A Phase 1 Study Evaluating the Safety, PK, and Clinical Effects of PT-112 in Subjects With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT02266745|
Recruitment Status : Recruiting
First Posted : October 17, 2014
Last Update Posted : October 22, 2020
This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, and PK (pharmacokinetics).
The Dose Escalation Phase and is no longer enrolling. The Dose Expansion Phase currently has two cohorts: one for the study of PT-112 in patients with thymoma and thymic carcinoma, and the second in the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC).
Condition or disease: Advanced Solid Tumors; Thymoma and Thymic Carcinoma; Metastatic Castrate Resistant Prostate Cancer (mCRPC) Intervention/treatment: Drug: PT-112 Injection Phase: Phase 1/2
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors TET: Thymic Epithelia Tumors CRPC mCRPC Metastatic Castrate-resistant Prostate Cancer PT-112 Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site||Drug: PT-112 Injection||Phase 1|
This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase, and the Dose Expansion Phase
The Dose Escalation Phase is no longer enrolling. The Dose Expansion Phase is commencing in the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||October 31, 2021|
Experimental: PT-112 injection
PT-112 Injection, administered by intravenous infusion
Drug: PT-112 Injection
Other Name: PT-112
- Determine the safety and tolerability, Dose Limiting Toxicity(ies) (DLT), Maximum Tolerated Dose (MTD), and recommended Phase 2 dose(s) (RP2D) [ Time Frame: 28-day cycle ]The primary endpoint is to determine the safety profile and MTD of PT-112 Injection. Assessments will include drug exposure; characterization of DLTs; characterization of the type, incidence, severity, seriousness, and relationship to treatment of adverse events (AEs), and effects on vital signs and laboratory parameters.
- Assess the pharmacokinetic (PK) profile [ Time Frame: First 28-day cycle ]PK (pharmacokinetic) parameters, including but not limited to area under the curve (AUC), maximum plasma concentration (Cmax), trough plasma concentration (Cmin), time to maximum plasma concentration (Tmax), and plasma half-life (T1/2) will be determined.
- Document any observed anti-tumor effects [ Time Frame: Day 1, Day 56 and every 56 days subsequently ]Subjects will be assessed for clinical activity of PT-112 Injection every 2 cycles by appropriate physical examination or computed tomography imaging techniques, using RECIST v1.1; and, where appropriate, informative tumor markers every cycle.
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): NCT02266745
|Contact: Jason Summa||(617) email@example.com|
|Contact: Mariam Mahbobfirstname.lastname@example.org|
|United States, Arizona|
|Phoenix, Arizona, United States, 85054|
|United States, Colorado|
|Aurora, Colorado, United States, 80045|
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02215|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|New York, New York, United States, 10065|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Daniel D. Karp, MD|
|Principal Investigator:||Daniel D. Karp, MD||M.D. Anderson Cancer Center|