Trial Title:
A Study of Radspherin® in Patients with Primary Advanced Epithelial Cancer, with Peritoneal Metastasis That Are Homologous Recombination Proficient Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery
NCT ID:
NCT06504147
Condition:
Peritoneal Carcinomatosis
Ovarian Cancer
Conditions: Official terms:
Carcinoma
Peritoneal Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Radspherin
Description:
Radspherin® suspension consists of bio-degradable calcium carbonate micro particles with
the α-emitting radionuclide 224Ra in suspension. 224Ra has a physical half-life of 3.6
days.
Arm group label:
Radspherin
Summary:
This is a Phase 2, controlled, randomised, parallel assignment, open label, multicentre
study to evaluate efficacy and safety of a single intraperitoneal injection of
Radspherin® in patients with primary advanced high-grade serous or high-grade
endometrioid epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer,
with peritoneal metastasis that are HR proficient and scheduled to undergo NACT and IDS.
The study will be conducted in 2 parts; first, a Safety Lead-in Cohort will be recruited
followed by the randomised part of the study. For both parts of the study, patients must
be scheduled to undergo NACT and IDS and complete resection to no residual tumour (R0)
should be deemed to be achievable during diagnostic work-up. Patients in both parts of
the study will undergo the same procedures and assessments.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Able and willing to provide written informed consent and to comply with the clinical
study protocol (CSP).
2. Female of age ≥ 18 years.
3. Patients with primary advanced high-grade serous or high-grade endometrioid
epithelial ovarian, fallopian tube, or primary peritoneal cancer (FIGO Stage IIIB/C
or IV).
4. Peritoneal and other metastases eligible for IDS to no residual tumour.
5. Adverse events recovered to at least Grade 1 from the effects (excluding alopecia)
of any prior medical therapy for malignancy.
6. Confirmed HR proficient by Myriad MyChoice CDx testing.
7. Completed 3 or 4 cycles of NACT with regress or stable disease on diagnostic imaging
and assessed to be operable to R0.
8. Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 to 2 and
patient fit enough to undergo IDS and further treatment according to standard of
care.
9. Adequate renal function:
• Calculated creatinine clearance using the Cockcroft-Gault formula ≥ 40 ml/min or
measured creatinine clearance ≥ 40 ml/min.
10. Adequate hepatic function:
- Serum bilirubin < 1.5 x upper limit of normal (ULN), and
- Aspartate transaminase and alanine transaminase ≤ 3 x ULN.
11. Adequate bone marrow function:
- Absolute neutrophil count ≥ 1.0 x 10^9/l, and
- Platelets ≥ 100 x 10^9/l, and
- Haemoglobin ≥ 9 g/dL.
12. For females of childbearing potential, a negative pregnancy test must be documented
prior to enrolment.
13. For females of childbearing potential agreement to use at least one of the following
highly effective (failure rate < 1%) methods of contraception during the treatment
period and for at least 9 months if they receive Radspherin®, unless hysterectomy or
oophorectomy is performed during IDS.
- Total abstinence (when this is in line with the preferred and usual lifestyle
of the patient), periodic abstinence (e.g. calendar, ovulation, symptothermal,
post ovulation methods) and withdrawal are not acceptable methods of
contraception.
- Female sterilisation (have had surgical bilateral oophorectomy with or without
hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before
enrolment. In case of oophorectomy alone, only when the reproductive status of
the woman has been confirmed by follow up hormone level assessment.
- Use of oral (oestrogen and progesterone), injected or implanted hormonal
methods of contraception or placement of an intrauterine device or intrauterine
system, or other forms of hormonal contraception that have comparable efficacy
(failure rate < 1%), for example hormone vaginal ring or transdermal hormone
contraception. In case of use of oral contraception women should have been
stable on the same pill for a minimum of 3 months before taking study
treatment.
Note: In addition to the use of one highly effective method of contraception as listed
above, a condom is required for all male partners during the treatment period and for at
least 9 months after the dose of IMP, unless vasectomised at least 6 months prior to
enrolment.
Exclusion Criteria:
1. Known somatic or germline BRCA1 or BRCA2 mutations or confirmed HR deficient.
2. Suspicion of peritoneal leak, shunt, or otherwise suspected atypical target
compartment pharmacokinetics, based on investigator's judgement, patient history and
diagnostic images.
3. Epithelial borderline tumours, ovarian clear cell carcinoma, mucinous ovarian
carcinoma, malignant Brenner tumours, non-epithelial ovarian malignancies,
carcinosarcoma and neuroendocrine tumours or recurrent ovarian cancer.
4. Symptomatic central nervous system metastasis.
5. Another primary malignancy within the past 3 years (except for non melanoma skin
cancer, cutaneous melanoma stage 1, cervical cancer in situ or FIGO 2023 Stage IA1
or IA3 prior or synchronous endometrial cancer).
6. Prior abdominal/pelvic radiotherapy.
7. Disease progression during 3 to 4 cycles of NACT.
8. Pregnant or lactating (nursing) women.
9. Active infections requiring antibiotics, and/or physician monitoring, or recurrent
fever > 38.0⁰C associated with a clinical diagnosis of active infection.
10. Active liver disease with positive serology for active hepatitis B, hepatitis C or
known human immunodeficiency virus (HIV).
11. Concurrent congestive heart failure or prior history of New York Heart Association
(NYHA) class III/IV cardiac disease.
12. Any condition or illness that, in the opinion of the investigator or the medical
monitor, would compromise the safety of the patients or interfere with the
evaluation of the safety of the investigational medicinal product.
13. In the investigator's opinion not able to comply with study procedures. Any medical
or psychological condition that would preclude participation in the study or
compromise the ability to give informed consent.
14. Administration of an investigational medicinal product within 4 weeks, or at least 5
times the half life, prior to enrolment.
15. Concurrent administration of any cancer therapy other than planned study treatment
within 4 weeks prior to, and up to 4 weeks after the surgery.
16. Treatment with bevacizumab within 5 weeks prior to IDS.
17. Known hypersensitivity to any of the excipients of the study drug.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hye Sook Chon, MD, PhD
Facility:
Name:
UZ Leuven
Address:
City:
Leuven
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Els Van Nieuwenhuysen, MD, PhD
Facility:
Name:
The Norwegian Radiumhospital
Address:
City:
Oslo
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Yun Wang, MD, PhD
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Luis M Chiva, MD, PhD
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Pamplona
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Luis M Chiva, MD, PhD
Facility:
Name:
Imperial College Healthcare NHS Trust
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Christina Fotopoulou, MD, PhD
Start date:
June 15, 2024
Completion date:
February 28, 2031
Lead sponsor:
Agency:
Oncoinvent AS
Agency class:
Industry
Source:
Oncoinvent AS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06504147
