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Ovarian CancerPhase 2NCT05551208

Fluzoparib Combined With Bevacizumab in PSROC Previously Treated With PARPi

A Phase 2 study testing fluzopanib and bevacizumab in people with Ovarian Cancer, run by Chongqing University Cancer Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

There are more and more PARPi(PARP inhibitors) resistance for ovarian cancer patients after previous use of PARP inhibitors. Basic studies have found that there is synergistic effect of bevacizumab combined with PARPi. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
fluzopanib and bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteChina
Study dates
15 Aug 2022to 30 Aug 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ovarian cancer patients with histopathological type: low/high grade serous carcinoma, endometrioid carcinoma,had received platinum-based regimens for at least 1-3 lines after primary cytoreductive surgery.
  • The patient had at least one measurable lesion according to the RECIST V1.1 criteria.
  • The time from the last cycle of chemotherapy to relapse/progression should be more than 6 months.
  • ECOG score 0~1,age 18~75 years old
  • The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial
  • CBC Hb≥90g/L, ANC≥1.5×109/L, PLT≥100×109/L,
  • Serum ALT≤3×UL, AST≤3×ULN#Serum creatinine≤1.5×ULN#

Who cannot join

  • Had used bevacizumab within 6 months of enrollment
  • Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated. The patients had untreated CNS metastases.
  • The patient had Recent intestinal obstruction, gastrointestinal perforation within 3 months, uncontrolled high blood pressure after medication (Systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg), Moderate to severe cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), moderate to severe deep vein thrombosis and moderate to severe pulmonary embolism occurred within 6 months before enrollment. Patient with coagulation dysfunction.
  • Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
  • Activity or uncontrol severe infection

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zou Dongling, PH.D. contact

+8613657690699

cqzl_zdl@163.com

Lin Zhong, M.D. contact

18623393866

zhonglin1983.12.25@126.com

China1 site, 1 recruiting

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Zou Dongling, PH.D., +8613657690699, cqzl_zdl@163.com

    Lin Zhong, M.D., 18623393866, zhonglin1983.12.25@126.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Single-arm, Multicenter Phase Ⅱ Clinical Study of Fluzoparib Combined With Bevacizumab in Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With PARPi

There are more and more PARPi(PARP inhibitors) resistance for ovarian cancer patients after previous use of PARP inhibitors. Basic studies have found that there is synergistic effect of bevacizumab combined with PARPi. Therefore we designed the study to include 42 ovarian cancer patients who had PARPi for at least half a year and then relapsed (platinum-sensitive, previously 1-3 lines of chemotherapy). After getting complete remission or partial remission with chemotherapy containing platinum and bevacizumab, fluzopanib and bevacizumab were used for maintenance treatment. The progression-free survival, ORR, DCR, DoR, and safety were evaluated based on RECIST V1.1.

Read the detailed description

Genetic testing of tissue samples before and after the maintenance therapy were also used to further explore the pattern of gene mutations and the subgroups who may benefit.

Conditions
Ovarian Cancer
Being tested
fluzopanib and bevacizumab
Keywords
PARP inhibitor, Fluzoparib, Bevacizumab, Platinum - sensitive recurrent EOC
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • fluzopanib and bevacizumabDrug

    fluzopanib and bevacizumab were used for maintenance treatment

Study groups in NCT05551208
Study groupRoleWhat they receive
maintenance treatmentExperimentalafter 4-9 cycles chemotherapy containing platinum and bevacizumab, fluzopanib and bevacizumab were used for maintenance treatment
Receives: Drug: fluzopanib and bevacizumab

What is being measured

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

  1. PFS

    progression-free survival was the maintenance time to progression or recurrence since the last platinum therapy based on RECIST v1.1

    Measured: 5 years

Secondary outcomes (4)

  1. OS

    Overall survival

    Measured: 5 years

  2. ORR

    Objective Response Rate

    Measured: 5 years

  3. DCR

    Disease control rate

    Measured: 5 years

  4. DoR

    Duration of remission

    Measured: 5 years

Timeline

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

  1. First posted22 Sep 2022
  2. Study start15 Aug 2022
  3. Primary completion30 Aug 2024 (estimated)
  4. Study completion30 Aug 2029 (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
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05551208
Sponsor's protocol ID
CQGOG0205
Status last verified
Sep 2022
First submitted
31 Aug 2022
Last updated
22 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • van de Laar R, Zusterzeel PL, Van Gorp T, Buist MR, van Driel WJ, Gaarenstroom KN, Arts HJ, van Huisseling JC, Hermans RH, Pijnenborg JM, Schutter EM, Pelikan HM, Vollebergh JH, Engelen MJ, Inthout J, Kruitwagen RF, Massuger LF. Cytoreductive surgery followed by chemotherapy versus chemotherapy alone for recurrent platinum-sensitive epithelial ovarian cancer (SOCceR trial): a multicenter randomised controlled study. BMC Cancer. 2014 Jan 14;14:22. doi: 10.1186/1471-2407-14-22.

    PubMed 24422892

  • Harter P, Sehouli J, Vergote I, Ferron G, Reuss A, Meier W, Greggi S, Mosgaard BJ, Selle F, Guyon F, Pomel C, Lecuru F, Zang R, Avall-Lundqvist E, Kim JW, Ponce J, Raspagliesi F, Kristensen G, Classe JM, Hillemanns P, Jensen P, Hasenburg A, Ghaem-Maghami S, Mirza MR, Lund B, Reinthaller A, Santaballa A, Olaitan A, Hilpert F, du Bois A; DESKTOP III Investigators. Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer. N Engl J Med. 2021 Dec 2;385(23):2123-2131. doi: 10.1056/NEJMoa2103294.

    PubMed 34874631

  • Coleman RL, Brady MF, Herzog TJ, Sabbatini P, Armstrong DK, Walker JL, Kim BG, Fujiwara K, Tewari KS, O'Malley DM, Davidson SA, Rubin SC, DiSilvestro P, Basen-Engquist K, Huang H, Chan JK, Spirtos NM, Ashfaq R, Mannel RS. Bevacizumab and paclitaxel-carboplatin chemotherapy and secondary cytoreduction in recurrent, platinum-sensitive ovarian cancer (NRG Oncology/Gynecologic Oncology Group study GOG-0213): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Jun;18(6):779-791. doi: 10.1016/S1470-2045(17)30279-6. Epub 2017 Apr 21.

    PubMed 28438473

  • Aghajanian C, Blank SV, Goff BA, Judson PL, Teneriello MG, Husain A, Sovak MA, Yi J, Nycum LR. OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol. 2012 Jun 10;30(17):2039-45. doi: 10.1200/JCO.2012.42.0505. Epub 2012 Apr 23.

    PubMed 22529265

  • Alvarez Secord A, O'Malley DM, Sood AK, Westin SN, Liu JF. Rationale for combination PARP inhibitor and antiangiogenic treatment in advanced epithelial ovarian cancer: A review. Gynecol Oncol. 2021 Aug;162(2):482-495. doi: 10.1016/j.ygyno.2021.05.018. Epub 2021 Jun 3.

    PubMed 34090705

  • Ray-Coquard I, Pautier P, Pignata S, Perol D, Gonzalez-Martin A, Berger R, Fujiwara K, Vergote I, Colombo N, Maenpaa J, Selle F, Sehouli J, Lorusso D, Guerra Alia EM, Reinthaller A, Nagao S, Lefeuvre-Plesse C, Canzler U, Scambia G, Lortholary A, Marme F, Combe P, de Gregorio N, Rodrigues M, Buderath P, Dubot C, Burges A, You B, Pujade-Lauraine E, Harter P; PAOLA-1 Investigators. Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2416-2428. doi: 10.1056/NEJMoa1911361.

    PubMed 31851799

  • Fong PC, Boss DS, Yap TA, Tutt A, Wu P, Mergui-Roelvink M, Mortimer P, Swaisland H, Lau A, O'Connor MJ, Ashworth A, Carmichael J, Kaye SB, Schellens JH, de Bono JS. Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers. N Engl J Med. 2009 Jul 9;361(2):123-34. doi: 10.1056/NEJMoa0900212. Epub 2009 Jun 24.

    PubMed 19553641

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fluzopanib and bevacizumab in people with Ovarian Cancer, run by Chongqing University Cancer Hospital at 1 site in China.

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 5 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: looking for participants now, as of the sponsor's last update on 22 Sep 2022. 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 China. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Zou Dongling, PH.D. (+8613657690699, cqzl_zdl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: 5 years). 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 NCT05551208, which also lists 8 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 22 Sep 2022.

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