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NCT02834780 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma
A Phase 1 study of Hepatocellular Carcinoma and Liver Cancer, sponsored by H3 Biomedicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 128
- Enrollment target
- 20
- Study locations
NCT02834780: Completed Phase 1 study of Hepatocellular Carcinoma and Liver Cancer, sponsored by H3 Biomedicine.
NCT02834780 is a Phase 1 study of Hepatocellular Carcinoma and Liver Cancer that has completed, run by H3 Biomedicine. The registered enrollment target is 128 participants, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02834780, a Phase 1 study of Hepatocellular Carcinoma and Liver Cancer, has completed, sponsored by H3 Biomedicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 128 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics of H3B-6527.
Primary Outcome
DLTs were defined as any of the following toxicities: Hematology, gastrointestinal, renal, hepatic or nonhematologic toxicities occurring during Cycle 1 in Dose Escalation Phase only and judged by the investigator as related to study drug. This included any Grade 4: neutropenia that does not resolve to Grade less than or equal to (\<=) 2 within 7 days, thrombocytopenia, anemia of any duration, diarrhea and/or vomiting irrespective of prophylaxis or appropriate treatment; Grade 3: thrombocytopeni
Conditions Studied
Interventions
- DRUG H3B-6527
Study Locations (20)
California
- USC/Norris Comprehensive Cancer Center - Los Angeles
- Hoag Memorial Hospital Presbyterian - Newport Beach
- UC Irvine Medical Center - Orange
- UCLA Medical Center - Santa Monica
Texas
- Simmons Comprehensive Cancer Center - Dallas
- University of Texas Southwestern Medical Center - Dallas
Other
- Universitair Ziekenhuis Gent - Ghent
- Institut Bergonié - Bordeaux
District of Columbia
- Georgetown Unversity Lombardi Comprehensive Cancer Center - Washington D.C.
Illinois
- Northwestern Unversity - Chicago
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- Barbara Ann Karmanos Cancer Institute - Detroit
New Jersey
- John theurer Cancer Center at Hackensack University Medical Center - Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2016-12-28 |
| Est. Completion | 2022-02-23 |
| Phase | Phase 1 |
What the finished NCT02834780 record still lists
NCT02834780 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (50% lower).
The record links to 6 conditions, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which H3B-6527 is the first listed.
NCT02834780 names 20 study sites across 15 states, led by California, Texas, Other.
Frequently Asked Questions
What is clinical trial NCT02834780 about?
NCT02834780 is a clinical study titled "Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma". The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics of H3B-6527.
What is the current status of trial NCT02834780?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 128 participants. The study started on 2016-12-28. Estimated completion is 2022-02-23.
What conditions does trial NCT02834780 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma, Liver Cancer, Advanced Hepatocellular Carcinoma, Liver Neoplasms, Hepatic Cancer.
What interventions are being tested in trial NCT02834780?
The interventions under investigation include: H3B-6527 (DRUG).
Who is sponsoring clinical trial NCT02834780?
This trial is sponsored by H3 Biomedicine, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02834780 being conducted?
This trial has 20 study locations across California, District of Columbia, Illinois, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02834780's enrollment target sits among peer trials
128 49th of 145 higher than 97 of 145 other Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular Carcinoma 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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