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NCT01868022 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
NCT01868022 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 65 participants.
The verdict
NCT01868022, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
Study 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 3+3 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).
Interventions
- DRUG carboplatin
- DRUG pemetrexed
- DRUG docetaxel
- DRUG paclitaxel
- DRUG GSK3052230
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2013-10-09 |
| Est. Completion | 2017-10-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01868022
The ClinicalTrials.gov registry entry for NCT01868022 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which carboplatin is the first listed.
NCT01868022 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01868022 about?
NCT01868022 is a clinical study titled "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". 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 ...
What is the current status of trial NCT01868022?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2013-10-09. Estimated completion is 2017-10-24.
What interventions are being tested in trial NCT01868022?
The interventions under investigation include: carboplatin (DRUG), pemetrexed (DRUG), docetaxel (DRUG), paclitaxel (DRUG), GSK3052230 (DRUG).
Who is sponsoring clinical trial NCT01868022?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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