Clinical trial • Phase II • Oncology

Atorvastatin for Metastatic breast cancer | Metastatic ovarian cancer | Metastatic prostate cancer | Metastatic kidney cancer

Phase II trial of Atorvastatin for Metastatic breast cancer | Metastatic ovarian cancer | Metastatic prostate cancer | Metastatic kidney cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic breast cancer | Metastatic ovarian cancer | Metastatic prostate cancer | Metastatic kidney cancer
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
06-08-2024
First CTIS Authorization Date
20-08-2024

Trial design

Supervised group exercise versus self-administered exercise; atorvastatin (Lipistad 40 mg film-coated tablet) combined with supervised group exercise versus no atorvastatin (dose/schedule not specified in CTIS record).-controlled Phase II trial across 1 site in Finland.

Comparator
Supervised group exercise versus self-administered exercise; atorvastatin (Lipistad 40 mg film-coated tablet) combined with supervised group exercise versus no atorvastatin (dose/schedule not specified in CTIS record).
Target Sample Size
240

Eligibility

Recruits 240 Minors and pregnant or breastfeeding women are explicitly listed as a special category of subjects to be excluded: "Special category of subjects under the Medical Research Act (1999/488) (e.g. minors and pregnant or breastfeeding women)." Participants must be adults (18 years or older) and must provide written informed consent. Subject information and informed consent forms are available (documents listed: L1_SIS and ICF finnish Redacted; L1:SIS and ICF english Redacted; L1_SIS and ICF swedish Redacted)..

Pregnancy Exclusion
Special category of subjects under the Medical Research Act (1999/488) (e.g. minors and pregnant or breastfeeding women).
Vulnerable Population
Minors and pregnant or breastfeeding women are explicitly listed as a special category of subjects to be excluded: "Special category of subjects under the Medical Research Act (1999/488) (e.g. minors and pregnant or breastfeeding women)." Participants must be adults (18 years or older) and must provide written informed consent. Subject information and informed consent forms are available (documents listed: L1_SIS and ICF finnish Redacted; L1:SIS and ICF english Redacted; L1_SIS and ICF swedish Redacted).

Inclusion criteria

  • {"criterion_text":"- 1) Patients with histologically and imaging confirmed metastatic prostate, breast, ovarian or renal cancer for which 1st line anticancer therapy is being initiated.\n- 2) The patient consents to the study and signs a written informed consent.\n- 3) Women (breast, ovarian and renal cancer) and men (prostate and renal cancer) of legal age (18 years =>) are recruited.\n- 4) Women will use a reliable method of contraception during the trial."}

Exclusion criteria

  • {"criterion_text":"- All patients: 1. High fracture risk\n- 2. Unable to exercise and/or unable to receive anticancer therapy\n- 3. Psychologically uncooperative\n- 4. Severe liver or kidney failure\n- 5. Special category of subjects under the Medical Research Act (1999/488) (e.g. minors and pregnant or breastfeeding women).\n- In addition to excl. criteria for patients who were not on statin medication at the start of the study: Active use of cholesterol-lowering drugs\n- A history of serious side effects from cholesterol-lowering drugs\n- Continued use of drugs that interact with atorvastatin during the period of the study"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Cancer progression (based on radiological, biochemical or clinical evaluation) and mortality (evaluated by time from starting 1. line cancer treatment to death)","definition_or_measurement_approach":"Cancer progression: based on radiological, biochemical or clinical evaluation. Mortality: evaluated by time from starting 1st line cancer treatment to death."}

Recruitment

Planned Sample Size
240
Recruitment Window Months
116
Consent Approach
Participants (adults, 18 years or older) must provide written informed consent; the CTIS record lists subject information and informed consent form documents in Finnish, English and Swedish (L1_SIS and ICF finnish Redacted; L1:SIS and ICF english Redacted; L1_SIS and ICF swedish Redacted). No assent process for minors is described as minors are excluded.

Geography

Total Number Of Sites
1
Total Number Of Participants
240

Finland

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
02-03-2026
Processing Time Days
615
Number Of Sites
1
Number Of Participants
240

Sites

Site Name
Pirkanmaan hyvinvointialue
Department Name
Urology department
Principal Investigator Name
Teemu Murtola
Principal Investigator Email
teemu.murtola@pirha.fi
Contact Person Name
Teemu Murtola
Contact Person Email
teemu.murtola@pirha.fi
Number Of Participants
240

Sponsor

Primary sponsor

Full Name
Pirkanmaan hyvinvointialue
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Finland

Investigational products

Investigational Product Name
Lipistad 40 mg kalvopäällysteiset tabletit
Active Substance
Atorvastatin
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Marketing authorisation present (marketingAuthNumber 32734, authorisation country FI)
Maximum Dose
40 mg
Combination Treatment
Yes

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