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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05021900
Recruitment Status : Active, not recruiting
First Posted : August 26, 2021
Last Update Posted : May 3, 2022
Information provided by (Responsible Party):
Rhizen Pharmaceuticals SA

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Locally Advanced Breast Cancer Metastatic Breast Cancer Drug: Tenalisib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 13, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Tenalisib 800 mg BID Drug: Tenalisib
Tenalisib will be administered 800mg BID, orally

Experimental: Tenalisib 1200 mg BID Drug: Tenalisib
Tenalisib will be administered 1200mg BID, orally

Primary Outcome Measures :
  1. Percentage of patients without disease progression [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: 2 years ]
    It is defined as sum of CR and PR rates

  2. Clinical Benefit Rate (CBR) [ Time Frame: 2 years ]
    It is defined as sum of CR, PR and SD rates

  3. Progression Free Survival (PFS). [ Time Frame: 2 years ]
    PFS is measured from the time of first dose of study drug to radiographic documentation of disease progression or death due to any cause.

  4. Treatment emergent adverse events (TEAEs) [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients must be ≥18 years of age, at the time of signing informed consent.
  2. Female patients who have histologically and/or cytologically confirmed locally advanced or metastatic breast cancer that has progressed following at least one line of therapy.
  3. Patients with at least one measurable lesion per RECIST version 1.1 at baseline that can be accurately assessed by CT scan or MRI and is suitable for repeated assessment at follow up-visits.
  4. ECOG performance status 0 to 2.
  5. Life expectancy of at least 3 months.
  6. Adequate bone marrow, liver, and renal functions
  7. Female patients of childbearing potential should be willing to use a medically acceptable method of contraception

Exclusion Criteria:

  1. Patients with HER-2 positive breast cancer.
  2. Patients receiving anticancer therapy within 4 weeks or 5 half-lives of the drug prior to C1D1, whichever is shorter.
  3. Patient who has not recovered from acute toxicities (defined as NCI-CTCAE grade > 1) of previous therapy except treatment-related alopecia.
  4. Patients who have had disease progression within 8 weeks of platinum chemotherapy.
  5. Prior exposure to investigational or marketed PI3K inhibitors given for the treatment of breast cancer.
  6. Major surgery within 4 weeks of starting study treatment OR any patient who has not recovered from the effects of major surgery.
  7. Patient with symptomatic uncontrolled brain metastasis.
  8. HIV-positive patients who are on antiretroviral therapy OR active hepatitis C OR active hepatitis B virus infections.
  9. Ongoing immunosuppressive therapy including systemic corticosteroids except as allowed per concomitant medication.
  10. Known history of severe liver injury as judged by the investigator.
  11. History of severe cutaneous reactions in the past.
  12. Active gastrointestinal tract disease with malabsorption syndrome or uncontrolled inflammatory gastrointestinal disease such as Crohn's disease or ulcerative colitis.
  13. Pregnancy or lactation.
  14. Patient with other active malignancies at the time of screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05021900

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High Technology Hospital Medcenter
Batumi, Georgia
LLC Caucasus Medical Center
Tbilisi, Georgia, 0186
Simon Khechinashvili University Hospital
Tbilisi, Georgia
Sponsors and Collaborators
Rhizen Pharmaceuticals SA
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Responsible Party: Rhizen Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT05021900    
Other Study ID Numbers: RP6530-2101
First Posted: August 26, 2021    Key Record Dates
Last Update Posted: May 3, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rhizen Pharmaceuticals SA:
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Phosphoinositide-3 Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action