Phase I Study of AT13148, a Novel AGC Kinase Inhibitor
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|ClinicalTrials.gov Identifier: NCT01585701|
Recruitment Status : Recruiting
First Posted : April 26, 2012
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumours||Biological: AT13148||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Cancer Research UK Phase I First in Man Study of the Novel AGC Kinase Inhibitor AT13148 Given Orally in Patients With Advanced Solid Tumours.|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||May 2017|
- Determining a dose at which no more than one patient out of up to six patients at the same dose level experience a highly probably or probably drug-related dose limiting toxicity (DLT).
- Determining causality of each adverse event Adverse Event to AT13148 and grading severity according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02.
- Determining the correlation between pharmacokinetic studies and toxicity and/or efficacy.
- Any response (stable disease, partial response or complete response) in any of the patients as determined by the Response Evaluation Criteria in Solid Tumours RECIST) criteria version 1.1.criteria version 1.1.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01585701
|Royal Marsden Hospital, Institute of Cancer Research||Recruiting|
|Sutton, Surrey, United Kingdom, SM2 5PT|
|Contact: Udai Banerji, Dr udai.Banerji@icr.ac.uk|
|Principal Investigator: Udai Banerji, Dr|