Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

All Drugs and Chemicals

Tenalisib

Phosphoinositide-3 Kinase Inhibitors

Enzyme Inhibitors

Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles

The trial is a Phase II, open label, Simon's two stage study design to evaluate the efficacy and safety of Tenalisib in patients with CLL who have relapsed or are refractory after at least one prior therapy.

Tenalisib is a highly specific and orally available dual PI3K δ/γ inhibitor. Pre-clinical experiments demonstrated that Tenalisib is highly effective in killing primary CLL cells in vitro. A Phase II study is planned to evaluate the efficacy and safety of Tenalisib in patients with relapsed/refractory CLL.

Efficacy and Safety of Tenalisib (RP6530) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

A Phase 2, Open Label Study to Assess the Efficacy and Safety of Tenalisib (RP6530), a Novel PI3K Dual δ/γ Inhibitor, in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

Per Response Evaluation Criteria as defined by iwCLL guideline for CLL: Complete Response (CR), all parameters should be regressed to normal (lymph nodes ≥ 1.5 cm; spleen size \<13 cm; liver size normal; no constitutional symptoms; circulating lymphocyte count normal; platelet count ≥ 100 x 109 /L; Hemoglobin ≥ 11.0 g/dL). For partial response, at least two of the parameters (lymph nodes, liver and/or spleen size, constitutional symptoms, circulating lymphocyte count) and one parameter (platelet count, hemoglobin) need to improve if previously abnormal; Overall Response (OR) = CR + PR."

Duration of response (DOR): DOR is defined as the interval from the first documentation of CR/PR to the first documentation of definitive disease progression or death from any cause.

Progression disease is defined using iwCLL criteria as at least one of the criteria of parameters (i.e., lymph nodes increase ≥ 50% from baseline or from response; liver and/or spleen size increase ≥ 50% from baseline or from response; any constitutional symptoms; circulating lymphocyte count increase ≥ 50% over baseline) or criteria of parameters (i.e., platelet count decrease of ≥ 50% over baseline secondary to CLL; hemoglobin decrease of ≥ 50% over baseline secondary to CLL) should be met.

Summary of Treatment-Emergent Adverse Events-(Causality All). Patients will be monitored for adverse events and both related and as well as non-related adverse events will be captured during the study. All adverse events (irrespective of causality) will be reported.

Progression-free survival (PFS): PFS is defined as the interval from first dose to first documentation of definitive disease progression or death from any cause.

Rhizen Pharmaceuticals SA

Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles

Tenalisib: Tenalisib 800 mg BID, Orally

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Poland

Georgia

Bulgaria

Region of Enrollment

Prajak Barde MD

Patients who received at least 1 dose of study medication and provided at least 1 post-baseline efficacy assessment

Overall Response Rate (ORR)

Patients who received at least 1 dose of study medication and provide at least post-baseline efficacy assessment

Duration of Response (DoR)

Patients who received at least 1 dose of study medication

Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE Criteria v5.0

Patients who received at least 1 dose of study medication and provide at least 1 post-baseline efficacy assessment

Progression Free Survival (PFS)

Overall Study

Lymphoma

Hodgkin Disease

Lymphosarcoma

Hodgkin Lymphoma

Antineoplastic Agents

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants receive Tenalisib in escalating doses Orally BID and pembrolizumab as a fixed dose intravenously (IV) in Escalation and Expansion.

Tenalisib, BID, orally and Pembrolizumab 200 mg IV Q3W

To characterize safety, tolerability and to establish the maximum tolerated dose (MTD) for Tenalisib in combination with Pembrolizumab in patients with cHL.

Safety and Efficacy Study of Tenalisib (RP6530) in Combination With Pembrolizumab in Relapsed or Refractory cHL

An Open Label, Phase I/II Study to Evaluate the Safety and Efficacy of RP6530, a Novel PI3K δ/γ Dual Inhibitor Given in Combination With an Anti-PD-1 Therapy, Pembrolizumab in Adult Patients With Relapsed or Refractory cHL

The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle of treatment.

Assessment of Cmax in subjects treated with RP6530 and pembrolizumab combination

No of patients with partial and complete response

The time period from the response achieved in patient until the disease progression.

Progression-free survival was defined as the time from enrollment in the study to disease progression

Defined as improved outcome status (i.e Improve from PR to CR or from SD to PR)

Hematologic Neoplasms

Participants receive Tenalisib (RP6530) BID Orally

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.

Compassionate Use Study of Tenalisib (RP6530)

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

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

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.

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. This includes AE, SAE and adverse event of special interest.

Participants receive Tenalisib (RP6530) BID orally.

Tenalisib (RP6530)

Overall, 17 patients were enrolled in this study.

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.

Dr.Prajak Barde

Participants receive Tenalisib (RP6530) orally. Tenalisib (RP6530)

A total of 17 patients received at least one dose of Tenalisib.

Treatment-related Adverse Events

Time to Disease Progression

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Tenalisib will be administered 800mg BID, orally

Tenalisib will be administered 1200mg BID, orally

Phase II, randomized, open-label study, designed to evaluate the preliminary efficacy and safety of tenalisib at two dose levels in 40 patients with locally advanced or metastatic breast cancer.

Efficacy and Safety of Tenalisib (RP6530), a PI3K δ/γ and SIK3 Inhibitor, in Patients With Locally Advanced or Metastatic Breast Cancer

A Phase II, Multi-center, Randomized, Open-label, Two-arm Study to Assess the Efficacy and Safety of Tenalisib (RP6530), a PI3K δ/γ and SIK3 Inhibitor, in Patients With Locally Advanced or Metastatic Breast Cancer

It is defined as sum of CR, PR and SD rates

PFS is measured from the time of first dose of study drug to radiographic documentation of disease progression or death due to any cause.

Triple Negative Breast Neoplasms

Single agent Tenalisib \[RP6530 (PI3k delta, gamma and SIK3 inhibitor)\]

Prajak Barde, MD

Dr. Priyadarshini Lakshmi

Dr Pragnya Coca

Dr. Sudeep Gupta

Dr. Ashish Joshi

Dr. Tushar Patil

Dr. Saju SV

Dr. Sadashivudu Gundeti

This is a Phase II, open-label, single-arm, study, designed to evaluate the efficacy and safety of tenalisib in patients with metastatic TNBC, who have received at least one but not more than 3 prior therapies in a metastatic setting.

Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC)

A Phase II, Multi-center, Single-arm, Open-label Study to Assess the Efficacy and Safety of Tenalisib, a PI3K δ/γ, and SIK3 Inhibitor, in Patients With Metastatic Triple Negative Breast Cancer (TNBC)

It is defined as the percentage of patients achieving complete response (CR), partial response (PR), or stable disease (SD) for 16 weeks or longer.

It is defined as the time from the first dose to disease progression or death on study from any cause, whichever occurs first in patients who achieve CR, PR or SD for 16 weeks or longer.

Overall Response is defined as sum of CR and PR.

It is defined as the time from the first dose to disease progression or death on study from any cause, whichever occurs first.

Number of adverse events reported by the patients

Baseline mutational status and its correlation with efficacy

Incozen Therapeutics Pvt Ltd

Lymphoma, Non-Hodgkin

Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles

Tenalisib,

To assess the anti-tumor activity and safety of Tenalisib in patients with relapsed/refractory indolent Non-Hodgkin's Lymphoma (iNHL),

Efficacy and Safety Study of Tenalisib (RP6530), a Novel PI3K δ/γ Dual Inhibitor in Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (iNHL)

An Open Label, Phase II Study to Evaluate the Efficacy and Safety of Tenalisib (RP6530), a Novel PI3K δ/γ Dual Inhibitor in Adult Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (iNHL)

ORR is defined as sum of CR and PR rates and will be assessed according to the Lugano Classification for initial evaluation, staging, and response assessment of Non-Hodgkin lymphoma. (Cheson-2014)

CR rate will be assessed according to the Lugano Classification for initial evaluation, staging, and response assessment of non-Hodgkin lymphoma.

PFS is defined as the time of the first dose of Tenalisib to disease progression or death.

DoR is measured from the initial response to disease progression or death

Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.

Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles

Tenalisib,: BID, Orally

United States

Australia

Objective Response Rate (ORR)

Complete Response Rate

Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v4.0

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Peripheral T-cell Lymphoma

Anti-Infective Agents

Romidepsin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Histone Deacetylase Inhibitors

Participants receive Tenalisib in escalating doses daily Orally BID and Romidepsin in escalating doses intravenously on day 1, 8 and 15

To characterize safety, tolerability and to establish the maximum tolerated dose (MTD) of Tenalisib in combination with Romidepsin in patients with R/R T-cell lymphoma.

Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma

An Open Label, Phase I/II Study to Evaluate the Safety and Efficacy of Tenalisib (RP6530), a Novel PI3K δ/γ Dual Inhibitor Given in Combination With a Histone Deacetylase (HDAC) Inhibitor, Romidepsin in Adult Patients With Relapsed/Refractory T-cell Lymphoma

The DLTs will be classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.

Overall response (ORR) = CR + PR) was assessed according to the Lugano classification with PTCL and according to the modified Severity Weighted Assessment Tool (mSWAT)/Global assessment in patients with CTCL.

The time period from the response achieved in patient until the disease progression

Assessment of Cmax in subjects treated with Tenalisib and Romidepsin combination. Blood samples for measurement of RP6530 plasma concentrations were collected pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 11 hours after dosing on Day 8 of the first cycle. Maximum (peak) drug concentration (Cmax in nanograms/milliliter) was estimated using Single-Dose data.

Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.

RP6530 was administered at 400 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15

Dose escalation_Cohort 1

RP6530 was administered at 600 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15

Dose escalation_Cohort 2

RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15

Dose escalation_Cohort 3

Dose expansion_Group 1 (PTCL)

Dose expansion_Group 2 (CTCL)

Total

Dr. Ajit Nair

DLT assessment performed in patients who participated in dose escalation phase; A toxicity will be considered dose-limiting if it occurs during the first cycle (4-weeks) of treatment with Tenalisib and Romidepsin combination and is considered related to combination.

Number of Participants With and Without Dose Limiting Toxicities (DLTs)

Patients were considered for efficacy analysis as per protocol only if they had one post treatment efficacy assessment at C3D1

Overall Response Rate (ORR) With Tenalisib and Romidepsin Combination

RP6530 was administered at 600 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15

Dose expansion_Group1 (PTCL Patients)

Dose expansion_Group2 (CTCL Patients)

Duration of Response (DoR) is defined as the time when the measurement criteria are first met for PR or CR (whichever is reported first) until the date of documented disease progression or death. Overall number of Participants analyzed for DoR will be the participants who met response as CR or PR

Duration of Response (DoR) With Tenalisib and Romidepsin Combination

Peak Plasma Concentration (Cmax) of RP6530 at Cycle 1 day 8.

Maximum Observed Plasma Concentration (Cmax)

RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15

Antirheumatic Agents

Anti-Inflammatory Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Prednisone

Vincristine

Tenalisib will be administered orally twice daily in a 21-day cycle for 26 cycles (from cycle 1 to cycle 26), CHOP will be administered for 6 cycles (from Cycle 4 to Cycle 9) on Days 1 to 5 of each cycle.

This is a phase II open label, two-arm parallel design study of T-CHOP in patients with treatment naïve PTCL. Two doses of tenalisib (400 mg BID and 800 mg BID) will be evaluated in separate groups (Group 1: 400 mg BID and Group 2: 800mg BID) when given with standard regimen of CHOP, followed by single agent maintenance treatment with tenalisib for 1 year. Recruitment of 20 patients each will be done in both groups in parallel.

All eligible patients will start with a run-in period, in which single agent tenalisib will be administered for 3 cycles of 21 days each. Post run-in period, all patients will proceed to receive tenalisib and CHOP regimen for next 6 cycles. After completion of 6 cycles of T-CHOP treatment, maintenance therapy with tenalisib will be initiated in patients showing CR and PR. These patients will continue to receive single agent tenalisib for 1 year.

Study to Evaluate the Efficacy and Safety of Tenalisib, Given With CHOP Therapy for Front Line Treatment in Patients With PTCL

An Open Label, Phase II Study to Evaluate the Efficacy and Safety of Tenalisib (RP6530), Given With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) Therapy for Front Line Treatment in Patients With Peripheral T-cell Lymphoma

CR rate is defined as the percentage of patients showing complete response as assessed by the Investigator according to the Lugano Classification.

ORR is defined as sum of CR and PR rates, as assessed by the Investigator according to the Lugano Classification

The duration of response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.

PFS is defined as the duration of time from start of treatment to time of documentation of progression or death from any cause

OS is defined as the duration of time from start of treatment to death from any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of Tenalisib (RP6530) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)	NCT04204057	Leukemia, Lymph...	Tenalisib	18 Years -	Rhizen Pharmaceuticals SA
Safety and Efficacy Study of Tenalisib (RP6530) in Combination With Pembrolizumab in Relapsed or Refractory cHL	NCT03471351	Classical Hodgk...	Tenalisib Pembrolizumab	18 Years -	Rhizen Pharmaceuticals SA
Efficacy and Safety of Tenalisib (RP6530) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)	NCT04204057	Leukemia, Lymph...	Tenalisib	18 Years -	Rhizen Pharmaceuticals SA
Compassionate Use Study of Tenalisib (RP6530)	NCT03711604	Hematological M...	Tenalisib	18 Years -	Rhizen Pharmaceuticals SA
Efficacy and Safety of Tenalisib (RP6530), a PI3K δ/γ and SIK3 Inhibitor, in Patients With Locally Advanced or Metastatic Breast Cancer	NCT05021900	Locally Advance... Metastatic Brea...	Tenalisib Tenalisib	18 Years -	Rhizen Pharmaceuticals SA
Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC)	NCT06189209	Triple Negative...	Tenalisib	18 Years -	Rhizen Pharmaceuticals SA
Safety and Efficacy Study of Tenalisib (RP6530) in Combination With Pembrolizumab in Relapsed or Refractory cHL	NCT03471351	Classical Hodgk...	Tenalisib Pembrolizumab	18 Years -	Rhizen Pharmaceuticals SA
Compassionate Use Study of Tenalisib (RP6530)	NCT03711604	Hematological M...	Tenalisib	18 Years -	Rhizen Pharmaceuticals SA
Efficacy and Safety Study of Tenalisib (RP6530), a Novel PI3K δ/γ Dual Inhibitor in Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (iNHL)	NCT03711578	Non Hodgkin Lym...	Tenalisib,	18 Years -	Rhizen Pharmaceuticals SA
Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma	NCT03770000	T Cell Lymphoma	Tenalisib Romidepsin	18 Years -	Rhizen Pharmaceuticals SA
Study to Evaluate the Efficacy and Safety of Tenalisib, Given With CHOP Therapy for Front Line Treatment in Patients With PTCL	NCT05239910	Peripheral T Ce...	Tenalisib	18 Years -	Rhizen Pharmaceuticals SA
Compassionate Use Study of Tenalisib (RP6530)	NCT03711604	Hematological M...	Tenalisib	18 Years -	Rhizen Pharmaceuticals SA

Spots Global Cancer Trial Database for tenalisib

Every month we try and update this database with for tenalisib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tenalisib

Every month we try and update this database with for tenalisib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tenalisib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.