ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03732768
Recruitment Status : Not yet recruiting
First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Oncoinvent AS

Brief Summary:
RAD-18-001 is a First-In-Man, Dose Escaltion 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. Acceptability of up to 7 MBq gives the opportunity to explore the doses of the dose escalation split into two administrations, and given as two separate injections 1 week apart. Split doses of 1, 2 and 3.5 MBq will be administered as two injections. Each subject will be followed until disease progression (in the abdominal cavity), or for 12 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 39.

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

  • Dose escalation cohorts (Phase 1a): 3 - 24 Subjects
  • Repeated injection cohorts (Phase 1b): 3 - 9 Subjects
  • Expansion cohort: 6 Subjects

Study Type : Interventional
Estimated Enrollment : 39 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 3+3 dose escalation study
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 Complete Surgical Resection
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : June 2022

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. Maximum Tolerated Dose [ Time Frame: 21 days ]


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.


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
Criteria

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 109/l
    • Platelets ≥ 100 x 109/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
  8. Concurrent administration of any cancer therapy other than planned study treatment 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

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


Contacts
Contact: Helen J Blanco, MSc +4747632029 blanco@oncoinvent.com
Contact: Øyvind S Bruland, MD PhD +4797174004 osb@ous-hf.no

Locations
Belgium
UZ Leuven Not yet recruiting
Leuven, Belgium, 3000
Contact: Ignace Vergote, MD    +32 16346900    ignace.vergote@uzleuven.be   
Norway
The Norwegian Radiumhospital Not yet recruiting
Oslo, Norway
Contact: Yun Wang, MD    +47 22934771    yun.wang@ous-hf.no   
Sponsors and Collaborators
Oncoinvent AS
Investigators
Study Director: Helen J Blanco, MSc Oncoinvent AS

Responsible Party: Oncoinvent AS
ClinicalTrials.gov Identifier: NCT03732768     History of Changes
Other Study ID Numbers: RAD-18-001
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Ovarian Neoplasms
Carcinoma
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type