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

5. marts 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

19

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CO-1.01
Medicin: 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.

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Clovis Oncology, Inc.

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2011

Primær færdiggørelse (Faktiske)

1. marts 2013

Studieafslutning (Faktiske)

1. marts 2013

Datoer for studieregistrering

Først indsendt

26. oktober 2010

Først indsendt, der opfyldte QC-kriterier

1. november 2010

Først opslået (Skøn)

3. november 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CO-101-003

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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