AzTrials
AzTrials

Ovarian Neoplasm EpithelialPhase 2NCT03509246

Bortezomib and Pegylated Liposomal Doxorubicin in BRCA Wild-type Platinum-resistant Recurrent Ovarian Cancer Patients

A Phase 2 study testing Pegylated liposomal doxorubicin plus Bortezomib in people with Ovarian Neoplasm Epithelial and High Grade Serous Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study is a phase II clinical trial to evaluate the safety and efficacy of Bortezomib plus Pegylated liposomal doxorubicin combination therapy in a histologic type of high-grade serous carcinoma without BRCA mutation among patients with platinum-resistant recurrent ovarian cancer. Read more about this study

Who is it for?
Ages 19 years and older, women only
What is being tested?
Pegylated liposomal doxorubicin plus Bortezomib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteSouth Korea
Study dates
15 May 2018to Mar 2022
Phase
Phase 2
Are there results?
None posted in the registry

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 19 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients diagnosed with epithelial ovarian cancer, fallopian tube cancer, or peritoneal cancer based on histologic findings obtained from biopsy/surgery and having a histologic type of high-grade serous cancer.
  • In the absence of a mutation of the BRCA gene (no germline mutation should be identified, not in the case of a somatic mutation)
  • Recurrence within 6 months after platinum-based chemotherapy.
  • ECOG performance 2 points or less.
  • Blood tests performed within 2 weeks of enrollment meet the following results: Neutrophil > 1,500/mm3; Platelet > 100,000/mm3; Hemoglobin > 9.0 g/dL; Total bilirubin < 1.5 x upper limit of normal (ULN); AST/ALT < 3.0 x ULN (or < 5 x ULM in case of liver metastases); Creatinine < 1.5 x ULN; Electrolytes should be within normal limits.
  • Patients who understand the content of the study description and voluntarily agree in writing.
  • Patients who are willing and able to adhere to the visit schedule, treatment plan, laboratory tests, and other testing procedures.

Who cannot join

  • Patients previously treated with three or more anticancer regimens. Maintenance therapy is not considered a separate regimen (eg> paclitaxel-carboplatin-bevacizumab therapy). In the combined chemotherapy, when one drug is subtracted due to toxicity, the regimen is not counted as a change (Eg> paclitaxel-carboplatin chemotherapy, paclitaxel was discontinued due to neurotoxicity and carboplatin alone was not considered as a change of regimen).
  • Previous refractory to ovarian cancer chemotherapy.
  • Patients diagnosed with other tumors other than ovarian cancer for the last 5 years (not CIS).
  • pregnant woman.
  • Patients with uncontrolled infection.
  • In the case of congenital immune disease or acquired immune deficiency syndrome.
Show all 12Show fewer
  • Women in lactation.
  • History with Grade 3 or higher peripheral neuropathy.
  • History of hypersensitivity reactions to PLD or bortezomib.
  • If the physician is judged to have any serious illness or medical condition for which the patient is not suitable for the study.
  • Patients with confirmed BRCA somatic mutations.
  • Patients with acute diffuse infiltrative lung disease and cardiovascular disease.

Trial locations and contacts

1 site in 1 country.

Kidong Kim contact

82-31-787-7262

kidong.kim.md@gmail.com

South Korea1 site, 1 recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyenggi DO, 463707

    KIDONG KIM, MD, 82-31-787-7262, KIDONG.KIM.MD@GMAIL.COM

    KIDONG KIM, MD

    Recruiting

Other trials in South Korea

About this study

Official title: A Phase II Trial to Evaluate the Efficacy of Bortezomib and Pegylated Liposomal Doxorubicin in Patients With BRCA Wild-type Platinum-resistant Recurrent Ovarian Cancer

This study is a phase II clinical trial to evaluate the safety and efficacy of Bortezomib plus Pegylated liposomal doxorubicin combination therapy in a histologic type of high-grade serous carcinoma without BRCA mutation among patients with platinum-resistant recurrent ovarian cancer.

Read the detailed description

Subjects are dosed with Bortezomib and PLD for a maximum of 6 cycles of 4 weeks. The response rate is evaluated with CT according to RECIST criteria ver 1.1. The efficacy and safety of the drug are assessed at the time of recurrence, at the time of death, or after 24 months after the end of the study drug administration.

Being tested
Pegylated liposomal doxorubicin plus Bortezomib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pegylated liposomal doxorubicin plus BortezomibDrug

    Pegylated liposomal doxorubicin 40mg/m2 subcutaneous for 60 - 90 minutes at day 4 plus Bortezomib 1.3mg/m2 subcutaneous injection at day 1,4,8,11 for 6 cycles

Study groups in NCT03509246
Study groupRoleWhat they receive
Pegylated liposomal doxorubicin plus Bortezomib combinationExperimentalAt BRCA wild-type platinum-resistant recurrent ovarian cancer patients, Pegylated liposomal doxorubicin and Bortezomib combination therapy for six cycles.
Receives: Drug: Pegylated liposomal doxorubicin plus Bortezomib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

    In the modified ITT group, the response rate to combination therapy with bortezomib and PLD 2

    Measured: up to 6yr

  2. Partial response rate

    The percentage of patients who received a confirmed treatment response over a partial response according to the RECIST criteria version 1.1 in the modified ITT analysis group. The evaluation is based on the researchers of each participating organization.

    Measured: up to 6yr

Secondary outcomes (7)

  1. Complete remission rate

    The proportion of subjects who had a confirmed complete response according to RECIST criteria version 1.1 in the modified ITT analysis group

    Measured: up to 6yr

  2. Progression-free survival

    Patients who have recurred disease after the end of the administration are identified and measured.

    Measured: up to 2yr

  3. Overall survival

    Patients who died from illness after the start of treatment were identified and measured.

    Measured: up to 6yr

  4. Response period

    duration of objective response period

    Measured: up to 5yr

  5. Quality of life

    Evaluation via Physicians Global Assessment to measure the quality of life and pain descriptive diary.

    Measured: up to 6yr

  6. Adverse drug reactions

    To be evaluated according to NCI CTCAE version 4.03 Frequency of occurrence of each drug adverse reaction and 95% confidence interval, grade 3 or higher, the frequency of adverse drug events and 95% confidence interval.

    Measured: up to 6yr

  7. Genetic susceptibility assessment

    Response rate in subjects with CCNE1 amplification.

    Measured: up to 6yr

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2018
  2. Study start15 May 2018
  3. Primary completionMar 2022 (estimated)
  4. Study completionMar 2022 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03509246
Sponsor's protocol ID
EBLIN
Status last verified
Jan 2020
First submitted
29 Mar 2018
Last updated
14 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Orlowski RZ, Nagler A, Sonneveld P, Blade J, Hajek R, Spencer A, San Miguel J, Robak T, Dmoszynska A, Horvath N, Spicka I, Sutherland HJ, Suvorov AN, Zhuang SH, Parekh T, Xiu L, Yuan Z, Rackoff W, Harousseau JL. Randomized phase III study of pegylated liposomal doxorubicin plus bortezomib compared with bortezomib alone in relapsed or refractory multiple myeloma: combination therapy improves time to progression. J Clin Oncol. 2007 Sep 1;25(25):3892-901. doi: 10.1200/JCO.2006.10.5460. Epub 2007 Aug 6.

    PubMed 17679727

  • Etemadmoghadam D, Weir BA, Au-Yeung G, Alsop K, Mitchell G, George J; Australian Ovarian Cancer Study Group; Davis S, D'Andrea AD, Simpson K, Hahn WC, Bowtell DD. Synthetic lethality between CCNE1 amplification and loss of BRCA1. Proc Natl Acad Sci U S A. 2013 Nov 26;110(48):19489-94. doi: 10.1073/pnas.1314302110. Epub 2013 Nov 11.

    PubMed 24218601

  • Kim G, Ison G, McKee AE, Zhang H, Tang S, Gwise T, Sridhara R, Lee E, Tzou A, Philip R, Chiu HJ, Ricks TK, Palmby T, Russell AM, Ladouceur G, Pfuma E, Li H, Zhao L, Liu Q, Venugopal R, Ibrahim A, Pazdur R. FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy. Clin Cancer Res. 2015 Oct 1;21(19):4257-61. doi: 10.1158/1078-0432.CCR-15-0887. Epub 2015 Jul 17.

    PubMed 26187614

  • Cancer Genome Atlas Research Network. Integrated genomic analyses of ovarian carcinoma. Nature. 2011 Jun 29;474(7353):609-15. doi: 10.1038/nature10166.

    PubMed 21720365

  • Lee YJ, Seol A, Lee M, Kim JW, Kim HS, Kim K, Suh DH, Kim S, Kim SW, Lee JY. A Phase II Trial to Evaluate the Efficacy of Bortezomib and Liposomal Doxorubicin in Patients With BRCA Wild-type Platinum-resistant Recurrent Ovarian Cancer (KGOG 3044/EBLIN). In Vivo. 2022 Jul-Aug;36(4):1949-1958. doi: 10.21873/invivo.12917.

    PubMed 35738633

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pegylated liposomal doxorubicin plus Bortezomib in people with Ovarian Neoplasm Epithelial and High Grade Serous Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.

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 12 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: status not confirmed, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kidong Kim (82-31-787-7262, kidong.kim.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: up to 6yr). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03509246, which also lists 5 linked publications.

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 14 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in