Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Tenalisib

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Phosphoinositide-3 Kinase Inhibitors

Enzyme 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)

Rhizen Pharmaceuticals SA

Hematologic Neoplasms

Hematologic Diseases

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)

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

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

Overall Study

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Lymphoma, T-Cell, Cutaneous

Lymphoma, Non-Hodgkin

Peripheral T-cell Lymphoma

RP6530

Auris Huen, MD

The purpose of this study is to evaluate the safety, PK and efficacy of RP6530, a dual PI3K delta/gamma inhibitor in patients with relapsed and refractory T-cell Lymphoma.

Safety: Treatment-Emergent AE; Treatment-Related AE, SAE and Clinical significant AE; Dose Limiting Toxicities (DLT). PK: Peak Plasma Concentration (Cmax), Area under the plasma concentration versus time curve (AUC), Time of Maximum concentration observed (Tmax). Efficacy: Overall Response Rate (ORR), Progression Free Survival (PFS), Overall Survival (OS) and Duration of Response.

Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma

A Phase I/Ib, Dose Escalation Study to Evaluate Safety and Efficacy of RP6530, a Dual PI3K δ/γ Inhibitor, in Patients With Relapsed or Refractory T-cell Lymphoma

Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0

ORR is defined as sum of CR and PR rates, Response assessment for PTCL based on IWG criteria (Cheson 2007) and CTCL on mSWAT/Global assessment (ISCL/EORTC guideline).

Peak Plasma Concentration (Cmax) of RP6530

Summary of Related Treatment Emergent Adverse Events - All Patients

RP6530 administered 200 mg orally twice a day.

Dose escalation_Cohort 1_200 mg

RP6530 administered 400 mg orally twice a day.

Dose escalation_Cohort 2_400 mg

RP6530 administered 800 mg orally twice a day under fasting condition

Dose escalation_Cohort 3_800 mg (Fasting)

RP6530 administered 800 mg orally twice a day under fed condition

Dose escalation_Cohort 4_800 mg (Fed)

Dose expansion_PTCL_800 mg (Fasting)

Dose expansion_CTCL_800 mg (Fasting)

Total

United States

Region of Enrollment

Prajak Barde MD

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) treatment with Tenalisib and is considered related to Tenalisib.

Safety of RP6530

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 RP6530

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 RP6530

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

Peak Plasma Concentration (Cmax)

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, B-Cell

B-cell Lymphoma

Andrés JM Ferreri, MD

Carmelo Carlo-stella, MD

Richard Delarue, MD

The objective of this study is to evaluate the safety and efficacy of RP6530, a dual PI3K delta/gamma inhibitor in patients with hematologic malignancies.

The Maximum tolerated dose (MTD) will be determined based on the safety, pharmacokinetic (PK) and efficacy data. Safety analyses include AE's, AE's related to the drug, SAE's, laboratory values, vitals/ ECG and dose limiting toxicity (DLT). PK include measurement of peak plasma concentration (Cmax), area under the plasma concentration versus the time curve (AUC), time of maximum concentration observed (Tmax). Efficacy analyses include overall response rate (ORR) and duration of response (DOR).

Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in Hematological Malignancies

A Phase I, Dose Escalation Study to Evaluate Safety and Efficacy of RP6530, a Dual PI3K Delta/Gamma Inhibitor, in Patients With Relapsed or Refractory Hematologic Malignancies

* To access maximum tolerated dose by clinical laboratory assessments, adverse events and dose limiting toxicities.
* PK parameter AUC, Cmax, tmax, t1/2 will be determined.

Overall response rate (ORR) and duration of response (DOR).

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

Age, Categorical

Australia

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

Objective Response Rate (ORR)

Complete Response Rate

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

Progression Free Survival (PFS)

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 v4.0

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)

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)

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) 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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma	NCT02567656	Lymphoma, T-Cel... Lymphoma, T-Cel...	RP6530	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
Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in Hematological Malignancies	NCT02017613	Lymphoma, B-Cel... T-Cell Lymphoma	RP6530	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 rp6530

Every month we try and update this database with for rp6530 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 rp6530

Every month we try and update this database with for rp6530 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 rp6530 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.