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Study of Radspherin® in Recurrent Ovarian Cancer Subjects With Peritoneal Carcinomatosis

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ClinicalTrials.gov Identifier: NCT03732768
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : January 19, 2023
Information provided by (Responsible Party):
Oncoinvent AS

Brief Summary:

RAD-18-001 is a First-In-Man, Dose Escalation study conducted at 2 sites. The dose escalation will be performed based on a 3 + 3 design. Increasing dose levels starting at 1 MBq will be followed by 2, 4 and 7 MBq. If the highest dose level of 7 MBq is reached without Dose Limiting Toxicicities (which will stop the dose escalation), this will be the recommended dose for further exploration. Each subject will be followed until disease progression (in the abdominal cavity), or for 24 months after the administration of Radspherin® (whichever comes first).

In the expansion cohort the subject will receive the recommended dose. The expansion cohort will be conducted at 4 sites. Each subject will be followed until disease progression (in the abdominal cavity), or for 24 months after the administration of Radspherin® (whichever comes first).

Condition or disease Intervention/treatment Phase
Peritoneal Carcinomatosis Ovarian Cancer Drug: Radspherin Phase 1

Detailed Description:

The maximum number of subjects enrolled in this study is 49.

The following number of subjects will be recruited in the different cohorts:

  • Dose escalation cohorts: 3 - 24 Subjects
  • Expansion cohort: Up to 25 Subjects

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 3+3 dose escalation study followed by an expansion cohort.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 1 Study to Evaluate the Dose, Safety and Tolerability of an Intraperitoneal α-emitting Radionuclide Therapy (Radspherin®) in Patients With Platinum Sensitive Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma With Peritoneal Carcinomatosis Following CRS
Actual Study Start Date : June 8, 2020
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: Radspherin Drug: Radspherin
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. The Sponsor will provide Radspherin® in single dose glass vial and the dose for each subject will be prepared at the site.

Primary Outcome Measures :
  1. Number of participants with Dose Limiting Toxicities as assessed by CTCAE v5.0. [ Time Frame: 24 months ]
    To investigate safety and toxicity of Radspherin®

  2. Maximum Tolerated Dose (MTD) [ Time Frame: 21 days ]
    To determine the MTD of Radspherin®, among the four suggested doses 1, 2, 4 and 7 MBq, as a single intraperitoneal (IP) injection and two repeated IP injections following cytoreductive surgery (CRS)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. Able and willing to provide written informed consent and to comply with the clinical study protocol
  2. Age ≥ 18 years
  3. Histologically confirmed epithelial ovarian, fallopian tube and primary peritoneal carcinoma
  4. Platinum sensitive recurrences of ovarian carcinoma who are eligible for debulking surgery to R0.
  5. AEs recovered to at least grade 1 from the effects (excluding alopecia) of any prior medical therapy for malignancy at time of first administration of Radspherin®
  6. ECOG Performance Status Score of 0 - 1
  7. Adequate renal function

    • Creatinine ≤ 1.8 mg/dl (159 μmol/l) and
    • calculated creatinine clearance using the Cockcroft-Gault formula ≥ 45 ml/min, or
    • measured creatinine clearance ≥ 45 ml/min
  8. Adequate hepatic function

    • Serum bilirubin <1.5 x upper limit of normal (ULN)
    • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN
  9. Adequate bone marrow function:

    • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/l
    • Platelets ≥ 100 x 10^9/l
    • Haemoglobin ≥ 9 g/dL
  10. Adequate coagulation tests: INR ≤ 1.5 x ULN
  11. For females of childbearing potential, a negative pregnancy test must be documented prior to enrolment
  12. For females of childbearing potential who have a male partner: agreement to use two adequate methods of contraception (e.g. barrier, intrauterine device, hormonal implants, combined oral contraceptives or vasectomized partner), during the treatment period and for at least 3 months after the last dose of IMP.

Exclusion Criteria:

  1. Neuroendocrine tumors, or non-epithelial ovarian cancers (e.g. germ cell tumors, Sex-cord tumors)
  2. Tumors of borderline malignancy
  3. Other synchronous visceral metastatic lesions, symptomatic CNS metastases. Metastatic lymph nodes are acceptable, except thoracic lymph nodes.
  4. Pregnant or lactating (nursing) women
  5. Active infections requiring antibiotics, and/or physician monitoring or recurrent fever >38.0 ⁰C associated with a clinical diagnosis of active infection
  6. Active liver disease with positive serology for active hepatitis B, hepatitis C or known HIV
  7. Administration of an investigational medicinal product within 28 days, or at least 5 times the half-life, prior to enrolment
  8. Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to, and up to 4 weeks after the last study treatment
  9. Another primary malignancy within the past 3 years (except for non-melanoma skin cancer, cervical cancer in situ or in situ stage 1 synchronous endometrial cancer)
  10. Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease
  11. Any condition or illness that, in the opinion of the Investigator or the medical monitor, would compromise the safety of the subjects or interfere with the evaluation of the safety of the IMP
  12. 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
  13. Treatment with bevacizumab (Avastin®) within 5 weeks prior to CRS
  14. Known hypersensitivity to any of the excipients in the study drug
  15. Persons who have been placed in an institution under an official or judicial order
  16. Persons who are dependent on the sponsor financially must be excluded from participation
  17. Persons with active SARS-CoV-2 infection must be excluded from participation

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): NCT03732768

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Contact: Anne-Kirsti Aksnes, PhD +47 22 18 33 05 aksnes@oncoinvent.com
Contact: Trine J Gjertsen +47 22 18 33 05 gjertsen@oncoinvent.com

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UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Els Van Nieuwenhuysen, MD         
The Norwegian Radiumhospital Recruiting
Oslo, Norway
Contact: Yun Wang, MD         
Clínica Universidad de Navarra Recruiting
Madrid, Spain
Contact: Luis M Chiva, MD, PhD         
Clínica Universidad de Navarra Recruiting
Pamplona, Spain
Contact: Luis M Chiva, MD, PhD         
Sponsors and Collaborators
Oncoinvent AS
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Responsible Party: Oncoinvent AS
ClinicalTrials.gov Identifier: NCT03732768    
Other Study ID Numbers: RAD-18-001
2018-002802-29 ( EudraCT Number )
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: January 19, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases