Ignite Creation Date:
2024-05-06 @ 1:42 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01877811
Status:
COMPLETED
Last Update Posted:
2019-04-25
First Post:
2013-05-06
Brief Title:
Study of RXDX-105 Potent RET Inhibitor in Patients With Advanced Lung Cancer and Other Solid Tumors
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-Label Phase 11b Single-Agent Study of RXDX-105 in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2019-04
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 first-in-human multicenter open-label study consisting of 2 phases Phase 1 is a dose escalation study of RXDX-105 formerly known as CEP-32496 in patients with advanced solid tumors aimed at defining the recommended Phase 2 dose RP2D and schedule for administration Phase 1b is a dose expansion in approximately 90 patients with advanced solid tumors with specific histologies andor molecular alterations of interest Patients in Phase 1b will be treated at the RP2D determined in Phase 1
Detailed Description:
The primary objective of Phase 1 is to determine the recommended Phase 2 dose RP2D of RXDX-105 The primary objective of Phase 1b is to further assess the safety profile and tolerability of RXDX-105 at the RP2D The secondary objective is to evaluate the antitumor activity of RXDX-105 at the RP2D as assessed by objective response rate ORR complete response CR or partial response PR using Response Evaluation Criteria in Solid Tumors version 11 RECIST v11 in patients with advanced solid tumors with RET or BRAF mutations or rearrangements
The RP2D has been determined and Phase 1 portion of the study is now closed to new patient enrollment
Phase 1 b is open and enrolling patients with solid tumors harboring a RET rearrangement or mutation or a BRAF rearrangement or mutation Additionally patients with Squamous NSCLC and lung adenocarcinomas with other alterations than RET or BRAF such as KRAS mutations etc will also be enrolled Approximately 90 patients will be enrolled in Phase 1b
Each phase of this study will consist of a 28-day screening period Patients will be treated in 28-day treatment cycles until documented radiographic progression unacceptable toxicity withdrawal of consent or protocol specified parameters to stop treatment Patients in Phase 1 and 1b will be followed for 6 months after the last dose of study treatment
The RP2D has been determined and Phase 1 portion of the study is now closed to new patient enrollment
Phase 1 b is open and enrolling patients with solid tumors harboring a RET rearrangement or mutation or a BRAF rearrangement or mutation Additionally patients with Squamous NSCLC and lung adenocarcinomas with other alterations than RET or BRAF such as KRAS mutations etc will also be enrolled Approximately 90 patients will be enrolled in Phase 1b
Each phase of this study will consist of a 28-day screening period Patients will be treated in 28-day treatment cycles until documented radiographic progression unacceptable toxicity withdrawal of consent or protocol specified parameters to stop treatment Patients in Phase 1 and 1b will be followed for 6 months after the last dose of study treatment
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