Clinical trial NCT03711604: Compassionate Use Study of Tenalisib (RP6530)
Official title: An Open Label, Compassionate Use Study of Tenalisib (RP6530) in Patients Currently Receiving Treatment on Tenalisib Trials in Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hematological Malignancies
Keywords: Hematological Malignancies
Tenalisib
RP6530
Compassionate Use
Lead sponsor: Rhizen Pharmaceuticals SA
Sponsor class: INDUSTRY
First posted: 2018-10-18
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment-related Adverse Events
timeFrame: 2 years
measure: Time to Disease Progression
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, Hellen Diller Family Comprehensive Cancer Center
state: California
city: Denver
country: United States
facility: Division of Hematology, University of Colorado,
state: Colorado
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute
state: Ohio
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Tbilisi
country: Georgia
facility: Ltd. M.Zodelava Hematology Centre
city: Tbilisi
country: Georgia
facility: Medivest - Institute of Hematology and Transfusiology
city: Chorzów
country: Poland
facility: Silesian Healthy Blood Clinic Grosicki, Grosicka Sp.J.
Study officials:
References: