A Phase 1 interventional study of ASP3026 in Advanced Malignancies, Positive for Anaplastic Lymphoma Kinase and Positive for Proto-Oncogene Tyrosine-Protein Kinase ROS, sponsored by Astellas Pharma Inc. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-28.
Sponsored by Astellas Pharma Inc · Phase 1, Interventional, and Treatment
This study is to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced malignancies (solid tumors and B-cell lymphoma).
This study will be conducted using a traditional 3 + 3 dose escalation study design. Enrollment of at least 3 subjects is planned for each dosing cohort until the Maximum Tolerated Dose (MTD) is determined. Up to three additional subjects per cohort may be enrolled if each additional subject is known to be positive for Anaplastic Lymphoma Kinase (ALK) or Proto-Oncogene Tyrosine-Protein Kinase ROS (ROS) abnormalities. The decision to expand a cohort or dose escalate will be based on the occurrence of dose limiting toxicities (DLTs) in Cycle 1 that are considered by the Investigator to be related (possibly or probably) to ASP3026. Intra-subject dose escalation will be allowed at the discretion of the investigators. The Safety Data Review Committee may elect to enroll additional subjects in a cohort to further evaluate the dose level. Once the MTD is determined, approximately 20 additional subjects with Anaplastic Lymphoma Kinase (ALK) abnormalities will be enrolled at the Recommended Phase 2 Dose. Each cycle will include 28 days of continuous dosing with ASP3026. Treatment with ASP3026 may continue until one of the discontinuation criteria is met.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 46 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.
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Histologically or cytologically confirmed diagnosis of a relapsed/refractory solid tumor or B-cell lymphoma and meets at least 1 of the following criteria:
Exclusion Criteria:
Subjects will receive escalated doses of ASP3026 to determine the maximum tolerated dose (MTD)
Drug: ASP3026
Tablet
Safety and tolerability of ASP3026 assessed by recording of adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and clinical observations
Time frame: Up to 30 days after last subject discontinues treatment
Pharmacokinetic assessment through analysis of blood and urine samples
Time frame: Up to Day 29
Objective response rate (ORR)
Objective response rate is the proportion of subjects who experience complete response/remission (CR) or partial response/remission (PR)
Time frame: 30 Days after the last subject discontinues treatment
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Inc