Ignite Creation Date:
2024-05-06 @ 1:53 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01928940
Status:
COMPLETED
Last Update Posted:
2017-07-24
First Post:
2013-07-03
Brief Title:
Japan PhIII of GSK2118436 and GSK1120212 Combination in Subjects With BRAF V600EK Mutation Positive Advanced Solid Tumors Phase I Part or Cutaneous Melanoma Phase II Part
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Japanese Open-label Phase III Study to Assess the Safety Tolerability Pharmacokinetics and Efficacy of GSK2118436 and GSK1120212 Combination Therapy in Subjects With BRAF V600EK Mutation Positive Advanced Solid Tumors Phase I Part and BRAF V600EK Mutation Positive Cutaneous Melanoma Phase II Part
Status:
COMPLETED
Status Verified Date:
2017-07
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 Japanese Phase III open-label non-controlled study to evaluate the safety tolerability pharmacokinetic profile and efficacy of the combination of GSK2118436 and GSK1120212 in subjects with BRAF V600EK mutation positive advanced solid tumors Phase I part and BRAF V600EK mutation positive cutaneous melanoma Phase II part
Detailed Description:
This is a Japanese Phase III open-label non-controlled study to evaluate the safety tolerability pharmacokinetic profile and efficacy of the combination of GSK2118436 and GSK1120212 in subjects with BRAF V600EK mutation positive advanced solid tumors Phase I part and BRAF V600EK mutation positive cutaneous melanoma Phase II part Phase I part is designed to primarily assess the safety and tolerability of GSK2118436 and GSK1120212 combination therapy in subjects with BRAF V600EK mutation positive advanced solid tumors Six evaluable subjects will be enrolled into Phase I part and receive the combination therapy of GSK2118436 150 mg twice daily and GSK1120212 2 mg once daily A decision for starting Phase II part will be made by careful review based on available safety tolerability and pharmacokinetic data in Phase I part Phase II part is designed to primarily evaluate ORR of the combination as first-line therapy in subjects with unresectable Stage IIIC or metastatic Stage IV BRAF V600EK mutation positive cutaneous melanoma Subjects who have had prior systemic anti-cancer treatment in the advanced or metastatic setting will not be eligible for Phase II part although prior systemic treatment in the adjuvant setting will be allowed Six evaluable subjects will be enrolled in Phase II part
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