- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05327621
Pamiparib in mCRPC With HRD or BRCA1/2 Mutation
A Single Arm, Open-label, Phase II Study to Assess the Efficacy of Pamiparib in Metastatic Castration-Resistant Prostate Cancer Patients With Homologous Recombination Deficiency (HRD) or BRCA1/2 Mutation
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Forventet)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Fangjian Zhou, M.D.
- Telefonnummer: 020-87343656
- E-post: zhoufj@sysucc.org.cn
Studiesteder
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510060
- Rekruttering
- Sun Yat-Sen University Cancer Center
-
Ta kontakt med:
- Fangjian Zhou, M.D.
- Telefonnummer: 020-87343656
- E-post: zhoufj@sysucc.org.cn
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- ≥18 years old, male
- Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma without neuroendocrine differentiation of the prostate. Mixed histology is accepted, except for small cell carcinoma.
- Have a deleterious mutation in BRCA1/2 , or HRD score ≥ 9.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- BPI<4
- Metastatic Castration-resistant Prostate Cancer (mCRPC): Presence of measurable target lesion according to RECIST criteria v1.1
- Male subject has been surgically or medically sterilized and has serum testosterone level ≤1.73nmol/L.
- Unsterilized male subject uses an acceptable method of contraception (defined as a barrier method with spermicide) to prevent pregnancy during the duration of the study and for 6 months after the last dose of Pamiparib.
- Experienced disease progression after having received at least 1 prior next-generation androgen receptor-targeted therapies, for metastatic castration-resistant disease.
- Capable of swallowing the whole capsule.
Subjects must have normal organ and bone marrow function at baseline, as defined below:
Hemoglobin ≥ 9.0 g/dL at least 28 days after transfusion . Absolute neutrophil count ≥ 1.5 × 10^9/L. Platelet count ≥ 100 × 10^9/L. Total bilirubin ≤ 1.5 × the upper limit of normal (ULN) specified. Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase/alanine aminotransferase (ALT) serum glutamic pyruvic transaminase) ≤ 3 × the specified ULN, unless liver metastases are present, in which case it must be ≤ 5 × ULN.
- Agree to sign informed consent form
- Agree not to participate in other interventional trials during this trial.
Exclusion Criteria:
Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- Acute toxicity (CTCAE > grade 2) due to prior cancer therapy.
- Received chemotherapy, endocrine therapy, biotherapy, radionuclide therapy, immunotherapy, experimental drugs, proprietary anticancer drugs or Chinese herbal medicines within 5 (if known) half-lives or 14 days(if unknown) prior to the first day of taking Pamiparib; For bisphosphonates or approved bone targeting therapy, Pamiparib must be administered at a steady dose for ≥28 days prior to the first day of taking Pamiparib.
- Received radiation therapy within 21 days.
- Prior treatment with any PARP inhibitor. Prior chemotherapy with mitoxantrone or platinum-based chemotherapy or cyclophosphamide. Prior treatment with sipuleucel-T or immune check point inhibitors are allowed.
- Subjects with major surgery within 2 weeks before starting study treatment. Subjects expected to receive major surgery during the trial.
- Active second malignancy, with the exception of curatively treated non-melanoma skin cancer, carcinoma in situ, or superficial bladder cancer
- Symptomatic and/or untreated central nervous system metastases
- Immunocompromised subjects, such as those with positive human immunodeficiency virus (HIV) serology.
- Subjects with known active hepatitis (e.g. hepatitis B or C).
- The subject has a serious cardiovascular disease. ( For example, but not limited to: uncontrolled arrhythmia, myocardial infarction)
- Concomitant use of strong CYP3A inducers or moderate CYP3A inducers . If half-lives is known, a 5 half-lives washout period is required before the start of Pamiparib therapy and a 2-week washout period is required when the half-lives is unknown.
- History of intolerance to Pamiparib capsule excipients
- Excluded by investigators
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Pamiparib
Tablets 20mg per os : 40 mg / bid every day in continuous.
Patients will be treated with Pamiparib.
Cycles are defined in 28-day periods.
Disease response will be assessed every 8 weeks (RECIST 1.1).
Safety will be assessed continuously.
|
40 mg bid per os , 28 day cycle, number of cycles: until progression or unacceptable toxicity develops.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Radiologic Progression-free Survival (rPFS)
Tidsramme: 3 years
|
Radiologic progression-free survival will be assessed from the time of the first dose to radiologic disease progression or death from any cause, whichever comes first.
|
3 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Klinisk fordelsrate
Tidsramme: 3 år
|
ifølge RECIST er enten fullstendig respons (CR), partiell respons (PR) eller stabil sykdom (SD) som varer i minst 16 uker
|
3 år
|
Objective Response Rate (ORR)
Tidsramme: From enrollment to primary completion of study (up to approximately 3 years)
|
Proportion of patients in complete remission (CR) plus partial remission (PR)
|
From enrollment to primary completion of study (up to approximately 3 years)
|
Duration of Response (DOR)
Tidsramme: From enrollment to primary completion of study (up to approximately 3 years)
|
Time from the start of the first assessment of the tumor as CR or PR to the first assessment of PD (Progressive Disease) or death from any cause.
|
From enrollment to primary completion of study (up to approximately 3 years)
|
Time to Response (TTR)
Tidsramme: From enrollment to primary completion of study (up to approximately 3 years)
|
Time from initiation of treatment to first assessment of tumor as CR or PR.
|
From enrollment to primary completion of study (up to approximately 3 years)
|
Prostate Specific Antigen (PSA) Response Rate
Tidsramme: From enrollment to primary completion of study (up to approximately 3 years)
|
Proportion of patients with a 50% decrease in PSA from baseline
|
From enrollment to primary completion of study (up to approximately 3 years)
|
Time to PSA Progression
Tidsramme: From enrollment to primary completion of study (up to approximately 3 years)
|
Time from initiation of treatment to two consecutive 50% PSA increases from baseline level
|
From enrollment to primary completion of study (up to approximately 3 years)
|
Overall Survival (OS)
Tidsramme: From enrollment to primary completion of study (up to approximately 3 years)
|
Time between the start of treatment and death from any cause
|
From enrollment to primary completion of study (up to approximately 3 years)
|
Adverse events
Tidsramme: 3 years
|
Adverse events are graded according to the CTCAE V4.03
|
3 years
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
rPFS stratified by baseline HRD score (HRD score threshold is defined as 9)
Tidsramme: 3 years
|
The rPFS is defined as the duration from Pamiparib initiation to radiologic disease progression or death from any cause, whichever comes first.
|
3 years
|
OS stratified by baseline HRD score (HRD score threshold is defined as 9)
Tidsramme: 3 years
|
The OS is defined as the duration from Pamiparib initiation to any death.
|
3 years
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2021-FXY-385
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Pamiparib
-
BeiGeneFullførtAvanserte solide svulsterStorbritannia
-
Peter MacCallum Cancer Centre, AustraliaRekruttering
-
Fudan UniversityRekrutteringSmåcellet lungekreft i begrenset stadiumKina
-
BeiGeneAvsluttetMetastatisk kastrasjonsresistent prostatakreft (mCRPC) | Homolog rekombinasjonsmangel (HRD)Forente stater, Australia, Puerto Rico, Spania
-
Australia New Zealand Gynaecological Oncology GroupBeiGeneTilbaketrukket
-
Bai-Rong XiaRekruttering
-
BeiGeneFullført
-
BeiGeneAktiv, ikke rekrutterende
-
BeiGene USA, Inc.FullførtSvulster i hjernen og sentralnervesystemetForente stater, Nederland, Sveits
-
BeiGeneMyriad Genetic Laboratories, Inc.FullførtSolide svulsterForente stater, Spania, Storbritannia, Frankrike, Australia, New Zealand