on-Small Cell Lung Cancer (NSCLC) whose disease has progressed on therapy with Crizotinib

Phase 1

• Conditions: Patients with ALK-positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC); MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-002134-21-AT
• Lead Sponsor: ARIAD Pharmaceuticals, Inc. (a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-13
• Study Completion: 2016-02-29
• Last Update Posted: 30 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

All patients must meet all the following eligibility criteria for study entry:
1. Have histologically or cytologically confirmed locally advanced or
metastatic NSCLC that is ALK+.
2. Must meet one of the following two criteria:
a. Have documented ALK rearrangement by a positive result from the
Vysis® ALK Break-Apart fluorescence in situ hybridization (FISH)
Probe Kit; or
b. Have documented ALK positivity by a different test and tissue available for the Vysis® FISH test. Tissue should be derived preferably from abiopsy taken after progression with crizotinib. If such a sample is not available, testing may be performed with archived tumor tissue.
3. Had progressive disease while on crizotinib, as assessed by the investigator or treating physician.
4. No longer a required criterion as of Amendment 2
8. Are a male or female patient =18 years old.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 109
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 109

Exclusion Criteria

Patients meeting any of the criteria below are ineligible for the study:
1. Received any prior ALK-targeted TKI other than crizotinib.
2. Received crizotinib within 3 days of the first dose of AP26113 (Day 1, Cycle1).
3. Received cytotoxic chemotherapy, investigational agents, or radiation within 14 days, except SRS or stereotactic body radiosurgery.
4. Received monoclonal antibodies or had major surgery within 30 days of the first dose of AP26113 (Day 1, Cycle 1).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified