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Completed

NCT Number: NCT03711604

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 therapeutic options, it is reasonable to continue Tenalisib in responding patients post completion of their participation in previous clinical studies.

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Key information

Conditions

Hematological Malignancies Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Ltd. M.Zodelava Hematology Centre, Tbilisi, Georgia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must be currently receiving treatment with Tenalisib on a previously approved protocol.
  • Patients must have had at least one efficacy evaluation in previous study and should have achieved either SD, PR or CR.
  • Patients must have completed at least 6 cycles of Tenalisib in previous study
  • Ability to swallow and retain oral medication.
  • Female patients of child-bearing potential must consent to use two medically acceptable methods of contraception.
  • Male patients must be willing to use adequate contraceptive measures
  • Willingness and ability to comply with trial and follow-up procedures.
  • Willingness to provide new written informed consent.

Exclusion criteria

  • Patient has been discontinued from their previous Tenalisib study 4 weeks prior to entering the compassionate use trial.
  • Patient progressed while receiving Tenalisib therapy in his/her previous study.
  • Pregnant or lactating woman.
  • Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.
  • Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol.

Treatment and study plan

Tenalisib

Drug

BID Orally

Other names: RP6530

Primary outcomes

  1. Treatment-related Adverse Events

    Time frame: 2 years

    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

  2. Time to Disease Progression

    Time frame: 2 years

    Number of patients with a time to progression. The time to progression is calculated from the day of enrollment in the study to disease progression or death due to any cause.

Sponsors and collaborators

Lead sponsor

Rhizen Pharmaceuticals SA

Industry

Registry information

Official study title

An Open Label, Compassionate Use Study of Tenalisib (RP6530) in Patients Currently Receiving Treatment on Tenalisib Trials in Hematological Malignancies

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Oct 18, 2018
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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