A Phase 2 interventional study of Pamiparib in Epithelial Ovarian Cancer, sponsored by Zhejiang Cancer Hospital. Active, not recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-26.
Sponsored by Zhejiang Cancer Hospital · Phase 2, Interventional, and Treatment
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
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 15 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Zhejiang Cancer Hospital is the lead sponsor of 271 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients must have received one prior PARP inhibitor therapy:
Patients must have adequate organ function as indicated by the following laboratory values:
Exclusion Criteria:
Patients with any of the following cardiovascular criteria:
i. 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
Pregnancy or nursing:
i. Females of childbearing potential require a negative serum pregnancy test ≤ 7 days before Day 1.
Previous complete gastric resection, chronic diarrhea, active inflammatory gastrointestinal disease, or any other disease-causing malabsorption syndrome.
i. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed.
Drug: Pamiparib
Pamiparib, 60mg PO BID
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
Time frame: Up to approximately 18 months
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
Time frame: Up to approximately 18 months
ORR
Overall Response Rate(ORR), ORR of Pamiparib in patients with EOC were assessed by investigators according to RECIST v 1.1
Time frame: Up to approximately 18 months
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
Time frame: Up to approximately 18 months
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.
Time frame: Up to approximately 21 months
This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Zhejiang Cancer Hospital