Clinical trial · Interventional
Study of an Investigational Drug, ASP3026, in Patients With Solid Tumors
A Phase I, Non-randomized, Open-label, Repeat Oral Administration Study of ASP3026 in Patients With Solid Tumors
NCT01401504CI-TRIAL-00014829completedPhase 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)
A study to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced malignancies (solid tumors).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 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
- 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
- Pharmacokinetics of ASP3026 by assessment of area under the curve over the time (AUC) and maximum concentration (Cmax) in plasma and urine
- timeFrame
- Up to Day 29
- measure
- Objective response rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 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 * Patient 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 * Life expectancy \> 12 weeks * Able to be hospitalized from 1 day prior to the initial dosing until day 15 of the dosing, and from day 27 until day 29 of the dosing Exclusion Criteria: * Patient exhibits persistent subjective and objective findings of toxicity ≥ Grade 2 (CTCAE v4.0-JCOG) from the previous cancer treatment with antitumor effect (except of alopecias) * Received previous treatment with antitumor effect within 21 days prior to the scheduled initial dosing * Patient had a major surgical procedure within 21 days prior to the scheduled initial dosing or a major surgical procedure scheduled during the course of the study * Use of an investigational drug or device within 21 days prior to the scheduled initial dosing * Use of blood transfusion or hematopoietic growth factors within 14 days prior to the scheduled initial dosing * A positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) * Known history of a positive test for human immunodeficiency virus (HIV) infection * Patient has central nervous system (CNS) or leptomeningeal involvement with clinical symptoms
References
Publications (2)
- DERIVEDOno A, Murakami H, Seto T, Shimizu T, Watanabe S, Takeshita S, Takeda K, Toyoshima J, Nagase I, Bahceci E, Morishita M, Morita S, Fukuoka M, Nakagawa K. Safety and Antitumor Activity of Repeated ASP3026 Administration in Japanese Patients with Solid Tumors: A Phase I Study. Drugs R D. 2021 Mar;21(1):65-78. doi: 10.1007/s40268-020-00331-2. Epub 2020 Dec 17. PMID 33331996
- DERIVEDOno A, Murakami H, Serizawa M, Wakuda K, Kenmotsu H, Naito T, Taira T, Koh Y, Ohde Y, Nakajima T, Endo M, Takahashi T. Drastic initial response and subsequent response to two ALK inhibitors in a patient with a highly aggressive ALK-rearranged inflammatory myofibroblastic tumor arising in the pleural cavity. Lung Cancer. 2016 Sep;99:151-4. doi: 10.1016/j.lungcan.2016.07.002. Epub 2016 Jul 5. PMID 27565932