Study to Evaluate Efficacy of CO-1.01 as Second Line Therapy for Gemcitabine-Refractory Stage IV Pancreatic Adenocarcinoma
5 mars 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
19
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Arizona
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Tucson, Arizona, États-Unis, 85724
- Arizona Cancer Center at University of Arizona
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Colorado
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Denver, Colorado, États-Unis, 80218
- Rocky Mountain Cancer Center
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Florida
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Boynton Beach, Florida, États-Unis, 33425
- Palm Beach Institute / Collaborative Research Group
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Miami, Florida, États-Unis, 33136
- University of Miami
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Georgia
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Atlanta, Georgia, États-Unis, 30309
- Piedmont Healthcare Research Institute (PHRI)
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Kentucky
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Louisville, Kentucky, États-Unis, 40202
- Norton Cancer Institute Research Program
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Maryland
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Baltimore, Maryland, États-Unis, 21231
- Johns Hopkins Oncology Center
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital (MGH)
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New York
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New York, New York, États-Unis, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, États-Unis, 10032
- Columbia University Medical Center, Milstein Hospital
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73104
- University of Oklahoma Health Sciences Center
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Pennsylvania
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Pittsburgh, Pennsylvania, États-Unis, 15232-1305
- University of Pittsburgh Cancer Institute
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Wisconsin
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Milwaukee, Wisconsin, États-Unis, 53226
- Medical College of Wisconsin
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
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
- No hENT1 expression in primary or metastatic tumor sample, confirmed with IHC by a core pathology laboratory prior to study entry also eligible
- Performance Status (ECOG) 0 or 1
- Age ≥18 years
- Palliative radiotherapy (if administered) ≥2 weeks prior to CO-1.01
- Adequate hematological and biological function, with no residual gemcitabine-related toxicity
- Written consent on an Institutional Review Board (IRB)-approved IC Form prior to any study-specific evaluation
Exclusion Criteria:
- Patients who have had stable disease, partial response or complete response to first line gemcitabine-based therapy
- First-line chemotherapy regimen that does not contain gemcitabine
- First-line treatment discontinued due to intolerable gemcitabine-induced toxicity
- 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)
- Tumor that cannot be evaluated for hENT1 expression or that has hENT1 staining in >50% of cells
- Symptomatic brain metastases
- 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
- 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
- History of allergy to gemcitabine or eggs
- Females who are pregnant or breastfeeding
- 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)
- 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)
- Any other reason for which the investigator considers the patient should not participate in the study
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: CO-1.01
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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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Disease Control Rate (CR, PR, or SD) using RECIST 1.1
Délai: Every 8 weeks until disease progression
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Every 8 weeks until disease progression
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Overall Response Rate (ORR)
Délai: Every 8 weeks
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Every 8 weeks
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CA 19-9 response rate
Délai: Every 4 weeks
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Every 4 weeks
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Progression-free survival (PFS)
Délai: Every 8 weeks
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Every 8 weeks
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Délai: Every week
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Every week
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Overall survival (OS)
Délai: 3, 6, 9, and 12 months
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3, 6, 9, and 12 months
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Median progression-free survival
Délai: 3, 6, 9, and 12 months
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3, 6, 9, and 12 months
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Median overall survival
Délai: 3, 6, 9, and 12 months
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3, 6, 9, and 12 months
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Duration of response
Délai: Every 8 weeks
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Every 8 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Eileen O'Reilly, M.D., Memorial Sloan Kettering Cancer Center
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2011
Achèvement primaire (Réel)
1 mars 2013
Achèvement de l'étude (Réel)
1 mars 2013
Dates d'inscription aux études
Première soumission
26 octobre 2010
Première soumission répondant aux critères de contrôle qualité
1 novembre 2010
Première publication (Estimation)
3 novembre 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 mars 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 mars 2019
Dernière vérification
1 mars 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CO-101-003
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .