Ignite Creation Date:
2024-05-06 @ 12:51 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03864042
Status:
COMPLETED
Last Update Posted:
2023-06-08
First Post:
2019-02-01
Brief Title:
Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
An Open-label Phase 1 Study to Evaluate Drug-Drug Interactions of Agents Co-Administered With Encorafenib and Binimetinib in Patients With BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2024-05
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 an open-label 3-arm fixed-sequence study to evaluate the effect of single and multiple oral doses of encorafenib in combination with binimetinib on the single oral dose pharmacokinetics PK of cytochrome P450 CYP enzyme probe substrates using a probe cocktail on an organic anion-transporting polypeptidebreast cancer resistance protein OATPBCRP substrate using rosuvastatin and on a CYP2B6 substrate using bupropion The effect of multiple oral doses of the moderate cytochrome P450 CYP inhibitor modafinil on encorafenib in combination with binimetinib will also be assessed The study will have 2 treatment phases a drug-drug interaction DDI phase followed by a post-DDI phase
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 |
|---|---|---|---|
| C4221003 | OTHER | None | None |
| 2019-001036-66 | EUDRACT_NUMBER | Alias Study Number | None |