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Study to Evaluate Efficacy of CO-1.01 as Second Line Therapy for Gemcitabine-Refractory Stage IV Pancreatic Adenocarcinoma

5. mars 2019 oppdatert av: Clovis Oncology, Inc.

A Phase II, Open-Label, Multicenter Study to Evaluate the Antitumor Efficacy of CO-1.01 for Infusion as Second-Line Therapy for Gemcitabine- Refractory Patients With Stage IV Pancreatic Adenocarcinoma and No Tumor hENT1 Expression

The purpose of this study is to determine whether CO-1.01 is safe and effective for treating metastatic pancreatic cancer that did not respond to gemcitabine.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Pancreatic tumors with low hENT1 expression may show less benefit from gemcitabine compared with those with higher expression of this nucleoside transporter. Nonclinical studies indicate that CO-1.01, a gemcitabine derivative, is effective independent of such transporters. Thus patients with low or no meaningful expression of hENT1 who failed to respond to gemcitabine might derive benefit from CO1.01 before needing alternative (combination) chemotherapy. Furthermore, the PK profiles of CO-1.01 and gemcitabine are dissimilar and this may confer additional clinical benefit on CO1.01.

Studietype

Intervensjonell

Registrering (Faktiske)

19

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arizona
      • Tucson, Arizona, Forente stater, 85724
        • Arizona Cancer Center at University of Arizona
    • Colorado
      • Denver, Colorado, Forente stater, 80218
        • Rocky Mountain Cancer Center
    • Florida
      • Boynton Beach, Florida, Forente stater, 33425
        • Palm Beach Institute / Collaborative Research Group
      • Miami, Florida, Forente stater, 33136
        • University of Miami
    • Georgia
      • Atlanta, Georgia, Forente stater, 30309
        • Piedmont Healthcare Research Institute (PHRI)
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40202
        • Norton Cancer Institute Research Program
    • Maryland
      • Baltimore, Maryland, Forente stater, 21231
        • Johns Hopkins Oncology Center
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Massachusetts General Hospital (MGH)
    • New York
      • New York, New York, Forente stater, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Forente stater, 10032
        • Columbia University Medical Center, Milstein Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15232-1305
        • University of Pittsburgh Cancer Institute
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Medical College of Wisconsin

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Gemcitabine-refractory metastatic ductal adenocarcinoma of the pancreas

    • At least 1 measurable lesion according to RECIST 1.1 criteria
    • Computerized tomography (CT) scan ≤ 28 days prior to CO-1.01
    • First-line treatment included at least 3 doses of gemcitabine (as monotherapy or combination therapy) with the last dose administered at least 2 weeks prior to CO 1.01
    • Radiological best response of disease progression after 1st-line treatment (no radiological stable disease or better allowed at any time)
    • Patients who experienced progressive disease during (neo)-adjuvant gemcitabine-based therapy are also eligible
    • Patients who have completed previous adjuvant therapy without progression, then subsequently have a radiological best response of disease progression on 1st line gemcitabine for metastatic disease are eligible
  2. No hENT1 expression in primary or metastatic tumor sample, confirmed with IHC by a core pathology laboratory prior to study entry also eligible
  3. Performance Status (ECOG) 0 or 1
  4. Age ≥18 years
  5. Palliative radiotherapy (if administered) ≥2 weeks prior to CO-1.01
  6. Adequate hematological and biological function, with no residual gemcitabine-related toxicity
  7. Written consent on an Institutional Review Board (IRB)-approved IC Form prior to any study-specific evaluation

Exclusion Criteria:

  1. Patients who have had stable disease, partial response or complete response to first line gemcitabine-based therapy
  2. First-line chemotherapy regimen that does not contain gemcitabine
  3. First-line treatment discontinued due to intolerable gemcitabine-induced toxicity
  4. Second or subsequent line therapy for advanced disease. Prior exposure to CO-1.01 or prior randomization in a protocol studying CO-1.01 (e.g.,Protocol CO-101-001)
  5. Tumor that cannot be evaluated for hENT1 expression or that has hENT1 staining in >50% of cells
  6. Symptomatic brain metastases
  7. Concomitant treatment with prohibited medications (e.g., concurrent anticancer therapy including other chemotherapy, radiation, hormonal treatment [except corticosteroids and megestrol acetate], or immunotherapy) ≤14 days prior to CO-1.01
  8. Exploratory laparotomy, palliative (e.g., bypass) surgery, or other procedures are not allowed <14 days prior to CO-1.01 administration; stenting procedures are permissible at any time prior to dosing; in all cases, the patient must be sufficiently recovered and stable
  9. History of allergy to gemcitabine or eggs
  10. Females who are pregnant or breastfeeding
  11. Refusal to use adequate contraception for fertile patients (females and males during the study and for 6 months after the last dose of CO-1.01)
  12. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, psychiatric disturbance, uncontrolled intercurrent illness including active infection, arterial thrombosis, or symptomatic pulmonary embolism)
  13. Any other reason for which the investigator considers the patient should not participate in the study

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: CO-1.01
Legemiddel: CO-1.01

1250 mg/m2/day administered on Days 1, 8, and 15 in 4-week treatment cycles.

Patients who have SD or better at the Week 8 assessment and who adequately tolerated the first 2 cycles of treatment may continue CO-1.01 at the same or an increased dose (1400 mg/m2) for Cycle 3 and subsequent cycles.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Disease Control Rate (CR, PR, or SD) using RECIST 1.1
Tidsramme: Every 8 weeks until disease progression
Every 8 weeks until disease progression

Sekundære resultatmål

Resultatmål
Tidsramme
Overall Response Rate (ORR)
Tidsramme: Every 8 weeks
Every 8 weeks
CA 19-9 response rate
Tidsramme: Every 4 weeks
Every 4 weeks
Progression-free survival (PFS)
Tidsramme: Every 8 weeks
Every 8 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Tidsramme: Every week
Every week
Overall survival (OS)
Tidsramme: 3, 6, 9, and 12 months
3, 6, 9, and 12 months
Median progression-free survival
Tidsramme: 3, 6, 9, and 12 months
3, 6, 9, and 12 months
Median overall survival
Tidsramme: 3, 6, 9, and 12 months
3, 6, 9, and 12 months
Duration of response
Tidsramme: Every 8 weeks
Every 8 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Clovis Oncology, Inc.

Etterforskere

  • Hovedetterforsker: Eileen O'Reilly, M.D., Memorial Sloan Kettering Cancer Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2011

Primær fullføring (Faktiske)

1. mars 2013

Studiet fullført (Faktiske)

1. mars 2013

Datoer for studieregistrering

Først innsendt

26. oktober 2010

Først innsendt som oppfylte QC-kriteriene

1. november 2010

Først lagt ut (Anslag)

3. november 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. mars 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. mars 2019

Sist bekreftet

1. mars 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CO-101-003

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