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

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-23

Study Completion Date

2018-04-27

Brief Summary

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

The purpose of this study is to evaluate the safety and tolerability of ASP4132 and to determine the maximum tolerated dose and recommended phase 2 dose of ASP4132. The study will also determine the pharmacokinetics (PK) of ASP4132 and evaluate the preliminary antitumor activity.

Related Clinical Trials

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

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

NCT01284192

Advanced Malignancies Positive for Anaplastic Lymphoma Kinase Positive for Proto-Oncogene Tyrosine-Protein Kinase ROS +2 more

COMPLETED PHASE1

A Study of ASP3082 in Adults With Advanced Solid Tumors

NCT05382559

Solid Tumor

RECRUITING PHASE1

Study of AS1411 in Advanced Solid Tumours

NCT00881244

Advanced Solid Tumors

COMPLETED PHASE1

Study to Assess Safety, Tolerability and PK of AZD1480 in Patients With Solid Tumours

NCT01112397

Solid Malignancies

TERMINATED PHASE1

A Study of ASP1002 in Adults for Treatment of Solid Tumors

NCT05719558

Advanced Solid Tumors

RECRUITING PHASE1

Detailed Description

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

The study consists of two parts and these will be conducted sequentially: Part 1 (dose escalation) and Part 2 (dose expansion). Subjects will participate in Part 1 or Part 2.

Conditions

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

Lymphoma Refractory Solid Tumors Advanced Cancer

Study Design

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

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

ASP4132 dose escalation

Subjects will receive a single dose of the study drug on Day -4 (Single-Dose Period), followed by PK sampling prior to Multiple-Dose Period where they will receive the same dose as they received in the Single-Dose Period on one of four schedules:

Continuous - daily dosing for 28 days, Intermittent: Schedule A: 3 days on / 4 days off; Schedule B: 1 days on / 6 days off; Schedule C: 3 days on / 11 days off.

Group Type EXPERIMENTAL

ASP4132

Intervention Type DRUG

oral

ASP4132 dose expansion

Subjects in Part 2 will be treated with ASP4132 at the MTD and dosing schedule identified from Part 1.

Group Type EXPERIMENTAL

ASP4132

Intervention Type DRUG

oral

Interventions

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

ASP4132

oral

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Subject has a life expectancy of more than 3 months
* Subject agrees not to participate in another interventional study while on treatment.
* Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* Female subject must be either:

1. Of non-child bearing potential:

* post-menopausal (defined as at least 1 year without any menses) prior to Screening,
* or, documented surgically sterile or status post hysterectomy
2. Or, if of childbearing potential,

* agree not to try to become pregnant during the study and for 90 days after the final study drug administration;
* if heterosexually active must use two forms of birth control
* Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 90 days after the final study drug administration.
* Subject must have advanced and/or metastatic, histologically or cytologically documented cancer or lymphomas, for whom there is no available standard therapy shown to provide clinical benefit.

Exclusion Criteria

* Subject has absolute neutrophil count \< 1000/μL, platelet count \< 75,000/μL, and hemoglobin \< 8 g/dL (\< 5 mmol/L) at Screening
* Subject has total serum bilirubin ≥1.5 times the upper limit of normal (ULN),serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) \> 3 times ULN, or albumin ≤ 3.0 g/dL at Screening.
* Subject has any abnormalities in serum sodium, potassium, chloride, calcium and magnesium levels ≥ Grade 2 at screening (CTCAE Version 4.03).
* Subject has a known elevation in serum lactate at screening ˃ 2x institutional ULN
* Subject has an estimated glomerular filtration rate (eGFr) of \< 60ml/min as calculated by the modification of diet Renal disease (MDRD) Equation.
* Subject with a QTcF of \> 450 msec in male subjects and \> 470 msec in female subjects on the screening 12 lead ECG.
* Subject has Neuropathy ≥ Grade 2 at Screening.
* Subject has Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus and currently being treated with insulin or sulfonylureas.
* Subject has concomitant active second malignancies unless remission was achieved at least 3 years prior to study entry and subject is no longer on therapy for the malignancy.
* Subject has a significant cardiovascular disease
* Subject has a known history of acute or chronic hepatitis B (HBV), HIV or hepatitis C (HCV) infection.
* Subject has serious/active bacterial, viral or fungal infection requiring systemic treatment.
* Subject has significant gastrointestinal abnormalities, including ulcerative colitis, chronic diarrhea associated with intestinal malabsorption, Crohn's disease, and/or prior surgical procedures affecting absorption or requirement for intravenous (IV) alimentation.
* Subject has active central nervous system (CNS) metastases not controlled by prior surgery or radiotherapy (subjects must be off steroids). Subjects with signs or symptoms suggestive of brain metastasis are not eligible unless brain metastases are ruled out by brain MRI/CT.
* Subject has concurrent severe or uncontrolled medical disease or organ system dysfunction which, in the opinion of the Investigators, would limit life expectancy to \< 3 months.
* Subject has psychiatric disorder or altered mental status that would preclude an understanding of the informed consent process and/or completion of the necessary study procedures.
* Subject has difficulty swallowing large pills.
* Subject currently being treated with biguanides or other agents known to increase risk of lactic acidosis.
* Subject has unavoidable concomitant treatment with any drug known for causing Torsades de Pointes.
* Subject has had radiotherapy or surgery within the 4 weeks prior to treatment with ASP4132.
* Subject has not discontinued all previous systemic therapies for cancer including chemotherapy, immunotherapy, or biological therapies for at least 14 days prior to the initiation of ASP4132.
* Subject has not fully recovered from the acute toxicities (except alopecia) of any prior anti-cancer therapy.
* Subject requiring concomitant use of strong CYP3A4 inhibitors or inducers.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No