Study of an Investigational Drug, ASP3026, in Patients With Advanced Malignancies (Solid Tumors and B-Cell Lymphoma)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced malignancies (solid tumors and B-cell lymphoma).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Dose Escalation and Expansion Study of ASP4132 to Subjects With Advanced Refractory Tumors and Lymphoma

NCT02383368

Lymphoma Refractory Solid Tumors Advanced Cancer

COMPLETED PHASE1

Study of an Investigational Drug, ASP3026, in Patients With Solid Tumors

NCT01401504

Solid Tumor

COMPLETED PHASE1

A Study of ASP3082 in Adults With Advanced Solid Tumors

NCT05382559

Solid Tumor

RECRUITING PHASE1

A Phase I Study of Safety, Tolerability, and PK of AZD2811 in Patients With Advanced Solid Tumors.

NCT02579226

Advanced Solid Tumours

COMPLETED PHASE1

A Dose-escalation Study in Subjects With Advanced Malignancies

NCT01072266

Solid Tumor Advanced Cancer Metastatic Cancer

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Malignancies Positive for Anaplastic Lymphoma Kinase Positive for Proto-Oncogene Tyrosine-Protein Kinase ROS Solid Tumor B-Cell Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ASP3026

Subjects will receive escalated doses of ASP3026 to determine the maximum tolerated dose (MTD)

Group Type EXPERIMENTAL

ASP3026

Intervention Type DRUG

Tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ASP3026

Tablet

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No