Compassionate Use Study of Tenalisib (RP6530)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-28

Study Completion Date

2023-03-25

Brief Summary

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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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Detailed Description

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Conditions

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Hematological Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tenalisib

Participants receive Tenalisib (RP6530) BID Orally

Group Type EXPERIMENTAL

Tenalisib

Intervention Type DRUG

BID Orally

Interventions

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Tenalisib

BID Orally

Intervention Type DRUG

Other Intervention Names

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RP6530

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No