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NCT02266745 · ClinicalTrials.gov registry record · Phase 2
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 2 study of Advanced Solid Tumors and Prostatic Neoplasms, sponsored by Promontory Therapeutics.
- Active
- Registry status
- Phase 2
- Development phase
- 109
- Enrollment target
- 20
- Study locations
NCT02266745: Active Phase 2 study of Advanced Solid Tumors and Prostatic Neoplasms, sponsored by Promontory Therapeutics.
NCT02266745 is a Phase 2 study of Advanced Solid Tumors and Prostatic Neoplasms that is active but no longer recruiting, run by Promontory Therapeutics. The registered enrollment target is 109 participants, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02266745, a Phase 2 study of Advanced Solid Tumors and Prostatic Neoplasms, is active but no longer recruiting, sponsored by Promontory Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 109 participants
- Enrollment target
- 20
- Study locations
Study 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).
Conditions Studied
Interventions
- DRUG PT-112 Injection
Study Locations (20)
Other
- Besançon - Besançon
- Bordeaux - Bordeaux
- Caen - Caen
Arizona
- Arizona - Phoenix
- Tucson - Tucson
Florida
- Jacksonville - Jacksonville
- Orlando - Orlando
Minnesota
- Minneapolis - Minneapolis
- Rochester - Rochester
New York
- Brooklyn - Brooklyn
- New York - New York
California
- Duarte - Duarte
Colorado
- Colorado - Aurora
Indiana
- Indianapolis - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2014-07 |
| Est. Completion | 2025-04-01 |
| Phase | Phase 2 |
What the registry record for NCT02266745 still lists
NCT02266745 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (45% lower).
The record links to 9 conditions, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which PT-112 Injection is the first listed.
NCT02266745 names 20 study sites across 14 states, led by Other, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT02266745 about?
NCT02266745 is a clinical study titled "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". 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 Inject...
What is the current status of trial NCT02266745?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 109 participants. The study started on 2014-07. Estimated completion is 2025-04-01.
What conditions does trial NCT02266745 study?
This clinical trial studies the following conditions: Advanced Solid Tumors, Prostatic Neoplasms, Neoplasms by Site, Urogenital Neoplasms, mCRPC.
What interventions are being tested in trial NCT02266745?
The interventions under investigation include: PT-112 Injection (DRUG).
Who is sponsoring clinical trial NCT02266745?
This trial is sponsored by Promontory Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02266745 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02266745's enrollment target sits among peer trials
109 79th of 144 higher than 66 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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