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NCT03711604 · ClinicalTrials.gov registry record · Phase 1

Compassionate Use Study of Tenalisib (RP6530)

A Phase 1 study of Hematological Malignancies, sponsored by Rhizen Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
17
Enrollment target
7
Study locations

NCT03711604: Completed Phase 1 study of Hematological Malignancies, sponsored by Rhizen Pharmaceuticals.

NCT03711604 is a Phase 1 study of Hematological Malignancies that has completed, run by Rhizen Pharmaceuticals. The registered enrollment target is 17 participants, below the 775-participant average among 16 other Hematological Malignancies trials with a reported enrollment target (98% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03711604, a Phase 1 study of Hematological Malignancies, has completed, sponsored by Rhizen Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
17 participants
Enrollment target
7
Study locations

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.

Primary Outcome

To evaluate the safety and tolerability of Tenalisib as single agent. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

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
Rhizen Pharmaceuticals

7 total trials

What the finished NCT03711604 record still lists

NCT03711604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 775-participant average among 16 other Hematological Malignancies trials with a reported enrollment target (98% lower).

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.

NCT03711604 lists 7 locations in 5 states (Other, California, Colorado).

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.

What interventions are being tested in trial NCT03711604?

The interventions under investigation include: Tenalisib (DRUG).

Who is sponsoring clinical trial NCT03711604?

This trial is sponsored by Rhizen Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Hematological Malignancies

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03711604's enrollment target sits among peer trials

17 17th of 16 the lowest of 16 other Hematological Malignancies trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hematological Malignancies 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03711604, the US trial registry maintained by the National Library of Medicine. NCT03711604 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.