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NCT01685138 · ClinicalTrials.gov registry record · Phase 2
LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 124
- Enrollment target
NCT01685138 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 124 participants.
The verdict
NCT01685138, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 124 participants
- Enrollment target
Study Summary
A single-arm, open-label, two-stage multicenter, phase II study. Patients were pre-screened for ALK positive status. Treatment with LDK378 at 750 mg qd was continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anticancer therapy and/or died. LDK378 was 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. 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. Male and female patients aged 18 or over with ALK-rearranged non-small cell cancer (NSCLC) were screened for eligibility. Patients had to have received no prior crizotinib, and had to be chemotherapy-naïve or been pretreated with cytotoxic chemotherapy (up to three prior lines).
Interventions
- DRUG LDK378
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2012-12-20 |
| Est. Completion | 2018-01-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01685138
The ClinicalTrials.gov registry entry for NCT01685138 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 124 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.
NCT01685138 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01685138 about?
NCT01685138 is a clinical study titled "LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer". A single-arm, open-label, two-stage multicenter, phase II study. Patients were pre-screened for ALK positive status. Treatment with LDK378 at 750 mg qd was continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the ...
What is the current status of trial NCT01685138?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2012-12-20. Estimated completion is 2018-01-22.
What interventions are being tested in trial NCT01685138?
The interventions under investigation include: LDK378 (DRUG).
Who is sponsoring clinical trial NCT01685138?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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