Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04488003
Status:
TERMINATED
Last Update Posted:
2024-06-04
First Post:
2020-07-17
Brief Title:
Study of Ulixertinib for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations
Sponsor:
BioMed Valley Discoveries Inc
Organization:
BioMed Valley Discoveries Inc
Study Overview
Official Title:
A Two-Part Phase II Multi-center Study of the ERK Inhibitor Ulixertinib BVD-523 for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment challenges
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT04566393
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
None
Brief Summary:
This BVD-523-ABC study builds on the safety and clinical activity experience of previous studies that have evaluated ulixertinib as a novel targeted cancer treatment in cohorts of patients with specific genetic alterations and tumor histologies that result in aberrant MAPK pathway signaling Early clinical data have demonstrated anti-tumor activity with ulixertinib treatment and have identified specific groups of patients for whom additional development is warranted
Detailed Description:
This multi-center phase II study will be conducted in two parts and assess the clinical benefit safety pharmacokinetics and pharmacodynamics of ulixertinib BVD-523 in patients with advanced malignancies
Part A tumor histology agnostic will be open label and enroll patients to one of six groups based on their tumor alteration Targeted enrollment per group was 38 patients with a total targeted enrollment of 228 patients Actual enrollment was total of 104 patients with 77 patients allocated to treatment
Group 1 Patients with tumors other than colorectal cancer CRC having a BRAF alteration that results in an amino acid change at positions G469 L485 or L597
Group 2 Patients with tumors other than CRC having a defined Class 2 BRAF alteration see Appendix 2 of protocol
Group 3 Patients with tumors other than CRC having an atypical BRAF alteration non V600 that is not specified in Group 1 or Group 2
Group 4 Patients with CRC having any atypical BRAF alteration
Group 5 Patients with tumors other than CRC harboring alterations in MEK12
Group 6 Patients with CRC harboring alterations in MEK12
Part B tumor histology specific will randomly enroll patients with one of up to three specified tumor histologies to receive either ulixertinib or the physicians choice of treatment in a 21 ratio Tumors must harbor a specified MEK or atypical BRAF alteration If a patient progresses on physicians choice of treatment crossover to the ulixertinib arm is permittedThe specific histologies to be included in this part will be selected based on available data and discussion with the clinical investigators the medical monitor and the sponsor Total enrollment was targeted to approximately 80-100 patients per histology with up to three histologies included however the study was terminated prior to any patients enrolling in Part B
Part A tumor histology agnostic will be open label and enroll patients to one of six groups based on their tumor alteration Targeted enrollment per group was 38 patients with a total targeted enrollment of 228 patients Actual enrollment was total of 104 patients with 77 patients allocated to treatment
Group 1 Patients with tumors other than colorectal cancer CRC having a BRAF alteration that results in an amino acid change at positions G469 L485 or L597
Group 2 Patients with tumors other than CRC having a defined Class 2 BRAF alteration see Appendix 2 of protocol
Group 3 Patients with tumors other than CRC having an atypical BRAF alteration non V600 that is not specified in Group 1 or Group 2
Group 4 Patients with CRC having any atypical BRAF alteration
Group 5 Patients with tumors other than CRC harboring alterations in MEK12
Group 6 Patients with CRC harboring alterations in MEK12
Part B tumor histology specific will randomly enroll patients with one of up to three specified tumor histologies to receive either ulixertinib or the physicians choice of treatment in a 21 ratio Tumors must harbor a specified MEK or atypical BRAF alteration If a patient progresses on physicians choice of treatment crossover to the ulixertinib arm is permittedThe specific histologies to be included in this part will be selected based on available data and discussion with the clinical investigators the medical monitor and the sponsor Total enrollment was targeted to approximately 80-100 patients per histology with up to three histologies included however the study was terminated prior to any patients enrolling in Part 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?:
None
Is an FDA AA801 Violation?:
None