Locally Advanced Breast CancerPhase 2NCT05021900
Efficacy and Safety of Tenalisib (RP6530), in Patients With Locally Advanced or Metastatic Breast Cancer
A Phase 2 study testing Tenalisib 800mg and Tenalisib 1200mg in people with Locally Advanced Breast Cancer and Metastatic Breast Cancer, run by Rhizen Pharmaceuticals SA at 3 sites in Georgia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Advanced Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- Tenalisib 800mg and Tenalisib 1200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesGeorgia
- Study dates
- 13 Oct 2021to 31 Mar 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be ≥18 years of age, at the time of signing informed consent.
- 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.
- 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.
- ECOG performance status 0 to 2.
- Life expectancy of at least 3 months.
- Adequate bone marrow, liver, and renal functions
- Female patients of childbearing potential should be willing to use a medically acceptable method of contraception
Who cannot join
- Patients with HER-2 positive breast cancer.
- Patients receiving anticancer therapy within 4 weeks or 5 half-lives of the drug prior to C1D1, whichever is shorter.
- Patient who has not recovered from acute toxicities (defined as NCI-CTCAE grade > 1) of previous therapy except treatment-related alopecia.
- Patients who have had disease progression within 8 weeks of platinum chemotherapy.
- Prior exposure to investigational or marketed PI3K inhibitors given for the treatment of breast cancer.
- Major surgery within 4 weeks of starting study treatment OR any patient who has not recovered from the effects of major surgery.
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- Patient with symptomatic uncontrolled brain metastasis.
- HIV-positive patients who are on antiretroviral therapy OR active hepatitis C OR active hepatitis B virus infections.
- Ongoing immunosuppressive therapy including systemic corticosteroids except as allowed per concomitant medication.
- Known history of severe liver injury as judged by the investigator.
- History of severe cutaneous reactions in the past.
- Active gastrointestinal tract disease with malabsorption syndrome or uncontrolled inflammatory gastrointestinal disease such as Crohn's disease or ulcerative colitis.
- Pregnancy or lactation.
- Patient with other active malignancies at the time of screening.
Trial locations and contacts
3 sites in 1 country.
Georgia3 sites
High Technology Hospital Medcenter
Batumi
LLC Caucasus Medical Center
Tbilisi, 0186
Simon Khechinashvili University Hospital
Tbilisi
About this study
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
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.
Read the detailed description
The study will have two groups, Group 1 with a treatment option of 800mg RP6530 BID and Group 2 with a treatment option of 1200mg RP6530 BID, where the subjects will be randomly assigned to each group in 1:1 and continued on each group of treatment till disease progressed.
- Being tested
- Tenalisib 800mg, Tenalisib 1200mg
- Keywords
- RP6530, Tenalisib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenalisib 800mgDrug
Also called RP6530
Tenalisib will be administered 800mg BID, orally
Tenalisib 1200mgDrug
Also called RP6530
Tenalisib will be administered 1200mg BID, orally
| Study group | Role | What they receive |
|---|---|---|
| Tenalisib 800 mg BID | Experimental | Single agent at a dose of 800 mg BID Receives: Drug: Tenalisib 800mg |
| Tenalisib 1200 mg BID | Experimental | Single agent at a dose of 1200 mg BID Receives: Drug: Tenalisib 1200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Without Disease Progression
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Approximately 6 months
Secondary outcomes (4)
Overall Response Rate (ORR)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: Approximately 18 months
Clinical Benefit Rate (CBR)
It is defined as sum of CR, PR and SD rates
Measured: Approximately 18 months
Progression Free Survival (PFS).
PFS is measured from the time of first dose of study drug to radiographic documentation of disease progression or death due to any cause.
Measured: Approximately 18 months
Treatment Emergent Adverse Events (TEAEs)
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. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product.
Measured: Approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start13 Oct 2021
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Locally Advanced Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhizen Pharmaceuticals SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021900
- Sponsor's protocol ID
- RP6530-2101
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2021
- Last updated
- 13 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05021900
- Acronym / sponsor ID
- RP6530-2101
- Keywords
- RP6530, Tenalisib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rhizen Pharmaceuticals SAIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Posted 13 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
The study will have two groups, Group 1 with a treatment option of 800mg RP6530 BID and Group 2 with a treatment option of 1200mg RP6530 BID, where the subjects will be randomly assigned to each group in 1:1 and continued on each group of treatment till disease progressed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenalisib 800 mg BID | Experimental | Drug: Tenalisib 800mgSingle agent at a dose of 800 mg BID |
| Tenalisib 1200 mg BID | Experimental | Drug: Tenalisib 1200mgSingle agent at a dose of 1200 mg BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must be ≥18 years of age, at the time of signing informed consent.
- 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.
- 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.
- ECOG performance status 0 to 2.
- Life expectancy of at least 3 months.
Key exclusion criteria (14 listed)
- Patients with HER-2 positive breast cancer.
- Patients receiving anticancer therapy within 4 weeks or 5 half-lives of the drug prior to C1D1, whichever is shorter.
- Patient who has not recovered from acute toxicities (defined as NCI-CTCAE grade > 1) of previous therapy except treatment-related alopecia.
- Patients who have had disease progression within 8 weeks of platinum chemotherapy.
- Prior exposure to investigational or marketed PI3K inhibitors given for the treatment of breast cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenalisib 800mgAlso: RP6530Tenalisib will be administered 800mg BID, orally | Drug | Tenalisib 800 mg BID |
| Tenalisib 1200mgAlso: RP6530Tenalisib will be administered 1200mg BID, orally | Drug | Tenalisib 1200 mg BID |
Primary outcome
Percentage of Patients Without Disease Progression
Time frame: Approximately 6 months
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
4 secondary outcomes
Overall Response Rate (ORR)
Time frame: Approximately 18 months
Clinical Benefit Rate (CBR)
Time frame: Approximately 18 months
Progression Free Survival (PFS).
Time frame: Approximately 18 months
Treatment Emergent Adverse Events (TEAEs)
Time frame: Approximately 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tenalisib 800mg and Tenalisib 1200mg in people with Locally Advanced Breast Cancer and Metastatic Breast Cancer, run by Rhizen Pharmaceuticals SA at 3 sites in Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Without Disease Progression (time frame: Approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.