Trials / Active Not Recruiting
Active Not RecruitingNCT02266745
A Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts
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 and Subsequent Dose Expansion Cohorts
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 109 (estimated)
- Sponsor
- Promontory Therapeutics Inc. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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 is complete and no longer enrolling. The Dose Expansion Phase has two cohorts: one cohort for the study of PT-112 in patients with thymoma and thymic carcinoma (Cohort A), and one cohort for the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC) (Cohort D).
Detailed description
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 and the Dose Expansion Thymoma Cohort are complete and no longer enrolling. The Dose Expansion Phase of the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC) is open and enrolling.
Conditions
- Advanced Solid Tumors
- CRPC
- mCRPC
- Metastatic Castrate-resistant Prostate Cancer
- PT-112
- Prostatic Neoplasms
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PT-112 Injection |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2024-08-01
- Completion
- 2025-04-01
- First posted
- 2014-10-17
- Last updated
- 2024-04-05
Locations
25 sites across 2 countries: United States, France
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02266745. Inclusion in this directory is not an endorsement.