Ignite Creation Date:
2024-05-06 @ 12:37 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01616199
Status:
TERMINATED
Last Update Posted:
2018-05-16
First Post:
2012-06-06
Brief Title:
Study of PX-866 and Vemurafenib in Patients With Advanced Melanoma
Sponsor:
Cascadian Therapeutics Inc
Organization:
Seagen Inc
Study Overview
Official Title:
Phase 12 Study of PI-3K Inhibition With PX-866 Combined With Vemurafenib BRAF Inhibitor in Patients With BRAF-mutant Cancer Including Advanced Melanoma
Status:
TERMINATED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the phase 1 portion of the study is to determine the maximally tolerated dose MTD or recommended dose RD and the safetytolerability of PX-866 in combination vemurafenib in patients with any advanced BRAF-mutant cancer
The purpose of the phase 2 portion of the study is to compare progression free survival PFS antitumor activity response rate disease control rate DCR and the safety and tolerability of PX-866 in combination with vemurafenib vs vemurafenib alone in patients with advanced BRAF-mutant melanoma at the doses recommended from Phase 1
The purpose of the phase 2 portion of the study is to compare progression free survival PFS antitumor activity response rate disease control rate DCR and the safety and tolerability of PX-866 in combination with vemurafenib vs vemurafenib alone in patients with advanced BRAF-mutant melanoma at the doses recommended from Phase 1
Detailed Description:
This is a Phase 1 2 open-label study of PX-866 given in combination with vemurafenib to patients with BRAF-mutant cancer including advanced melanoma
Phase 1 will use a 33 dose escalation design to evaluate up to three dose levels of PX-866 in combination with up to two dose levels of vemurafenib in order to identify the maximal tolerated doserecommended dose MTDRD of both PX-866 and vemurafenib to be used in Phase 2 Vemurafenib will be administered orally twice per day on days 1-28 of all cycles except cycle 1 where vemurafenib will be administered on days 9-28 to allow for PK assessments PX-866 will be administered once per day on days 1-28 of each cycle
Phase 2 will evaluate the antitumor activity and safety of PX-866 given to patients randomized 21 to receive combination with vemurafenib at the doses recommended from Phase 1 compared with vemurafenib alone administered at the approved dose orally BID All treatments will be administered on a 28-day cycle
Patients randomized to receive single-agent vemurafenib may cross-over to receive the combination treatment at the time of progression Patients will be evaluated for progression approximately every 8 weeks for the initial 24 weeks and every 12 weeks thereafter All patients with stable disease SD or better will receive repeat cycles until disease progression PD unacceptable toxicity or withdrawal of consent
Phase 1 will use a 33 dose escalation design to evaluate up to three dose levels of PX-866 in combination with up to two dose levels of vemurafenib in order to identify the maximal tolerated doserecommended dose MTDRD of both PX-866 and vemurafenib to be used in Phase 2 Vemurafenib will be administered orally twice per day on days 1-28 of all cycles except cycle 1 where vemurafenib will be administered on days 9-28 to allow for PK assessments PX-866 will be administered once per day on days 1-28 of each cycle
Phase 2 will evaluate the antitumor activity and safety of PX-866 given to patients randomized 21 to receive combination with vemurafenib at the doses recommended from Phase 1 compared with vemurafenib alone administered at the approved dose orally BID All treatments will be administered on a 28-day cycle
Patients randomized to receive single-agent vemurafenib may cross-over to receive the combination treatment at the time of progression Patients will be evaluated for progression approximately every 8 weeks for the initial 24 weeks and every 12 weeks thereafter All patients with stable disease SD or better will receive repeat cycles until disease progression PD unacceptable toxicity or withdrawal of consent
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