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NCT01947023 · ClinicalTrials.gov registry record · Phase 1
Dabrafenib and Lapatinib in Treating Patients With Refractory Thyroid Cancer That Cannot Be Removed by Surgery
A Phase 1 study of Metastatic Thyroid Gland Carcinoma and Unresectable Thyroid Gland Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT01947023: Active Phase 1 study of Metastatic Thyroid Gland Carcinoma and Unresectable Thyroid Gland Carcinoma, sponsored by National Cancer Institute (NCI).
NCT01947023 is a Phase 1 study of Metastatic Thyroid Gland Carcinoma and Unresectable Thyroid Gland Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 21 participants, below the 35-participant average among 5 other Metastatic Thyroid Gland Carcinoma trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01947023, a Phase 1 study of Metastatic Thyroid Gland Carcinoma and Unresectable Thyroid Gland Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of lapatinib when given together with dabrafenib in treating patients with thyroid cancer that cannot be removed by surgery and has not responded to previous treatment (refractory). Dabrafenib selectively binds to and blocks the activity of v-raf murine sarcoma viral oncogene homolog B (BRAF), which may block the growth of tumor cells which contain a mutated BRAF gene. Lapatinib reversibly blocks the process in which a phosphate group is added to a molecule (phosphorylation) of the epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 2 (ErbB2), and the mitogen-activated protein kinase 3 (Erk-1) and mitogen-activated protein kinase 1(Erk-2) and protein kinase B (AKT) kinases. It also blocks cyclin D protein levels in human tumor cell lines. Dabrafenib and lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
Will be defined as the highest dose at which not more than 1/6 of the patients experience dose limiting toxicity MTD is defined as the highest dose at which not more than 1/6 of the patients experience dose limiting toxicity.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- DRUG Dabrafenib
- DRUG Dabrafenib Mesylate
Study Locations (1)
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2013-09-27 |
| Est. Completion | 2026-06-01 |
| Phase | Phase 1 |
What the registry record for NCT01947023 still lists
NCT01947023 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 35-participant average among 5 other Metastatic Thyroid Gland Carcinoma trials with a reported enrollment target (40% lower).
The record links to 2 conditions, with Metastatic Thyroid Gland Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT01947023 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01947023 about?
NCT01947023 is a clinical study titled "Dabrafenib and Lapatinib in Treating Patients With Refractory Thyroid Cancer That Cannot Be Removed by Surgery". This phase I trial studies the side effects and best dose of lapatinib when given together with dabrafenib in treating patients with thyroid cancer that cannot be removed by surgery and has not responded to previous treatment (refractory). Dabrafenib selectively binds to and blocks the activity of v...
What is the current status of trial NCT01947023?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2013-09-27. Estimated completion is 2026-06-01.
What conditions does trial NCT01947023 study?
This clinical trial studies the following conditions: Metastatic Thyroid Gland Carcinoma, Unresectable Thyroid Gland Carcinoma.
What interventions are being tested in trial NCT01947023?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Dabrafenib (DRUG), Dabrafenib Mesylate (DRUG).
Who is sponsoring clinical trial NCT01947023?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01947023 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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