Ignite Creation Date:
2024-05-06 @ 12:19 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01543698
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2012-02-01
Brief Title:
A Phase IbII Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF Dependent Advanced Solid Tumors
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Phase IbII Multicenter Open-label Dose Escalation Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF V600 - Dependent Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2024-02
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 multi-center open-label dose finding Phase Ib dose escalation study to estimate the MTDs andor RP2Ds for the dual combination of LGX818 and MEK162 and the triple combination of LGX818 and MEK162 and LEE011 followed each independently by a Phase II part to assess the clinical efficacy and to further assess the safety of the combinations in selected patient populations Oral LGX818 and MEK162 will be administered on a continuous schedule Oral LEE011 will be administered once daily on a three weeks on one week off schedule Patients will be treated until progression of disease unacceptable toxicity develops or withdrawal of informed consent whichever occurs first A cycle is defined as 28 days The dose escalation parts of the trial will be conducted in adult patients with BRAF V600-dependent advanced solid tumors and is expected to enroll at least 18 patients for the dual combination and at least 12 patients for the triple combination The dose escalation will be guided by a Bayesian logistic regression model BLRM Following MTDRP2D declaration patients will be enrolled in three Phase II arms for the dual combination and one Phase II arm for the triple combination All patients will be followed for 30 days for safety assessments after study drugs discontinuation All patients enrolled in the Phase II part of the study will be followed for survival
Detailed Description:
None
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 |
|---|---|---|---|
| 2011-005875-17 | EUDRACT_NUMBER | Alias Study Number | None |
| C4221005 | OTHER | None | None |