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NCT01685060 · ClinicalTrials.gov registry record · Phase 2
LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
NCT01685060 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 140 participants.
The verdict
NCT01685060, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
Study Summary
A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anti-cancer therapy and/or died. LDK378 could be continued beyond RECIST-defined progressive disease (PD) as assessed by the investigator if, in the judgment of the investigator, there was evidence of clinical benefit. In these patients tumor assessment would continue as per the schedule of assessments until treatment with LDK378 was permanently discontinued. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator
Interventions
- DRUG LDK378
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2012-11-26 |
| Est. Completion | 2016-03-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01685060
The ClinicalTrials.gov registry entry for NCT01685060 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which LDK378 is the first listed.
NCT01685060 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01685060 about?
NCT01685060 is a clinical study titled "LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib". A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anti-cancer therapy and/or die...
What is the current status of trial NCT01685060?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2012-11-26. Estimated completion is 2016-03-29.
What interventions are being tested in trial NCT01685060?
The interventions under investigation include: LDK378 (DRUG).
Who is sponsoring clinical trial NCT01685060?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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