
The total sample size for the Simons two-stage design is 35 patients Based on enrollment of 2-3 patients per month the expected enrollment period will be about 12-18 months
Patients were enrolled in 2 sequential groups referred to as arms for the purposes of reporting results by group The initial group of patients were enrolled in what is referred to here as Arm A After a study amendment patients were enrolled in what is referred to here as Arm B
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2015-02190 | REGISTRY | NCI CTRP | None |
| HM20005967 | None | None | None |