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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: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01685138 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 124 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
ORR per RECIST 1.1 calculated as the percentage of participants with a best overall response (OR) defined as complete response (CR) or partial response (PR) as assessed by the investigator. CR:Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Interventions
- DRUG LDK378
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2012-12-20 |
| Est. Completion | 2018-01-22 |
| Phase | Phase 2 |
What the finished NCT01685138 record still lists
NCT01685138 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which LDK378 is the first listed.
NCT01685138 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01685138's enrollment target sits among peer trials
124 564th of 2000 higher than 1,437 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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