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A Study of Regorafenib in Advanced Pancreatic Cancer Patients

19. dubna 2022 aktualizováno: Wake Forest University Health Sciences

A Pilot Study Testing Single-Agent Regorafenib in Advanced Previously-Treated Adenocarcinoma of the Pancreas

This study tests regorafenib as a single agent in the treatment of metastatic pancreatic cancer patients who have progressed after prior chemotherapy with gemcitabine. The prognosis for these patients is particularly grim, no other standard treatment options exist, and novel approaches are desperately needed.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

This is a single arm, single stage Phase II study designed to evaluate progression free survival (PFS) in patients with metastatic pancreatic cancer who have failed at least one prior line of therapy and treatment with gemcitabine. This study is open at the Levine Cancer Institute (LCI). A total of 32 patients will be enrolled over a two years. Following informed consent and eligibility check, all patients will start oral regorafenib therapy (120 mg daily for 3 weeks on / 1 week off; 28 day cycle) with a built-in dose escalation to 160mg after the first cycle as tolerated, and will continue therapy until progression or patient withdrawal. Patients will undergo radiological staging after the first two cycles of regorafenib therapy. Patients with progressive disease will be removed from the study. Patients who have at least stable disease will continue regorafenib therapy, at the Investigator's discretion, and will be radiologically restaged bimonthly.

Typ studie

Intervenční

Zápis (Aktuální)

20

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • North Carolina
      • Albemarle, North Carolina, Spojené státy, 28001
        • Levine Cancer Institute-Albemarle
      • Charlotte, North Carolina, Spojené státy, 28204
        • Levine Cancer Institute
      • Charlotte, North Carolina, Spojené státy, 28211
        • Levine Cancer Institute - Southpark
      • Charlotte, North Carolina, Spojené státy, 28262
        • Levine Cancer Institute - University
      • Charlotte, North Carolina, Spojené státy, 28277
        • Levine Cancer Institute - Ballantyne
      • Charlotte, North Carolina, Spojené státy, 28203
        • Levine Cancer Institute-South Tryon
      • Charlotte, North Carolina, Spojené státy, 28210
        • Levine Cancer Institute - Pineville
      • Charlotte, North Carolina, Spojené státy, 28262
        • Levine Cancer Institute - Mallard Creek
      • Concord, North Carolina, Spojené státy, 28025
        • Levine Cancer Institute - Concord
      • Monroe, North Carolina, Spojené státy, 28112
        • Levine Cancer Institute-Monroe
      • Shelby, North Carolina, Spojené státy, 28150
        • Levine Cancer Institute - Cleveland
    • South Carolina
      • Charleston, South Carolina, Spojené státy, 29406
        • Low Country Hematology Oncology

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Adenocarcinoma of the exocrine pancreas with metastatic disease.
  • The site of the primary tumor confirmed to have been within the pancreas.
  • Progression on at least one prior line of chemotherapy for locally-advanced or metastatic pancreatic cancer.
  • Progression while on treatment with a gemcitabine regimen for advanced pancreatic cancer, or within 12 months of treatment with gemcitabine as part of adjuvant therapy.
  • Measurable disease on axial imaging.
  • Age greater than or equal to 18 years.
  • Life expectancy of at least 8 weeks.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2. Enrollment of patients with PS = 2 will be capped at 7 patients.
  • Subjects must be able to understand and be willing to sign the written informed consent form.
  • Acute toxic effects except alopecia of any prior treatment must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grade 1 or less.
  • Adequate bone marrow, renal, and liver function.
  • Warfarin or heparin will be allowed provided that there is no prior evidence of underlying coagulation abnormality.
  • Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
  • Patients (men and women) of childbearing potential must agree to use adequate contraception
  • Patient must be able to swallow and retain oral medication.

Exclusion Criteria:

  • Previous assignment to treatment during this study.
  • Uncontrolled hypertension.
  • Active clinically significant cardiac disease.
  • Cerebrovascular arterial event within 6 months.
  • Evidence or history of bleeding diathesis or coagulopathy.
  • Any bleeding event greater than or equal to NCI CTCAE Grade 3 within 4 weeks.
  • New venous thrombotic or embolic events, such as deep vein thrombosis or pulmonary embolism within 3 months.
  • Previously untreated or concurrent cancer that is distinct in primary site or histology except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor. Patients surviving a cancer that was curatively treated and without evidence of disease for more than 3 years are allowed.
  • Patients with pheochromocytoma.
  • Known history of HIV infection or current chronic or active hepatitis B or C, requiring antiviral medication.
  • Ongoing infection greater than or equal to Grade 2 NCI-CTCAE v4.0.
  • Symptomatic metastatic brain or meningeal tumors.
  • Presence of a non-healing wound, non-healing ulcer, or bone fracture.
  • Renal failure requiring dialysis.
  • Dehydration Grade greater than or equal to 1 NCI-CTCAE v4.0.
  • Patients with seizure disorder requiring medication.
  • Persistent proteinuria greater than or equal to Grade 3 NCI-CTCAE v4.0.
  • Symptomatic interstitial lung disease.
  • Pleural effusion or ascites that cause respiratory compromise.
  • History of organ allograft except corneal transplant.
  • Known or suspected allergy or hypersensitivity to the study drugs.
  • Any severe, uncontrolled malabsorption condition.
  • Women who are pregnant or breast-feeding.
  • Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study.
  • Concurrent anti-cancer therapy other than study treatment (regorafenib).
  • Prior use of regorafenib.
  • Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days.
  • Prior radiation therapy or hepatic arterial therapy is permitted if more than 4 weeks have passed since completion and measurable disease outside of the treated area is present, or if progression since treatment has occurred.
  • Use of St. John's Wort.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Single Arm
Oral Regorafenib
Lék: regorafenib
Single agent drug therapy with regorafenib
Ostatní jména:
  • Stivarga

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Patients Progression Free and Surviving at 16 Weeks as a Percent of All Enrolled Subjects
Časové okno: 16 weeks after enrollment
16-week progression free survival was determined for each subject as a binary variable indicating whether or not the subject is alive and progression free at 16 weeks after treatment start, with progression defined radiographically using RECIST v1.1 or clinically based upon investigator assessment.
16 weeks after enrollment

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Progression Free Survival
Časové okno: From date of treatment start to date of progression or death, or censored as described above; assessed for approximately 3 years.
PFS is defined as duration of time from enrollment to the study to time of progression or death. Disease progression (PD) can be objectively determined as per RECIST v1.1 (Response Evaluation Criteria in Solid Tumors, where PD is defined as a 20% increase in the sum of the longest diseased of target lesions, or a measurable increase in non-target lesion, or the appearance of new lesions) or progression can be subjective as determined by the investigator. Evidence for subjective progressions must be documented in medical records. For surviving subjects who do not have documented PD, PFS will be censored at last radiologic assessment. For subjects who receive subsequent anti-cancer therapy prior to documented PD, PFS will be censored at last radiologic assessment prior to commencement of subsequent therapy. Subjects who experience a PFS event following an interval equal to two or more scheduled CT assessments will be censored at date of last assessment prior to first missed assessment.
From date of treatment start to date of progression or death, or censored as described above; assessed for approximately 3 years.
Overall Survival
Časové okno: From date of treatment start to date of death, or censored as described above; assessed for approximately 3 years.
Overall survival is defined as the duration from enrollment date to the date of death from any cause. Subjects who are alive or lost to follow-up at the time of the analysis will be censored at the last known date they were alive.
From date of treatment start to date of death, or censored as described above; assessed for approximately 3 years.
Overall Response
Časové okno: From enrollment to best response while on regorafenib; Subjects remained on treatment until disease progression or death or discontinuation from study or at least 28 days after last dose (subjects were on treatment for an average of 6 weeks)
Overall response will be determined as the best treatment response for each patient as a binary variable indicating whether or not the patient achieved a Complete Response (CR) or Partial Response (PR) as determined by RECIST v1.1 criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1):Complete Response (CR) is the disappearance of all lesions (target and non target); Partial Response (PR) is at least 30% decrease in the sum of the diameters of target lesions from baseline and no new lesions or unequivocal progression in non target lesions from baseline; Stable Disease (SD) is neither sufficient shrinkage in target lesions to qualify for PR (less than 30% decrease) nor sufficient increase in target lesions (versus smallest sum of diameters) to qualify for PD (less than 20% increase), with no new lesions or unequivocal progression in non target lesions from baseline. For the purposes of response determination, confirmatory scan for CR and PR is not required.
From enrollment to best response while on regorafenib; Subjects remained on treatment until disease progression or death or discontinuation from study or at least 28 days after last dose (subjects were on treatment for an average of 6 weeks)
Disease Control
Časové okno: From enrollment to best response while on regorafenib; Subjects remained on treatment until disease progression or death or discontinuation from study or at least 28 days after last dose (subjects were on treatment for an average of 6 weeks)
Disease control will be determined for each patient as a binary variable indicating whether or not the patient achieved a best overall best response of CR, PR, or stable disease as determined by RECIST v1.1 criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.1): Complete Response (CR) is the disappearance of all lesions (target and non target); Partial Response (PR) is at least 30% decrease in the sum of the diameters of target lesions from baseline and no new lesions or unequivocal progression in non target lesions from baseline; Stable Disease (SD) is neither sufficient shrinkage in target lesions to qualify for PR (less than 30% decrease) nor sufficient increase in target lesions (versus smallest sum of diameters) to qualify for PD (less than 20% increase), with no new lesions or unequivocal progression in non target lesions from baseline.
From enrollment to best response while on regorafenib; Subjects remained on treatment until disease progression or death or discontinuation from study or at least 28 days after last dose (subjects were on treatment for an average of 6 weeks)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Wake Forest University Health Sciences

Spolupracovníci

Bayer

Vyšetřovatelé

  • Vrchní vyšetřovatel: John S Salmon, MD, Atrium Health Levine Cancer Institute
  • Vrchní vyšetřovatel: Edward Kim, MD, Atrium Health Levine Cancer Institute

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

6. června 2014

Primární dokončení (Aktuální)

28. června 2017

Dokončení studie (Aktuální)

28. června 2017

Termíny zápisu do studia

První předloženo

3. března 2014

První předloženo, které splnilo kritéria kontroly kvality

4. března 2014

První zveřejněno (Odhad)

6. března 2014

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. dubna 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

19. dubna 2022

Naposledy ověřeno

1. července 2019

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • LCI-GI-PAN-REG-001

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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