This Study is to Evaluate OBI-3424 Safe and Effective Treatment Dose in Subjects With Hepatocellular Carcinoma or Castrate Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03592264|
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : May 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Hepatocellular Carcinomas (HCC) Castrate-resistant Prostate Cancer (CRPC)||Drug: OBI-3424||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of OBI-3424 in Subjects With Solid Tumors, Hepatocellular Carcinoma and Castrate-Resistant Prostate Cancer|
|Actual Study Start Date :||June 7, 2018|
|Estimated Primary Completion Date :||August 31, 2021|
|Estimated Study Completion Date :||November 30, 2021|
Experimental: Dose escalation phase
OBI-3424 (1.0 mg/m^2 to 24.0 mg/m^2) will be administered by IV infusion on Days 1 and 8 of each 21-day cycle to determine the MTD and RP2D.
liquid formulation for Intravenous infusion
Experimental: Cohort expansion phase
Once the MTD and RP2D is determined then OBI-3424 (dosage TBD) will be administered by IV infusion on Days 1 and 8 of each 21-day cycle.
liquid formulation for Intravenous infusion
- Incidence and severity of adverse events (AEs) [ Time Frame: Adverse events will be noted as it occurs. Timeframe for measure begins after first administration of study drug until 30 days after last dose of study drug. Study duration defined as up to 2 years. ]Adverse events will be graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
- Assess safety changes in electrocardiogram (ECG) [ Time Frame: Day 1 Cycles 1 and 2 (each cycle is 21 days) ]Resting 12-lead ECGs will be obtained from all subjects' pre-OBI-3424 infusion and within 15 minutes post-OBI-3424 infusion in order to assess any impact OBI-3424 may have on the QT interval as assessed by the Fridericia's Correction Formula (QTcF).
- Assess safety changes of body weight. [ Time Frame: Day 1 of each cycle (there are 34 cycles; 21 days for each cycle) ]If during treatment a subject's body weight changes by >10%, the dose should be adjusted.
- Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Throughout Cycle 1 (21 days for each cycle) ]A DLT is defined as the occurrence of Grade 3/4 adverse events within the first cycle (the first 21 days) of treatment that are considered by the investigator to be at least possibly related to OBI-3424.
- Define the Recommended Phase 2 Dose (RP2D) [ Time Frame: Days 1 and 8 of each cycle (all 34 cycles and there are 21 days for each cycle) ]Determination of the MTD, based on the frequently of DLTs observed in Cycle 1 in subjects recruited to the Dose Escalation Phase.
- Pharmacokinetics (PK) - Time to maximum concentration (Tmax) [ Time Frame: Days 1 and 8 of Cycle 1 (first cycle of 34 cycles and there are 21 days for each cycle) ]Tmax of OBI-3424 and OBI-2660 will be computed for each subject where possible.
- PK - Maximum peak plasma concentration (Cmax) [ Time Frame: Days 1 and 8 of Cycle 1 (first cycle of 34 cycles and there are 21 days for each cycle) ]Cmax of OBI-3424 and OBI-2660 will be computed for each subject where possible.
- PK - The magnitude of the slope of the linear regression of the log concentration vs. time profile during the terminal phase (Kel) [ Time Frame: Days 1 and 8 of Cycle 1 (first cycle of 34 cycles and there are 21 days for each cycle) ]Kel of OBI-3424 and OBI-2660 will be computed for each subject where possible.
- PK - Half-life (T1/2) [ Time Frame: Days 1 and 8 of Cycle 1 (first cycle of 34 cycles and there are 21 days for each cycle) ]T1/2 computed as ln (2)/Kel of OBI-3424 and OBI-2660 will be computed for each subject where possible.
- PK - Area under the concentration-time curve (AUClast) [ Time Frame: Days 1 and 8 of Cycle 1 (Cycle 1 is 21 days) ]AUClast from Hour 0 through the last quantifiable concentration time (LQCT), where LQCT is the time at which the last sample with a quantifiable concentration was drawn
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): NCT03592264
|Contact: Joy Chifirstname.lastname@example.org|
|Contact: Liz Yu||+886-2-27866589 ext email@example.com|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Apostolia Tsimberidou, MD, PHD||M.D. Anderson Cancer Center|