Study of an Investigational Drug, ASP3026, in Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT01401504|
Recruitment Status : Completed
First Posted : July 25, 2011
Last Update Posted : June 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: ASP3026||Phase 1|
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. 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. The Safety Data Review Committee may elect to enroll additional subjects in a cohort to further evaluate the dose level. Each cycle will include 28 days of continuous dosing with ASP3026. Treatment with ASP3026 may continue until one of the discontinuation criteria is met.
The maximum tolerated dose (MTD) is defined as the highest dose of ASP3026 on a dosing schedule at which < 33% of subjects experience a DLT during Cycle 1. The MTD or lower dose, as determined by the Safety Data Review Committee, will be the recommended Phase 2 dose (RP2D). Twelve additional patients will be treated at the RP2D to further evaluate safety and tolerability.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Non-randomized, Open-label, Repeat Oral Administration Study of ASP3026 in Patients With Solid Tumors|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
- 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 ]
- Pharmacokinetics of ASP3026 by assessment of area under the curve over the time (AUC) and maximum concentration (Cmax) in plasma and urine [ Time Frame: Up to Day 29 ]
- Objective response rate (ORR) [ Time Frame: 30 Days after the last subject discontinues treatment ]Objective response rate is the proportion of subjects who experience complete response/remission (CR) or partial response/remission (PR)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401504
|Study Chair:||Use Central Contact||Astellas Pharma Inc|