A Study of Regorafenib in Advanced Pancreatic Cancer Patients
tiistai 19. huhtikuuta 2022 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
20
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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North Carolina
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Albemarle, North Carolina, Yhdysvallat, 28001
- Levine Cancer Institute-Albemarle
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Charlotte, North Carolina, Yhdysvallat, 28204
- Levine Cancer Institute
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Charlotte, North Carolina, Yhdysvallat, 28211
- Levine Cancer Institute - Southpark
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Charlotte, North Carolina, Yhdysvallat, 28262
- Levine Cancer Institute - University
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Charlotte, North Carolina, Yhdysvallat, 28277
- Levine Cancer Institute - Ballantyne
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Charlotte, North Carolina, Yhdysvallat, 28203
- Levine Cancer Institute-South Tryon
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Charlotte, North Carolina, Yhdysvallat, 28210
- Levine Cancer Institute - Pineville
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Charlotte, North Carolina, Yhdysvallat, 28262
- Levine Cancer Institute - Mallard Creek
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Concord, North Carolina, Yhdysvallat, 28025
- Levine Cancer Institute - Concord
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Monroe, North Carolina, Yhdysvallat, 28112
- Levine Cancer Institute-Monroe
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Shelby, North Carolina, Yhdysvallat, 28150
- Levine Cancer Institute - Cleveland
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South Carolina
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Charleston, South Carolina, Yhdysvallat, 29406
- Low Country Hematology Oncology
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: Single Arm
Oral Regorafenib
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Single agent drug therapy with regorafenib
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Number of Patients Progression Free and Surviving at 16 Weeks as a Percent of All Enrolled Subjects
Aikaikkuna: 16 weeks after enrollment
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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.
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16 weeks after enrollment
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Progression Free Survival
Aikaikkuna: From date of treatment start to date of progression or death, or censored as described above; assessed for approximately 3 years.
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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.
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From date of treatment start to date of progression or death, or censored as described above; assessed for approximately 3 years.
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Overall Survival
Aikaikkuna: From date of treatment start to date of death, or censored as described above; assessed for approximately 3 years.
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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.
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From date of treatment start to date of death, or censored as described above; assessed for approximately 3 years.
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Overall Response
Aikaikkuna: 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)
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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.
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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)
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Disease Control
Aikaikkuna: 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)
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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.
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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)
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Yhteistyökumppanit
Tutkijat
- Päätutkija: John S Salmon, MD, Atrium Health Levine Cancer Institute
- Päätutkija: Edward Kim, MD, Atrium Health Levine Cancer Institute
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Perjantai 6. kesäkuuta 2014
Ensisijainen valmistuminen (Todellinen)
Keskiviikko 28. kesäkuuta 2017
Opintojen valmistuminen (Todellinen)
Keskiviikko 28. kesäkuuta 2017
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Maanantai 3. maaliskuuta 2014
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Tiistai 4. maaliskuuta 2014
Ensimmäinen Lähetetty (Arvio)
Torstai 6. maaliskuuta 2014
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Torstai 21. huhtikuuta 2022
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Tiistai 19. huhtikuuta 2022
Viimeksi vahvistettu
Maanantai 1. heinäkuuta 2019
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- LCI-GI-PAN-REG-001
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
EI
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