Studie alisertibu v kombinaci s endokrinní terapií u pacientek s HR-pozitivním, HER2-negativním recidivujícím nebo metastatickým karcinomem prsu (ALISCA-Breast1)
Studie fáze 2 alisertibu v kombinaci s endokrinní terapií u pacientek s HR+, HER2-negativní recidivující nebo metastazující rakovinou prsu
PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy. Participants randomized prior to Amendment 4 are randomized 1:1:1 to Arm 1, Arm 2 or Arm 3. Participants randomized under Amendment 4 will be randomized 1:1 to Arm 1 or Arm 2.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
Kontakty a umístění
Studijní kontakt
- Jméno: Puma Biotechnology, Inc. Clinical Operations Senior Director
- Telefonní číslo: 424-248-6500
- E-mail: ClinicalTrials@pumabiotechnology.com
Studijní místa
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Lisbon, Portugalsko, 1998-018
- Nábor
- Hospital CUF Descobertas
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Lisbon, Portugalsko, 1099-023
- Nábor
- Instituto Português de Oncologia de Lisboa Francisco Gentil (IPO Lisboa)
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Lisbon, Portugalsko, 1400-038
- Nábor
- Fundação Champalimaud
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Porto, Portugalsko, 4200-072
- Nábor
- Instituto Português Oncologia Do Porto
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Alabama
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Birmingham, Alabama, Spojené státy, 34235
- Nábor
- Alabama Oncology
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Arizona
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Phoenix, Arizona, Spojené státy, 85054
- Nábor
- Mayo Clinic Hospital
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California
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Beverly Hills, California, Spojené státy, 90211
- Nábor
- Beverly Hills Cancer Center
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Fountain Valley, California, Spojené státy, 92708
- Nábor
- MemorialCare Orange Coast Medical Center
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Irvine, California, Spojené státy, 92618
- Nábor
- City of Hope at Orange County Lennar Foundation Cancer Center
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Los Angeles, California, Spojené státy, 90095
- Nábor
- UCLA Department of Medicine - Hematology/Oncology
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Los Angeles, California, Spojené státy, 90017
- Nábor
- LA Cancer Network
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San Francisco, California, Spojené státy, 94158
- Nábor
- University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
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Colorado
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Aurora, Colorado, Spojené státy, 80045
- Nábor
- University of Colorado School of Medicine
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Connecticut
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New Haven, Connecticut, Spojené státy, 06520
- Staženo
- Yale University, Yale Cancer Center
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Florida
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Jacksonville, Florida, Spojené státy, 32256
- Nábor
- Cancer Specialists of North Florida
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Jacksonville, Florida, Spojené státy, 32224
- Nábor
- Mayo Clinic Florida
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Tampa, Florida, Spojené státy, 33612
- Nábor
- Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, Spojené státy, 30322
- Nábor
- Winship Cancer Institute, Emory University
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Illinois
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Chicago, Illinois, Spojené státy, 60612
- Nábor
- University of Illinois Cancer Center
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Chicago, Illinois, Spojené státy, 60637
- Nábor
- The University of Chicago
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02114
- Nábor
- Massachusetts General Hospital
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Boston, Massachusetts, Spojené státy, 02215
- Nábor
- Dana-Farber Cancer Institute
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Minnesota
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Minneapolis, Minnesota, Spojené státy, 55455
- Nábor
- University of Minnesota, Masonic Cancer Center
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Rochester, Minnesota, Spojené státy, 55905
- Nábor
- Mayo Clinic
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Missouri
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Columbia, Missouri, Spojené státy, 65201
- Nábor
- Missouri Cancer Associates
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Kansas City, Missouri, Spojené státy, 64111
- Nábor
- Saint Luke's Cancer Institute
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Springfield, Missouri, Spojené státy, 65807
- Nábor
- Oncology Hematology Associates
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St Louis, Missouri, Spojené státy, 63110
- Nábor
- Washington University School of Medicine
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Nevada
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Reno, Nevada, Spojené státy, 89511
- Nábor
- Cancer Care Specialists
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New York
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Rochester, New York, Spojené státy, 14642
- Nábor
- University of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, Spojené státy, 27514
- Nábor
- UNC Hospitals, University of North Carolina at Chapel Hill
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Ohio
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Columbus, Ohio, Spojené státy, 43212
- Nábor
- The Ohio State University, Stefanie Spielman Comprehensive Breast Center
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Maumee, Ohio, Spojené státy, 43537
- Nábor
- Taylor Cancer Research Center
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Pennsylvania
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Horsham, Pennsylvania, Spojené státy, 19044
- Nábor
- Alliance Cancer Specialists
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Philadelphia, Pennsylvania, Spojené státy, 19104
- Nábor
- University of Pennsylvania, Abramson Cancer Center, Perelman Center for Advanced Medicine
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Pittsburgh, Pennsylvania, Spojené státy, 15213
- Nábor
- University of Pittsburgh (UPMC)
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Tennessee
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Nashville, Tennessee, Spojené státy, 37203
- Nábor
- Tennessee Oncology, Greco-Hainsworth Center for Research
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Texas
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Dallas, Texas, Spojené státy, 75246
- Nábor
- Texas Oncology
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Virginia
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Richmond, Virginia, Spojené státy, 23229
- Nábor
- Virginia Cancer Institute
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Alicante, Španělsko, 03010
- Nábor
- Hospital General Universitario Dr. Balmis
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Barakaldo, Španělsko, 48903
- Nábor
- Hospital Universitario de Cruces
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Barcelona, Španělsko, 08035
- Nábor
- Hospital Universitario Vall d'Hebron
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Barcelona, Španělsko, 08036
- Nábor
- Hospital Clínico de Barcelona
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Bilbao, Španělsko, 48013
- Nábor
- Hospital Universitario de Basurto
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Cáceres, Španělsko, 10003
- Nábor
- Hospital San Pedro de Alcántara
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Granada, Španělsko, 18012
- Nábor
- Hospital San Cecilio
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Huelva, Španělsko, 21005
- Nábor
- Hospital Universitario Juan Ramon Jimenez
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Jaén, Španělsko, 23007
- Nábor
- Hospital Universitario de Jaén
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Lleida, Španělsko, 25198
- Nábor
- Hospital Universitario Arnau de Vilanova
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Madrid, Španělsko, 28040
- Nábor
- Hospital Universitario Fundación Jiménez Díaz
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Seville, Španělsko, 41013
- Nábor
- Hospital Universitario Virgen del Rocío
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Valencia, Španělsko, 46010
- Nábor
- Hospital Clínico Universitario de Valencia
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Valencia, Španělsko, 46009
- Nábor
- Fundación Instituto Valenciano de Oncología (IVO)
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Aged ≥18 years at signing of informed consent.
- Pathology-confirmed diagnosis of breast cancer with evidence of recurrent or metastatic disease not amenable to curative therapy.
- Progression on or after treatment with at least two prior lines of endocrine therapy in the recurrent or metastatic setting. a. If metastatic disease recurrence occurs during or within six months of discontinuing adjuvant endocrine therapy, then that endocrine therapy will count as one line of prior therapy.
- Participants must have received a CDK4/6i in combination with endocrine therapy in the recurrent or metastatic setting.
- HR-positive and HER2-negative tumor status reported per local laboratory testing. HR and HER2 testing must be performed consistent with current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) or European Society of Medical Oncology (ESMO) guidelines.
Exclusion Criteria:
- Treatment with chemotherapy in the recurrent or metastatic setting, including antibody drug conjugates with a chemotherapeutic payload.
- Prior treatment with an Aurora Kinase A (AURKA) specific-targeted or pan-Aurora-targeted agent, including alisertib, in any setting.
Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Alisertib 50 mg
Alisertib with selected endocrine therapy |
Alisertib enteric-coated tablets will be taken by mouth twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.
Ostatní jména:
Investigator selected endocrine therapy will be taken in 28-day dosing cycles according to the approved prescribing information. 1 mg of anastrozole tablet by mouth once daily or 2.5 mg of letrozole tablet by mouth once daily or 25 mg of exemestane tablet by mouth once daily or 20 mg of tamoxifen tablet by mouth once daily or 500 mg of fulvestrant intramuscular injection on Study Day 1, 15, 29, and once every 28 days thereafter |
|
Experimentální: Alisertib 40 mg
Alisertib with selected endocrine therapy |
Alisertib enteric-coated tablets will be taken by mouth twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.
Ostatní jména:
Investigator selected endocrine therapy will be taken in 28-day dosing cycles according to the approved prescribing information. 1 mg of anastrozole tablet by mouth once daily or 2.5 mg of letrozole tablet by mouth once daily or 25 mg of exemestane tablet by mouth once daily or 20 mg of tamoxifen tablet by mouth once daily or 500 mg of fulvestrant intramuscular injection on Study Day 1, 15, 29, and once every 28 days thereafter |
|
Experimentální: Alisertib 30 mg
Alisertib with selected endocrine therapy Cohort closed to enrollment in Amendment 4 |
Alisertib enteric-coated tablets will be taken by mouth twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.
Ostatní jména:
Investigator selected endocrine therapy will be taken in 28-day dosing cycles according to the approved prescribing information. 1 mg of anastrozole tablet by mouth once daily or 2.5 mg of letrozole tablet by mouth once daily or 25 mg of exemestane tablet by mouth once daily or 20 mg of tamoxifen tablet by mouth once daily or 500 mg of fulvestrant intramuscular injection on Study Day 1, 15, 29, and once every 28 days thereafter |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Objective Response Rate (ORR) Within Dose Subgroup
Časové okno: From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
|
Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study. |
From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
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Duration of Response (DOR) Within Dose Subgroup
Časové okno: From start date of response (after date of randomization) to first PD, assessed up to 48 months
|
Duration of response is measured from the time at which measurement criteria are first met for Complete Response (CR) or Partial Response (PR) (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented. |
From start date of response (after date of randomization) to first PD, assessed up to 48 months
|
|
Disease Control Rate (DCR) Within Dose Subgroup
Časové okno: From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
|
Disease control rate is the proportion of participants who achieve overall tumor response (confirmed CR or PR) or Stable Disease (SD) lasting for at least 24 weeks from randomization. |
From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
|
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Progression Free Survival (PFS) Within Dose Subgroup
Časové okno: From date of randomization to date of recurrence, progression or death, assessed up to 48 months
|
Progression Free Survival (PFS) is measured in months and based on the local tumor assessment. The time interval from the date of randomization until the first date on which recurrence, progression, or death due to any cause, is documented. |
From date of randomization to date of recurrence, progression or death, assessed up to 48 months
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Overall Survival (OS) Within Dose Subgroup
Časové okno: From date of randomization to death, assessed up to 48 months
|
Overall survival (OS) is defined as the time from randomization to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier. |
From date of randomization to death, assessed up to 48 months
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Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the Enrolled Population
Časové okno: From date of first dose through last dose plus 28 days, assessed up to 48 months
|
Treatment emergent adverse events are those events reported on or after the first dose of investigational product and up to 28 days after last dose. |
From date of first dose through last dose plus 28 days, assessed up to 48 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Objective Response Rate (ORR) Within Biomarker-Defined Subgroup
Časové okno: From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
|
Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study. |
From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
|
|
Duration of Response (DOR) Within Biomarker-Defined Subgroup
Časové okno: From start date of response (after date of randomization) to first PD, assessed up to 48 months
|
Duration of response is measured from the time at which measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented. |
From start date of response (after date of randomization) to first PD, assessed up to 48 months
|
|
Disease Control Rate (DCR) Within Biomarker-Defined Subgroup
Časové okno: From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
|
Disease control rate is the proportion of participants who achieve overall tumor response (confirmed CR or PR) or SD lasting for at least 24 weeks from randomization. |
From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
|
|
Progression Free Survival (PFS) Within Biomarker-Defined Subgroup
Časové okno: From date of randomization to date of recurrence, progression or death, assessed up to 48 months
|
Progression Free Survival (PFS) is measured in months and based on the local tumor assessment. The time interval from the date of randomization until the first date on which recurrence, progression, or death due to any cause, is documented. |
From date of randomization to date of recurrence, progression or death, assessed up to 48 months
|
|
Overall Survival (OS) Within Biomarker-Defined Subgroup
Časové okno: From date of randomization to death, assessed up to 48 months
|
Overall survival (OS) is defined as the time from randomization to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier. |
From date of randomization to death, assessed up to 48 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Chief Reg Affairs, PV, Medical Affairs and Law Officer, Puma Biotechnology, Inc.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- PUMA-ALI-1201
- 2024-511497-79-00 (Ctis)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.
In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.
Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.
Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.
Časový rámec sdílení IPD
Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.
Kritéria přístupu pro sdílení IPD
Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest.
Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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