Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01379209 · ClinicalTrials.gov registry record · Phase 1
Intravenous Administration of RGI-2001 in Patient Undergoing Allogenic Hematopoietic Stem Cell Transplantation (AHSCT)
A Phase 1 study, sponsored by Regimmune Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
NCT01379209 is a Phase 1 study that has completed, run by Regimmune Corporation. The registered enrollment target is 68 participants.
The verdict
NCT01379209, a Phase 1 study, has completed, sponsored by Regimmune Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
Study Summary
The clinical trial is a Phase 1/2a, open-label, multi-center, dose-escalation study to evaluate the safety, tolerability and pharmacokinetic profile of RGI-2001 in patients undergoing AHSCT, with radiation or non-radiation myeloablative preparative treatment. The study will be separated into two parts; a dose escalation phase to assess safety, followed by a large expansion phase to further evaluate the pharmacologic effects of either a Maximum Tolerated Dose, Maximum Feasible Dose or optimal pharmacologically active dose of RGI-2001. The initial dose escalation safety portion of the study (Part 1) will include higher risk patients and limit the unrelated donor transplants. After safety is established in part 1 of the study, the second portion of the study will expand the enrollment criteria and allow transplantation by either related or unrelated donors. This study will endeavor to identify the dose range at which RGI-2001 has an acceptable safety profile, at which biologic activity is observed, and to guide possible dose levels to utilize in later phase studies based on biological activity.
Interventions
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
- PROCEDURE Allogeneic Bone Marrow Transplantation
- DRUG RGI-2001
- DRUG Calcineurin Inhibitors
- DRUG Conditioning Regimen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2011-09 |
| Est. Completion | 2017-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01379209
The ClinicalTrials.gov registry entry for NCT01379209 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regimmune Corporation, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Allogeneic Hematopoietic Stem Cell Transplantation is the first listed.
NCT01379209 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01379209 about?
NCT01379209 is a clinical study titled "Intravenous Administration of RGI-2001 in Patient Undergoing Allogenic Hematopoietic Stem Cell Transplantation (AHSCT)". The clinical trial is a Phase 1/2a, open-label, multi-center, dose-escalation study to evaluate the safety, tolerability and pharmacokinetic profile of RGI-2001 in patients undergoing AHSCT, with radiation or non-radiation myeloablative preparative treatment. The study will be separated into two pa...
What is the current status of trial NCT01379209?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2011-09. Estimated completion is 2017-04.
What interventions are being tested in trial NCT01379209?
The interventions under investigation include: Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Allogeneic Bone Marrow Transplantation (PROCEDURE), RGI-2001 (DRUG), Calcineurin Inhibitors (DRUG), Conditioning Regimen (DRUG).
Who is sponsoring clinical trial NCT01379209?
This trial is sponsored by Regimmune Corporation, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.