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Epithelial Ovarian CancerPhase 2NCT05489926

A Study to Explore Pamiparib Treatment in Epithelial Ovarian Cancer After Prior PARP Inhibitor Exposure

A Phase 2 study testing Pamiparib in people with Epithelial Ovarian Cancer, run by Zhejiang Cancer Hospital at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The PamiAP will be a Phase II, single-arm, open label study to explore the efficacy and safety of Pamiparib treatment in patients with Epithelial Ovarian Cancer（EOC） who have had exposure to prior a PARP (poly(ADP-ribose)-polymerase) inhibitor Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Epithelial Ovarian Cancer
What is being tested?
Pamiparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
16 Aug 2022to Dec 2024
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary participation and signature of informed consent;
  • Age ≥18;
  • Histologically diagnosed relapsed non-mucinous epithelial ovarian cancer (EOC) (including primary peritoneal and/or fallopian tube cancer), including platinum-sensitive and platinum-resistant patients, and the proportion of platinum-resistant patients was less than 40%
  • ≥2 previous lines of treatment
  • Patients must have received one prior PARP inhibitor therapy:
  • Prior PARP inhibitor for maintenance treatment: the duration of prior PARP inhibitor exposure must have been ≥12 months following a first line of chemotherapy or ≥6 months following a second or subsequent line of chemotherapy
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  • Prior PARP inhibitor for treatment: the duration of prior PARP inhibitor exposure must have been ≥4 months
  • Patients must have lesions that can be measured according to RECIST v1.1 criteria;
  • Life expectancy ≥16 weeks;
  • Eastern United States Cancer Collaboration Group (ECOG) score 0-1;
  • Pregnant women must agree to effective contraception ≥120 days during the study period and after the last drug administration, and the results of serum pregnancy tests were negative 7 days ≤ before the first drug administration;
  • Patients must have adequate organ function as indicated by the following laboratory values:
  • Hemoglobin ≥ 9 g/dL
  • Absolute neutrophil count (ANC) ≥1.5 x 109/L
  • Platelets ≥ 80 x 109/L
  • Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN
  • Serum creatinine <1.5 x ULN

Who cannot join

  • Prior treatment with Pamiparib;
  • Patients who are candidates for surgery after disease progression;
  • Patients who have been treated with chemotherapy, biologic therapy, immunotherapy, investigational agent, anti-cancer Chinese medicine, or anti-cancer herbal remedies ≤ 14 days (or ≤5 half-lives, whichever is shorter) prior to starting study drug, or who have not adequately recovered from the side effects of such therapy;
  • Patients who have undergone major surgery/surgical therapy for any cause ≤ 4 weeks prior to starting study drug. Patients must have adequately recovered from the treatment and have a stable clinical condition before entering the study;
  • Patients who have undergone radiotherapy for any cause ≤ 14 days prior to starting study drug. Patients must have adequately recovered from the previous treatment and have a stable clinical condition before entering the study;
  • Untreated and/or active brain metastases; i. A scan to confirm the absence of brain metastases is not required ii. Patients with treated brain metastases must be off corticosteroids for ≥ 14 days and have no signs or symptoms of progressive brain metastases
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  • Inability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation
  • Patients with any of the following cardiovascular criteria:
  • Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days prior to Day 1 ii. Evidence of symptomatic pulmonary embolismwithin 4 weeks prior to Day 1 iii. Acute myocardial infarction ≤ 6 months prior to Day 1 iv. Heart failure of New York Heart Association Classification III or IV (see Appendix 12) ≤ 6 months prior to Day 1 v. ≥ Grade 2 ventricular arrhythmia ≤ 6 months prior to Day 1 vi. Cerebrovascular accident ≤ 6 months prior to Day 1
  • Patients with other malignant cancer i. Except for surgically excised non-melanoma skin cancer, adequately treated carcinoma in situ of the cervix, adequately treated low-stage bladder cancer, ductal carcinoma in situ treated surgically with curative intent, or a malignancy diagnosed ≥ 5 years ago with no current evidence of disease and no therapy ≥ 5 years prior to Day 1
  • Diagnosis of myelodysplastic syndrome (MDS);
  • Known human immunodeficiency virus (HIV) infection, active viral hepatitis, or active tuberculosis;
  • Use ≤ 10 days (or ≤ 5 half-lives, whichever is shorter), prior to Day 1, or anticipated need for food or drugs known to be strong or moderate cytochrome P450 (CYP) 3A inhibitors or strong CYP3A inducers;
  • Pregnancy or nursing:
  • Females of childbearing potential require a negative serum pregnancy test ≤ 7 days before Day 1.
  • Known history of intolerance to the excipients of the pamiparib capsule;
  • Previous complete gastric resection, chronic diarrhea, active inflammatory gastrointestinal disease, or any other disease-causing malabsorption syndrome.
  • Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed.
  • Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, significant hemoptysis, or melena ≤ 6 months before Day 1;
  • Any illness that investigator thinks makes the patient unsuitable for entry into the study;
  • Unsolved acute effects of prior therapy of ≥ Grade 2 i. Except for AEs not considered a likely safety risk (eg, alopecia, neuropathy, and specific laboratory abnormalities)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

Other trials in China

About this study

The PamiAP will be a Phase II, single-arm, open label study to explore the efficacy and safety of Pamiparib treatment in patients with Epithelial Ovarian Cancer（EOC） who have had exposure to prior a PARP (poly(ADP-ribose)-polymerase) inhibitor

Read the detailed description

The landscape for treatment of Epithelial Ovarian Cancer（EOC） is rapidly changing. With the release of data from numerous studies exploring the role of PARP (poly(ADP-ribose)-polymerase) inhibitor as maintenance and treatment, approval has expanded significantly in recent years. However, with the widespread exposure of PARP inhibitor in the patients, whether another PARP inhibitor can be reused in patients with PARP inhibitor resistance or disease progression. We have no data regarding the efficacy or safety of a PARP inhibitor retreatment in patients who have had exposure to prior a PARP inhibitor.

The objective of this study was to evaluate the efficacy and safety of Pamiparib in patients with EOC who had previously been treated with PARP inhibitor, and to explore the characteristics of patients who responded to PARP inhibitor again.

Being tested
Pamiparib
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

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

  • PamiparibDrug

    Pamiparib, 60mg PO BID

Study groups in NCT05489926
Study groupRoleWhat they receive
PamiparibExperimentalNot described
Receives: Drug: Pamiparib

What is being measured

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

  1. CBR at 4 months

    Clinical Benefit Rate (CBR) was defined as percentage of participants with confirmed best overall response of complete response (CR), partial response (PR), stable disease (SD) sustained for at least 4 months was assessed by investigators according to RECIST v1.1

    Measured: Up to approximately 18 months

Secondary outcomes (4)

  1. PFS

    Progression-free Survival（PFS）, the time from the first dosing of the study drug until the first objective recording of disease progression or death from any cause, whichever occurred first

    Measured: Up to approximately 18 months

  2. ORR

    Overall Response Rate（ORR）, ORR of Pamiparib in patients with EOC were assessed by investigators according to RECIST v 1.1

    Measured: Up to approximately 18 months

  3. DOR

    Duration of Response（DOR）, refers to the time from the beginning of the first assessment of a tumor as CR or PR to the first assessment of PD or death from any cause were assessed by investigators according to RECIST v 1.1

    Measured: Up to approximately 18 months

  4. AE

    Adverse Event（AE）, an AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be presented.

    Measured: Up to approximately 21 months

Timeline

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

  1. First posted5 Aug 2022
  2. Study start16 Aug 2022
  3. Primary completionJun 2024 (estimated)
  4. Study completionDec 2024 (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
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05489926
Sponsor's protocol ID
PamiAP
Status last verified
Jan 2024
First submitted
4 Aug 2022
Last updated
26 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pamiparib in people with Epithelial Ovarian Cancer, run by Zhejiang 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 18 inclusion and 21 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 26 Jan 2024. 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?

Results are not available in the source record.

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?

CBR at 4 months (time frame: Up to approximately 18 months). 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 NCT05489926.

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 26 Jan 2024.

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