Dose-escalation, Safety and Pharmacokinetic Study of Briciclib in Advanced Solid Tumors
|ClinicalTrials.gov Identifier: NCT02168725|
Recruitment Status : Suspended
First Posted : June 20, 2014
Last Update Posted : May 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms Advanced Solid Tumor||Drug: briciclib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Dose-escalation Study of the Safety, Pharmacokinetics and Efficacy of Weekly Intravenous Briciclib in Patients With Advanced Solid Tumors|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||December 2018|
The starting dose of briciclib in the Escalation Stage will be 17 mg/week, with subsequent dose escalation levels of 35 mg, 70 mg, 140 mg, 280 mg, 560 mg, and 1120 mg. The dose of briciclib in the RPTD Confirmation Stage will be the dose as determined during the escalation stage. At each dose level, briciclib will be administered as a 2-hour intravenous infusion, once-a-week per 3-week cycles.
Other Name: ON 013105
- Number of patients with adverse events [ Time Frame: Up to 1 year ]Adverse events will be grouped by system organ class (SOC) and preferred term (PT) using the most recent version of the Medical Dictionary for Regulatory Activities (MedDRA), and will be summarized by worst grade according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
- Number of patients with Dose Limiting Toxicity (DLT) [ Time Frame: Up to 3 weeks ]Dose-limiting toxicity is defined as an adverse event that is considered to be drug-related and meets one of the Protocol definitions.
- Maximum Tolerated Dose [ Time Frame: 3 weeks ]Maximum Tolerated Dose (MTD) will be defined during the Dose Escalation Stage based on evaluation of the number of patients with Dose-limiting Toxicity (DLT). The MTD will be used to determine the Recommended Phase 2 Dose (RPTD).
- Concentration of briciclib in the plasma [ Time Frame: 24 hours ]The amount of briciclib in the plasma of patients in the Recommended Phase 2 Dose (RPTD) Confirmation stage only will be measured by a validated Liquid Chromatography-Mass Spectroscopy (LC-MS) method. Pharmacokinetic parameters will be derived from the concentration versus time values.
- Concentration of briciclib in the urine [ Time Frame: 24 hours ]The amount of briciclib in the urine of patients in the Recommended Phase 2 Dose (RPTD) Confirmation stage only will be measured by a validated Liquid Chromatography-Mass Spectroscopy (LC-MS) method. Pharmacokinetic parameters will be derived from the concentration versus time values.
- Change in size of tumors [ Time Frame: Up to 1 year ]Change in the overall tumor will be determined from the tumor burden at Baseline following Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Biomarker Concentration or Activity [ Time Frame: Up to 1 year ]An exploratory objective of this study is to evaluate the biological effect of briciclib on cell-cycle pathways, cyclin D1, and other potential surrogate biomarker(s) of efficacy and/or toxicity in tumor tissue and peripheral blood mononuclear cells (PBMNC).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168725
|United States, Colorado|
|University of Colorado Hospital Anschutz Medical Campus|
|Aurora, Colorado, United States, 80045|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|United States, Tennessee|
|Sarah Cannon Research Institute|
|Nashville, Tennessee, United States, 37203|
|Principal Investigator:||Antonio Jimeno, MD, PhD||University of Colorado, Denver|