Compassionate Use Study of Tenalisib (RP6530)

NCT03711604 | Completed Phase 1 Results FDA Drug

• 1 other identifier: RP6530-1803
• Study Type: interventional
• Target: 17
• Locations: 3 countries
• Sites: 7

Brief 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

Hematological Malignancies

Keywords

Hematological Malignancies; Tenalisib; RP6530; Compassionate Use

Outcome Measures

Primary Outcomes (2)

• Treatment-related Adverse Events

  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 years

• Time to Disease Progression

  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.

  2 years

Study Arms (1)

Tenalisib

EXPERIMENTAL

Participants receive Tenalisib (RP6530) BID Orally

Drug: Tenalisib

Interventions

Tenalisib DRUG

BID Orally

Also known as: RP6530

Tenalisib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rhizen Pharmaceuticals SA: lead

Study Sites (7)

University of California, Hellen Diller Family Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

Division of Hematology, University of Colorado,

Denver, Colorado, 80045, United States

Location

Cleveland Clinic Taussig Cancer Institute

Cleveland, Ohio, 44195, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Ltd. M.Zodelava Hematology Centre

Tbilisi, Georgia

Location

Medivest - Institute of Hematology and Transfusiology

Tbilisi, Georgia

Location

Silesian Healthy Blood Clinic Grosicki, Grosicka Sp.J.

Chorzów, 41-503, Poland

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

tenalisib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Limitations and Caveats

The primary purpose of this study is to offer patients, who completed a Rhizen-sponsored clinical study without progression, the opportunity to continue to receive Tenalisib on a compassion basis. Thus, the assessments were done in open-label manner.

Results Point of Contact

• Title: Dr.Prajak Barde
• Organization: Rhizen Pharmaceuticals AG

pjb@rhizen.com

9820503970

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 18, 2018
• Study Start: November 28, 2018
• Primary Completion: March 25, 2023
• Study Completion: March 25, 2023
• Last Updated: May 8, 2024
• Results First Posted: May 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1); GE (2); US (4)