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| Name | Class |
|---|---|
| Incozen Therapeutics Pvt Ltd | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm, Open label study | Experimental | Single agent Tenalisib [RP6530 (PI3k delta, gamma and SIK3 inhibitor)] |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenalisib | Drug | Tenalisib will be administered 800mg/ 400mg BID, orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit Rate (CBR) | It is defined as the percentage of patients achieving complete response (CR), partial response (PR), or stable disease (SD) for 16 weeks or longer. | 1 year |
| Duration of Clinical Benefit (DoCB) | 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. | 1 year |
| Overall Response Rate (ORR) | Overall Response is defined as sum of CR and PR. | 1 year |
| Progression Free Survival (PFS) | It is defined as the time from the first dose to disease progression or death on study from any cause, whichever occurs first. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0 | Number of adverse events reported by the patients | 1 year |
| Trough plasma concentrations of tenalisib/metabolite |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prajak Barde, MD | Contact | +41325800175 | pjb@rhizen.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HCG City Cancer Center | Recruiting | Vijayawada | Andhra Pradesh | 520002 | India |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| C000706530 | tenalisib |
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plasma concentrations of drug
| 1 year |
| Correlation of efficacy to baseline mutational status | Baseline mutational status and its correlation with efficacy | 1 year |
| Narayana Hrudayala Majumdar Shaw Hospital | Recruiting | Bangalore | Karnataka | 560099 | India |
|
| Tata Memorial Centre | Recruiting | Mumbai | Maharashtra | 400012 | India |
|
| Mumbai Oncocare Centre | Recruiting | Mumbai | Maharashtra | 400056 | India |
|
| Sahyadri Super Speciality Hospital | Recruiting | Pune | Maharashtra | 411004 | India |
|
| Nobel Hospital | Recruiting | Pune | Maharashtra | 411013 | India |
|
| Meenakshi Mission Hospital & Research Center | Not yet recruiting | Madurai | Tamil Nadu | 625107 | India |
|
| Nizams Institute of Medical Science | Not yet recruiting | Hyderabad | Telangana | 500082 | India |
|
| Health Point Hospital | Recruiting | Kolkata | West Bengal | 700025 | India |
|
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |