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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

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ClinicalTrials.gov Identifier: NCT05021900
Recruitment Status : Recruiting
First Posted : August 26, 2021
Last Update Posted : November 2, 2021
Sponsor:
Information provided by (Responsible Party):
Rhizen Pharmaceuticals SA

Tracking Information
First Submitted Date  ICMJE August 19, 2021
First Posted Date  ICMJE August 26, 2021
Last Update Posted Date November 2, 2021
Actual Study Start Date  ICMJE October 13, 2021
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2021)
Percentage of patients without disease progression [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2021)
  • Overall Response Rate (ORR) [ Time Frame: 2 years ]
    It is defined as sum of CR and PR rates
  • Clinical Benefit Rate (CBR) [ Time Frame: 2 years ]
    It is defined as sum of CR, PR and SD rates
  • 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.
  • Treatment emergent adverse events (TEAEs) [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Tenalisib (RP6530), a PI3K δ/γ and SIK3 Inhibitor, in Patients With Locally Advanced or Metastatic Breast Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Locally Advanced Breast Cancer
  • Metastatic Breast Cancer
Intervention  ICMJE
  • Drug: Tenalisib
    Tenalisib will be administered 800mg BID, orally
  • Drug: Tenalisib
    Tenalisib will be administered 1200mg BID, orally
Study Arms  ICMJE
  • Experimental: Tenalisib 800 mg BID
    Intervention: Drug: Tenalisib
  • Experimental: Tenalisib 1200 mg BID
    Intervention: Drug: Tenalisib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 19, 2021)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Prajak Barde +41325800175 pjb@rhizen.com
Listed Location Countries  ICMJE Georgia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05021900
Other Study ID Numbers  ICMJE RP6530-2101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rhizen Pharmaceuticals SA
Study Sponsor  ICMJE Rhizen Pharmaceuticals SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rhizen Pharmaceuticals SA
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP