Ignite Creation Date:
2024-05-06 @ 1:40 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01868022
Status:
COMPLETED
Last Update Posted:
2019-08-19
First Post:
2013-05-30
Brief Title:
Study to Evaluate GSK3052230 in Combination With Paclitaxel and Carboplatin or Docetaxel or as Single Agent in Subjects With Solid Malignancies and Deregulated Fibroblast Growth Factor FGF Pathway Signaling
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Multi-arm Non-randomized Open-Label Phase IB Study to Evaluate GSK3052230 in Combination With Paclitaxel and Carboplatin or Docetaxel or as Single Agent in Subjects With Solid Malignancies and Deregulated FGF Pathway Signaling
Status:
COMPLETED
Status Verified Date:
2019-08
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 phase IB trial aims to identify anticancer activity of GSK3052230 in subjects with malignancies with abnormal dependence on FGF pathway signaling Combination doses of GSK3052230 with standard of care chemotherapy in the first and second line or greater setting of metastatic squamous non-small cell lung cancer NSCLC and first line malignant pleural mesothelioma subjects will be studied in the 33 dose-escalation design This will be a multi-arm multicenter non-randomized parallel-group uncontrolled open-label Phase IB study designed to evaluate the safety tolerability and preliminary activity of GSK3052230 in combination with paclitaxel carboplatin Arm A in combination with docetaxel Arm B or in combination with pemetrexed cisplatin Arm C Approximately 70 subjects will be enrolled in the study approximately up to 120 may be enrolled
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 |
|---|---|---|---|
| 2013-000354-21 | EUDRACT_NUMBER | None | None |