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NCT01838642 · ClinicalTrials.gov registry record · Phase 2
Ponatinib for Advanced Medullary Thyroid Cancer
A Phase 2 study, sponsored by National Institutes of Health Clinical Center (CC).
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT01838642 is a Phase 2 study that was terminated before completion, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 3 participants.
The verdict
NCT01838642, a Phase 2 study, was terminated before completion, sponsored by National Institutes of Health Clinical Center (CC).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
Background: * Medullary thyroid cancer (MTC) represents 5% of thyroid cancers and presents as a hereditary (25% of cases) or sporadic (75% of cases) neuroendocrine malignancy. * MTC arises from the parafollicular C-cells of the thyroid. * Germline mutations in the rearranged during transfection (RET) proto-oncogene occur in virtually all of hereditary MTC cases, and somatic RET mutations occur in 50% of sporadic cases. * Drugs targeting RET kinase such as vandetanib and cabozantinib have shown efficacy in the treatment of advanced or metastatic MTC, however, more effective RET inhibitors are needed for previously untreated patients as well as patients who have become refractory to other molecular targeted therapeutics (MTTs). * Ponatinib, a drug that is Food and Drug Administration (FDA) approved as a therapy for chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), is a potent inhibitor of RET kinase. Primary Objective: -To determine the objective overall response rate (complete response \[CR\] + partial response \[PR\] by Response Evaluation Criteria in Solid Tumors (RECIST) to ponatinib in the treatment of patients with advanced or metastatic MTC previously treated with cabozantinib and vandetanib who: 1) have tumors with RET mutations and 2) have tumors without RET mutations. Eligibility: * Patients must have histologically confirmed, unresectable, locally advanced or metastatic MTC, with measurable disease by RECIST criteria. * Patients must have disease amenable to biopsy and be willing to undergo biopsy for molecular analysis, and also have adequate archival material from their thyroidectomy or from a tumor biopsy obtained prior to beginning any systemic therapy. * Patients must have failed or been intolerant to prior treatment with both cabozantinib and vandetanib. * The last dose of prior systemic therapy must be more than 28 days prior to the first dose of ponatinib * Radiation therapy is per
Interventions
- DRUG Ponatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2013-03 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01838642
The ClinicalTrials.gov registry entry for NCT01838642 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ponatinib is the first listed.
NCT01838642 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01838642 about?
NCT01838642 is a clinical study titled "Ponatinib for Advanced Medullary Thyroid Cancer". Background: * Medullary thyroid cancer (MTC) represents 5% of thyroid cancers and presents as a hereditary (25% of cases) or sporadic (75% of cases) neuroendocrine malignancy. * MTC arises from the parafollicular C-cells of the thyroid. * Germline mutations in the rearranged during transfection (RE...
What is the current status of trial NCT01838642?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2013-03. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01838642?
The interventions under investigation include: Ponatinib (DRUG).
Who is sponsoring clinical trial NCT01838642?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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