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NCT03808558 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of TVB-2640 in KRAS Non-Small Cell Lung Carcinomas
A Phase 2 study of KRAS Gene Mutation, sponsored by David E Gerber.
- Active
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 2
- Study locations
NCT03808558: Active Phase 2 study of KRAS Gene Mutation, sponsored by David E Gerber.
NCT03808558 is a Phase 2 study of KRAS Gene Mutation that is active but no longer recruiting, run by David E Gerber. The registered enrollment target is 18 participants, below the 71-participant average among 3 other KRAS Gene Mutation trials with a reported enrollment target (75% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03808558, a Phase 2 study of KRAS Gene Mutation, is active but no longer recruiting, sponsored by David E Gerber.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a prospective one-arm, two-stage phase 2 trial of TVB-2640 in KRAS mutant NSCLC patients. 13 patients will be treated with a minimum of 1 cycle of TVB-2640 therapy over 8 weeks.
Primary Outcome
Determine Disease control rate of TVB-2640 in KRAS mutant NSCLC patients through RECIST and toxicity profile. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), \>=20% increase in the sum of diameters of target lesions; Stable Disease (SD): Neither sufficient
Conditions Studied
Interventions
- DRUG TVB-2640
Study Locations (2)
Ohio
- University of Cincinnati - Cincinnati
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-09-11 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 2 |
What the registry record for NCT03808558 still lists
NCT03808558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 71-participant average among 3 other KRAS Gene Mutation trials with a reported enrollment target (75% lower).
The record links to 1 condition, with KRAS Gene Mutation appearing as the primary indexed condition, and to 1 intervention - of which TVB-2640 is the first listed.
NCT03808558 reports a single indexed study location in Ohio, Texas.
Frequently Asked Questions
What is clinical trial NCT03808558 about?
NCT03808558 is a clinical study titled "Phase 2 Study of TVB-2640 in KRAS Non-Small Cell Lung Carcinomas". This is a prospective one-arm, two-stage phase 2 trial of TVB-2640 in KRAS mutant NSCLC patients. 13 patients will be treated with a minimum of 1 cycle of TVB-2640 therapy over 8 weeks.
What is the current status of trial NCT03808558?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2019-09-11. Estimated completion is 2026-12-01.
What conditions does trial NCT03808558 study?
This clinical trial studies the following conditions: KRAS Gene Mutation.
What interventions are being tested in trial NCT03808558?
The interventions under investigation include: TVB-2640 (DRUG).
Who is sponsoring clinical trial NCT03808558?
This trial is sponsored by David E Gerber, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03808558 being conducted?
This trial has 2 study locations across Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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