A Randomized Phase 2 Study of AP26113 in Patients with ALK-positive, Non-small Cell Lung Cancer (NSCLC) Previously Treated with Crizotinib
- Conditions
- cancer10038666
- Registration Number
- NL-OMON47796
- Lead Sponsor
- ARIAD Pharmaceuticals, Inc. (a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 8
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. Received crizotinib as the last therapy, within 30 days of the first dose of
AP26113. This criterion may be met by
reintroduction of crizotinib after intervening therapy. If crizotinib was
reintroduced, documented progression on the
most recent regimen of crizotinib must have occurred.
8. Are a male or female patient >=18 years old.
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Confirmed Objective Response Rate (ORR), as assessed by the investigator, per<br /><br>RECIST v1.1</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Endpoints:<br /><br>1. Confirmed ORR, as assessed by a central independent review committee (IRC),<br /><br>per RECIST v1.1<br /><br>2. CNS response (ORR and PFS, per RECIST v1.1, in patients who have active<br /><br>brain metastases)<br /><br>3. Time to response<br /><br>4. Duration of response<br /><br>5. Time on treatment<br /><br>6. Disease control rate (the percentage of patients with best response of<br /><br>complete response [CR], PR, or SD), per RECIST v1.1<br /><br>7. Progression Free Survival (PFS)<br /><br>8. Overall Survival (OS)<br /><br>9. Safety and tolerability<br /><br>10. Steady-state plasma level of AP26113 for use in population PK modeling<br /><br>11. Patient-reported symptoms of lung cancer and HRQoL scores, assessed with<br /><br>the EORTC QLQ-C30 (v3.0)</p><br>