Ignite Creation Date:
2024-05-06 @ 3:17 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02259114
Status:
COMPLETED
Last Update Posted:
2021-01-26
First Post:
2014-10-03
Brief Title:
A Dose-Finding Study of Birabresib MK-8628 a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal BET Proteins in Adults With Selected Advanced Solid Tumors MK-8628-003
Sponsor:
Oncoethix GmbH a subsidiary of Merck Co Inc Rahway New Jersey USA
Organization:
Oncoethix GmbH a subsidiary of Merck Co Inc Rahway New Jersey USA
Study Overview
Official Title:
A Phase IB Trial With OTX015MK-8628 a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal BET Proteins in Patients With Selected Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2021-01
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:
Open-label phase I non-randomized multicentric study of single-agent birabresib MK-8628 formerly known as OTX015 administered according to two distinct regimens to participants with selected advanced tumors
The study will be performed in two parts
Dose Escalation Part
This step is designed to determine the maximum tolerated dose MTD in each of the two regimens which will be evaluated in parallel Participants will receive oral birabresib according to
Continuous Dosing Regimen continuous once daily for 21 consecutive days 21-day cycles
OR Days 1-7 Dosing Regimen once daily on Days 1 to 7 repeated every 3 weeks 21-day cycles 1 week ON2 weeks OFF
Participants will be sequentially assigned to Continuous Dosing Regimen or Days 1-7 Dosing Regimen according to the next available place and receive birabresib at escalating doses levels DL Cohorts of 3 participants will be treated and an additional 3 participants will be treated at the first indication of dose-limiting toxicity DLT MTD assessment will be based on the tolerability observed during the first 21 days of treatment
Expansion Part
The efficacy of birabresib in each of the five indications ie Bromodomain-Nuclear Protein in Testis BRD-NUT midline carcinoma triple negative breast cancer TNBC non-small cell lung cancer NSCLC harboring a rearrangement Anaplastic Lymphoma Kinase ALK genefusion protein or Kirsten Ras KRAS mutation castrate-resistant prostate cancer and pancreatic ductal carcinoma will be assessed in terms of response Response Evaluation Criteria in Solid Tumors v11 RECIST v11 or Prostate Cancer Clinical Trials Working Group 2 PCWG2 using a selected regimen
The study will be performed in two parts
Dose Escalation Part
This step is designed to determine the maximum tolerated dose MTD in each of the two regimens which will be evaluated in parallel Participants will receive oral birabresib according to
Continuous Dosing Regimen continuous once daily for 21 consecutive days 21-day cycles
OR Days 1-7 Dosing Regimen once daily on Days 1 to 7 repeated every 3 weeks 21-day cycles 1 week ON2 weeks OFF
Participants will be sequentially assigned to Continuous Dosing Regimen or Days 1-7 Dosing Regimen according to the next available place and receive birabresib at escalating doses levels DL Cohorts of 3 participants will be treated and an additional 3 participants will be treated at the first indication of dose-limiting toxicity DLT MTD assessment will be based on the tolerability observed during the first 21 days of treatment
Expansion Part
The efficacy of birabresib in each of the five indications ie Bromodomain-Nuclear Protein in Testis BRD-NUT midline carcinoma triple negative breast cancer TNBC non-small cell lung cancer NSCLC harboring a rearrangement Anaplastic Lymphoma Kinase ALK genefusion protein or Kirsten Ras KRAS mutation castrate-resistant prostate cancer and pancreatic ductal carcinoma will be assessed in terms of response Response Evaluation Criteria in Solid Tumors v11 RECIST v11 or Prostate Cancer Clinical Trials Working Group 2 PCWG2 using a selected regimen
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MK-8628-003 | OTHER | Merck Protocol Number | None |
| OTX015_108 | OTHER | None | None |
| 2014-002680-15 | EUDRACT_NUMBER | None | None |