Clinical trial · Interventional
Study of an Investigational Drug, ASP3026, in Patients With Advanced Malignancies (Solid Tumors and B-Cell Lymphoma)
A Phase 1, Multicenter, Open-Label, Dose Escalation Study of ASP3026 in Subjects With Advanced Malignancies
NCT01284192CI-TRIAL-00022752completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced malignancies (solid tumors and B-cell lymphoma).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignancies | — | UNRESOLVED | — |
| B-Cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Positive for Anaplastic Lymphoma Kinase | — | UNRESOLVED | — |
| Positive for Proto-Oncogene Tyrosine-Protein Kinase ROS | — | UNRESOLVED | — |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ASP3026 | Drug | ALK Inhibitor ASP3026 | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ASP3026
- description
- Subjects will receive escalated doses of ASP3026 to determine the maximum tolerated dose (MTD)
- interventionNames
- Drug: ASP3026
Primary outcomes (1)
- measure
- Safety and tolerability of ASP3026 assessed by recording of adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and clinical observations
- timeFrame
- Up to 30 days after last subject discontinues treatment
Secondary outcomes (2)
- measure
- Pharmacokinetic assessment through analysis of blood and urine samples
- timeFrame
- Up to Day 29
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Histologically or cytologically confirmed diagnosis of a relapsed/refractory solid tumor or B-cell lymphoma and meets at least 1 of the following criteria: * Disease progression despite standard therapies * No standard therapies are available or such therapies are not anticipated to result in a durable response * Standard therapies are considered unsuitable or have been refused * Able to take oral medications * Life expectancy \> 12 weeks * For the expansion cohort of the study, all subjects must be confirmed to be positive for ALK gene abnormalities * Subjects with stable brain metastasis will be allowed Exclusion Criteria: * Active central nervous system (CNS) metastases or leptomeningeal involvement as assessed through medical history review and physical examination (dose escalation subjects only) * Known history of a positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) * Known hereditary or acquired immunodeficiency syndrome or human immunodeficiency virus (HIV) infection * Cardiac arrhythmias \> Grade 1 using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.03 * Class 3 or 4 New York Heart Association congestive heart failure, acute coronary syndrome, myocardial infarction or cerebrovascular accident within 6 months prior to Cycle 1, Day 1 * Inadequate bone marrow, renal, and/or hepatic function * Confirmed active peptic ulcer disease or history of gastrointestinal bleeding within the past 3 months * Known history of long QT syndrome
References
Publications (1)
- DERIVEDLi T, LoRusso P, Maitland ML, Ou SH, Bahceci E, Ball HA, Park JW, Yuen G, Tolcher A. First-in-human, open-label dose-escalation and dose-expansion study of the safety, pharmacokinetics, and antitumor effects of an oral ALK inhibitor ASP3026 in patients with advanced solid tumors. J Hematol Oncol. 2016 Mar 10;9:23. doi: 10.1186/s13045-016-0254-5. PMID 26966027