- |||||||||| tenalisib (RP6530) / Rhizen
Trial completion, Trial completion date, Trial primary completion date, Metastases: Efficacy and Safety of Tenalisib (RP6530), a PI3K ?/? and SIK3 Inhibitor, in Patients With Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - May 17, 2023 P2, N=40, Completed, Overall, tenalisib and romidepsin combination demonstrated a favorable safety and efficacy profile supporting its further development for relapsed/refractory TCL. Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Mar 2023 | Trial primary completion date: Dec 2022 --> Mar 2023
- |||||||||| Treatment of non-Hodgkin lymphoma with targeted drugs may include: * PI3K inhibitors, such as duvelisib, tenalisib, and buparlisib, * BTK (Bruton tyrosine kinase) inhibitors, such as ibrutinib, * BSL-2 inhibitors, such as venetoclax, * Janus kinase inhibitors such as ruxolitinib, (Twitter) - Apr 8, 2023
- |||||||||| CN1 / Curon Biopharma, tenalisib (RP6530) / Rhizen
Enrollment change, Trial completion date, Trial termination, Combination therapy: A Study of CN1 in Combination With CN401 in Adult Patients With Relapsed/Refractory Lymphoid Malignancies (clinicaltrials.gov) - Oct 24, 2022 P1/2, N=7, Terminated, Clinical trial information: NCT05021900. N=78 --> 7 | Trial completion date: Jul 2023 --> Sep 2022 | Recruiting --> Terminated; Sponsor decided that there was no benefit in the drug treatment and due to company change in landscape in the new year.
- |||||||||| tenalisib (RP6530) / Rhizen
Enrollment change, Trial completion date, Trial primary completion date: Compassionate Use Study of Tenalisib (RP6530) (clinicaltrials.gov) - Nov 2, 2021 P1/2, N=17, Enrolling by invitation, Based on these encouraging results, further development of this combination in PTCL patients in being planned. N=10 --> 17 | Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Oct 2021 --> Oct 2022
- |||||||||| tenalisib (RP6530) / Rhizen
Trial completion date, Trial primary completion date: Compassionate Use Study of Tenalisib (RP6530) (clinicaltrials.gov) - Dec 4, 2020 P1/2, N=10, Enrolling by invitation, Trial primary completion date: Dec 2020 --> May 2021 Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Oct 2020 --> Oct 2021
- |||||||||| azacitidine / Generic mfg., tenalisib (RP6530) / Rhizen
[VIRTUAL] THERAPEUTIC POTENTIAL OF TENALISIB, A PI3K DELTA/GAMMA PLUS SIK-3 INHIBITOR, IN HEMATOLOGICAL MALIGNANCIES () - May 16, 2020 - Abstract #EHA2020EHA_748; A Phase 1/2 study evaluating the safety and efficacy of Tenalisib in combination with Romidepsin in relapsed/refractory T-cell lymphoma is currently ongoing in the USA...Cell growth following incubation (72 h) with IN0385 as a single agent or in combination with Azacytidine, or Venetoclax was determined in the AML lines: THP-1, U937, and MV-4-11...Gene expression studies in specific cell types and xenograft models are currently underway to further elucidate the role and utility of IN0385 in other hematological malignancies. A Phase-1 trial in relapsed/refractory AML is planned.
- |||||||||| tenalisib (RP6530) / Rhizen
Enrollment status: Compassionate Use Study of Tenalisib (RP6530) (clinicaltrials.gov) - Oct 29, 2019 P1/2, N=10, Enrolling by invitation, Currently, a phase I/II combination study to further evaluate safety and efficacy with romidepsin is ongoing in this target population. Recruiting --> Enrolling by invitation
- |||||||||| Jakafi oral (ruxolitinib) / Novartis, Incyte
Journal: Development of new agents for peripheral T-cell lymphoma. (Pubmed Central) - Jun 9, 2019 In addition, mogamulizumab (anti-CC chemokine receptor 4 antibody), chidamide (histone deacetylase inhibitor), and forodesine (purine nucleoside phosphorylase inhibitor) have been approved in Asian countries, including China, and Japan...However, these are not a curative option when used as a single agent. Further clinical developments are expected, comprising 1) combination therapies of new agents with cytotoxic chemotherapies; 2) "novel-novel" combinations; 3) immune therapies, including chimeric antigen receptor T-cell therapy; and 4) predictive marker analysis.
- |||||||||| tenalisib (RP6530) / Rhizen
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Combination therapy: Safety and Efficacy Study of Tenalisib (RP6530) in Combination With Pembrolizumab in Relapsed or Refractory cHL (clinicaltrials.gov) - Feb 26, 2019 P1/2, N=2, Terminated, Initiation date: Dec 2018 --> Mar 2019 N=57 --> 2 | Trial completion date: Dec 2019 --> Feb 2019 | Recruiting --> Terminated | Trial primary completion date: Aug 2019 --> Feb 2019; At this point, the current study in HL does not fit into clinical development and regulatory strategy.
- |||||||||| tenalisib (RP6530) / Rhizen
Trial completion: Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma (clinicaltrials.gov) - Dec 13, 2018 P1, N=58, Completed, N=57 --> 2 | Trial completion date: Dec 2019 --> Feb 2019 | Recruiting --> Terminated | Trial primary completion date: Aug 2019 --> Feb 2019; At this point, the current study in HL does not fit into clinical development and regulatory strategy. Active, not recruiting --> Completed
|