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Ovarian CancerPhase 1NCT03075462

A Study of Fluzoparib Given in Combination With Apatinib in Ovarian or Breast Cancer Patients

A Phase 1 study testing Fluzoparib and Apatinib in people with Ovarian Cancer and Triple Negative Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Fluzoparib is an oral potent, selective poly-ADP ribose polymerase-1 (PARP-1) and PARP-2 inhibitor; Apatinib is an oral selective vascular endothelial growth factor receptor (VEGFR) inhibitor. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Ovarian Cancer, Triple Negative Breast Cancer
What is being tested?
Fluzoparib and Apatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
1 siteChina
Study dates
9 Mar 2017to 13 Dec 2021
Phase
Phase 1
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 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Life expectancy of more than 12 weeks.
  • Histologically or cytologically confirmed high-grade papillary-serous epithelial ovarian cancer，primary peritoneal, or fallopian tube cancers; subjects with a known deleterious breast cancer gene (BRCA) mutation and any other high-grade histology are also eligible. Subjects should have platinum-sensitive disease, where platinum-sensitive disease is defined as having had a > 6 month interval since last receiving platinum therapy prior to disease recurrence. Additionally, subjects with histologically or cytologically confirmed triple negative breast cancer (TNBC）, that is locally advanced or metastatic, are also eligible.
  • Prior therapy：subjects with ovarian cancer，primary peritoneal, or fallopian tube cancers have received only 2 lines of platinum-based chemotherapies, and TNBC patients have received only 1 line of standard chemotherapy. Each prior chemotherapy must be given for at least 2 cycles.
  • At least one measurable lesion that can be accurately assessed by imaging (CT/MRI) at baseline
  • Subjects who have overall good overall general condition.
  • Signed informed consent.

Who cannot join

  • Subjects who received any previous treatment with any PARP inhibitors.
  • Subjects who received any previous treatment with any VEGFR inhibitors.
  • Less than 4 weeks from the last clinical trial.
  • Less than 4 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment and target therapy.
  • Unstable or uncontrolled hypertension.
  • Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption.
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  • Subjects with brain metastases.
  • Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
  • Subjects with a known hypersensitivity to fluzoparib, apatinib or any of the excipients of the products.
  • Ongoing infection (determined by investigator).
  • History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
  • Pregnant or breast-feeding women.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hosptial

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Official title: An Open, Non-randomised, Multi-centre Phase I Study to Assess the Safety and Efficacy of Fluzoparib Given in Combination With Apatinib in Patients With Recurrent Ovarian Cancer or Triple Negative Breast Cancer

Fluzoparib is an oral potent, selective poly-ADP ribose polymerase-1 (PARP-1) and PARP-2 inhibitor; Apatinib is an oral selective vascular endothelial growth factor receptor (VEGFR) inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best dose of fluzoparib in combination with apatinib and to see how well these two drugs work together in the treatment of patients with recurrent ovarian cancer or triple negative breast cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored. Both dose escalation and dose expansion parts are included in this study.

Being tested
Fluzoparib, Apatinib
Keywords
PARP inhibitor, VEGFR inhibitor, Combination therapy, Ovarian Cancer, Triple Negative Breast Cancer
Medical subject headings
Ovarian Neoplasms, Triple Negative Breast Neoplasms

What participants receive

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

  • FluzoparibDrug

    Also called SHR3162, HS10160

    Fluzoparib either at 40,60,80mg twice daily,capsule oral.

  • ApatinibDrug

    Apatinib at 250mg once daily, tablet oral

Study groups in NCT03075462
Study groupRoleWhat they receive
Fluzoparib + ApatinibExperimentalFluzoparib and apatinib will be separately administered to patients on the 1st and 4th day, respectively. Then from the 7th day they are administered continuously and orally in combination, 28 days per cycle, until disease progression or unacceptable toxicity.
Receives: Drug: Fluzoparib; Drug: Apatinib

What is being measured

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

  1. The type and incidence of adverse events [safety and tolerability]

    Adverse events defined according to Common Terminology for Adverse Events (CTCAE) v4.03

    Measured: From screening up to 28 days after end of treatment

Secondary outcomes (9)

  1. Objective Response Rate (ORR)

    [Complete response + Partial response (CR+PR)] based on RECIST 1.1

    Measured: 24 months (approx) from the start of treatment

  2. Disease Control Rate (DOR)

    [Complete response + Partial response + Stable disease (CR+PR+SD)] based on RECIST 1.1

    Measured: 24 months (approx) from the start of treatment

  3. Time to Progression (TTP)

    The time from start of the treatment until radiographic disease progression or CA-125 progression specific for ovarian cancer patients

    Measured: From date of enrollment until the date of first objective progression or CA-125 progression (only for ovarian cancer patients), assessed up to 36 months

  4. Overall Survival (OS)

    Time from start of fluzoparib treatment until death due to any cause

    Measured: From Cycle 1, Day 1 until death or up to 48 months (approx)

  5. Cmax

    Maximum Plasma Concentration

    Measured: From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment

  6. T1/2 (Half-life)

    The time required for the plasma concentration of a drug to be reduced by 50%

    Measured: From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment

  7. Area under curve (AUC)

    Area under the plasma concentration-time curve

    Measured: Within the first 5 weeks from start of fluzoparib treatment

  8. V/F

    Volume of distribution

    Measured: From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment

  9. CL/F

    Plasma Clearance

    Measured: From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment

Timeline

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

  1. First posted9 Mar 2017
  2. Study start9 Mar 2017
  3. Primary completion22 Aug 2021
  4. Study completion13 Dec 2021

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03075462
Sponsor's protocol ID
FZPL-I-104-OC/BC
Status last verified
Jun 2022
First submitted
6 Mar 2017
Last updated
1 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Liu Y, Wang W, Yin R, Zhang Y, Zhang Y, Zhang K, Pan H, Wang K, Lou G, Li G, Zhang R, Li K, Rao J, Zhang B, Wang Y, Wang Q, Gao Y, Li H. A phase 1 trial of fuzuloparib in combination with apatinib for advanced ovarian and triple-negative breast cancer: efficacy, safety, pharmacokinetics and germline BRCA mutation analysis. BMC Med. 2023 Sep 29;21(1):376. doi: 10.1186/s12916-023-03046-8.

    PubMed 37775744

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fluzoparib and Apatinib in people with Ovarian Cancer and Triple Negative Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. 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 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: finished, as of the sponsor's last update on 1 Jul 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The type and incidence of adverse events [safety and tolerability] (time frame: From screening up to 28 days after end of treatment). 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 NCT03075462, which also lists 1 linked publication.

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 1 Jul 2022.

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