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COMPLETED Phase 1

Compassionate Use Study of Tenalisib (RP6530)

NCT03711604 · View on ClinicalTrials.gov ↗

Study Summary

Tenalisib has been evaluated as an investigational new drug in number of early clinical studies in patients with relapsed/refractory hematological malignancies and demonstrated acceptable safety and promising efficacy in these patients. Since these advanced relapsed/refractory patients have limited therapeutic options, it is reasonable to continue Tenalisib in responding patients post completion of their participation in previous clinical studies.

Conditions Studied

Interventions

  • DRUG Tenalisib

Study Locations (7)

Other

  • Ltd. M.Zodelava Hematology Centre — Tbilisi
  • Medivest - Institute of Hematology and Transfusiology — Tbilisi
  • Silesian Healthy Blood Clinic Grosicki, Grosicka Sp.J. — Chorzów

California

  • University of California, Hellen Diller Family Comprehensive Cancer Center — San Francisco

Colorado

  • Division of Hematology, University of Colorado, — Denver

Ohio

  • Cleveland Clinic Taussig Cancer Institute — Cleveland

Texas

  • The University of Texas MD Anderson Cancer Center — Houston

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2018-11-28
Est. Completion 2023-03-25
Phase Phase 1

Sponsor

Rhizen Pharmaceuticals

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03711604

The ClinicalTrials.gov registry entry for NCT03711604 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rhizen Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Hematological Malignancies appearing as the primary indexed condition, and to 1 intervention — of which Tenalisib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03711604 reports 7 study locations spanning 5 distinct geographic areas — top geographies include Other, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03711604 about?

NCT03711604 is a clinical study titled "Compassionate Use Study of Tenalisib (RP6530)". Tenalisib has been evaluated as an investigational new drug in number of early clinical studies in patients with relapsed/refractory hematological malignancies and demonstrated acceptable safety and promising efficacy in these patients. Since these advanced relapsed/refractory patients have limited ...

What is the current status of trial NCT03711604?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2018-11-28. Estimated completion is 2023-03-25.

What conditions does trial NCT03711604 study?

This clinical trial studies the following conditions: Hematological Malignancies. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03711604?

The interventions under investigation include: Tenalisib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03711604?

This trial is sponsored by Rhizen Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03711604 being conducted?

This trial has 7 study locations across California, Colorado, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial