An Open-Label, Dose-Escalation Study of IMC-20D7S In Participants With Malignant Melanoma
11 marca 2019 zaktualizowane przez: Eli Lilly and Company
An Open-Label, Dose-Escalation Phase 1/1b Study of the Anti-gp75 Monoclonal Antibody IMC-20D7S In Patients With Malignant Melanoma Who Have Progressed After or During at Least One Treatment With Standard Cytotoxic Treatment or/and Immunotherapy Therapy or For Whom Standard Therapy is Not Indicated
A dose-escalation study designed to determine the safety, maximum tolerated dose (MTD), anti-melanoma activity, antibody blood levels and progression-free survival (PFS) in participants with malignant melanoma receiving IMC-20D7S either every 2 weeks or every 3 weeks.
Przegląd badań
Status
Zakończony
Warunki
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
27
Faza
- Faza 1
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02114
- ImClone Investigational Site
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New York
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New York, New York, Stany Zjednoczone, 10021
- ImClone Investigational Site
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Participant has histologically or cytologically confirmed cutaneous, mucosal, or uveal malignant melanoma which has progressed after or during at least 1 treatment with standard cytotoxic treatment or/and immunotherapy [for example (e.g.), treatment with cytokines, monoclonal antibodies, and vaccines] and is not regarded to be a candidate for a potentially curative, higher priority treatment for melanoma
- Participant is ≥18 years of age
- Participant has either measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or evaluable disease
- At least 21 days must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy. Relative to participant's treatment with non-approved biological products (eg, monoclonal antibodies), a minimum of 2 half-lives must have passed for eligibility to be considered
- Participant has resolution of all clinically significant toxic effects of prior cancer therapy to Grade ≤1 according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.02 (NCI-CTCAE v4.02)
- Participant has adequate hematological function, hepatic function, and renal function
Exclusion Criteria:
- Participant has undergone major surgery [e.g., laparotomy, thoracotomy, removal of organ(s)] within 21 days prior to study entry
- Participant has elective or planned surgery to be conducted during the trial
- Participant has documented and/or symptomatic brain or leptomeningeal metastases
- Participant is receiving systemic steroids or other immunosuppressive medications. (Intermittent use of steroid-containing medications e.g., for asthma exacerbation or for skin lesions is permitted)
- Participant has an uncontrolled undercurrent illness
- Participant has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive carcinoma or in situ neoplasm
- Participant has a known allergy to any of the treatment components (monoclonal antibodies or other therapeutic proteins such as fresh frozen plasma, human serum albumin, cytokines, or interleukins). In the event that there is suspicion the participant may have allergies, the participant should be excluded
- Participant is pregnant or lactating
- Participant has known human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) infection
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: IMC-20D7S (1A-4A Cohorts)
Escalating doses up to 30 milligrams per kilogram (mg/kg) administered intravenously (i.v.) every 2 weeks; includes Cohorts 1A, 2A, 3A, and 4A.
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5 mg/kg i.v. every 2 weeks. Administered every other week on Days 1 and 15 of each treatment cycle. If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants, then enrollment into Cohort 2A.
Inne nazwy:
10 mg/kg i.v. every 2 weeks. Administered every other week on Days 1 and 15 of each treatment cycle. If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2A, then enrollment into Cohort 3A.
Inne nazwy:
20 mg/kg i.v. every 2 weeks. Administered every other week on Days 1 and 15 of each treatment cycle. If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 3A, then enrollment into Cohort 4A.
Inne nazwy:
30 mg/kg i.v. every 2 weeks. Administered every other week on Days 1 and 15 of each treatment cycle.
Inne nazwy:
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Eksperymentalny: IMC-20D7S (1B-3B Cohorts)
Escalating doses up to 30 mg/kg administered i.v.
every 3 weeks; includes Cohorts 1B, 2B, and 3B.
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10 mg/kg i.v. every 3 weeks. Administered every 3 weeks on Days 1 and 22 of each treatment cycle. If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants in Cohort 1B, then enrollment into Cohort 2B.
Inne nazwy:
20 mg/kg i.v. every 3 weeks. Administered every 3 weeks on Days 1 and 22 of each treatment cycle. If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2B, then enrollment into Cohort 3B.
Inne nazwy:
30 mg/kg i.v. every 3 weeks. Administered every 3 weeks on Days 1 and 22 of each treatment cycle.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Maximum Tolerated Dose (MTD) of IMC-20D7S
Ramy czasowe: Baseline to toxicity [up to end of Cycle 1 (4 or 6-week cycles)]
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The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT) during treatment Cycle 1.
A DLT was defined as any Grade 3 or above toxicity that emerged during study treatment and was clearly not attributable to malignant melanoma or co-medication and was possibly, probably, or definitely related to IMC-20D7S in the judgment of the investigator.
No DLT was observed in the study; a provisional MTD was established.
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Baseline to toxicity [up to end of Cycle 1 (4 or 6-week cycles)]
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Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death
Ramy czasowe: Baseline through 30 days post last dose (up to 31 weeks)
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A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
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Baseline through 30 days post last dose (up to 31 weeks)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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IMC-20D7S Pharmacokinetics (PK): Maximum Concentration (Cmax)
Ramy czasowe: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 hours (h) post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
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A non-validated assay was used to determine individual serum concentrations of IMC-20D7S.
Thus, analyses of PK data were not conducted.
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Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 hours (h) post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
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IMC-20D7S PK: Minimal Concentration (Cmin)
Ramy czasowe: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
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A non-validated assay was used to determine individual serum concentrations of IMC-20D7S.
Thus, analyses of PK data were not conducted.
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Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
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IMC-20D7S PK: Half-life (t½)
Ramy czasowe: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
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A non-validated assay was used to determine individual serum concentrations of IMC-20D7S.
Thus, analyses of PK data were not conducted.
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Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
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IMC-20D7S PK: Clearance (Cl)
Ramy czasowe: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
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A non-validated assay was used to determine individual serum concentrations of IMC-20D7S.
Thus, analyses of PK data were not conducted.
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Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
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IMC-20D7S PK: Area Under the Concentration Versus Time Curve (AUC)
Ramy czasowe: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
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A non-validated assay was used to determine individual serum concentrations of IMC-20D7S.
Thus, analyses of PK data were not conducted.
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Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
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IMC-20D7S PK: Volume of Distribution (Vd) at Steady State
Ramy czasowe: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
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A non-validated assay was used to determine individual serum concentrations of IMC-20D7S.
Thus, analyses of PK data were not conducted.
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Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
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Number of Participants Who Develop Antibodies Against IMC-20D7S (Immunogenicity)
Ramy czasowe: Prior to the first and second infusion in each cycle up to Cycle 7 (4- and 6-week cycles)
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Planned analyses for immunogenicity were not completed.
A decision was made not to develop a validated immunogenicity assay because of the exploratory nature of the study and the analyses.
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Prior to the first and second infusion in each cycle up to Cycle 7 (4- and 6-week cycles)
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Progression-Free Survival (PFS)
Ramy czasowe: First dose to disease progression or death (up to 27 weeks)
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PFS was determined for participants who went beyond their first disease assessment and completed at least 1 treatment beyond Week 1 of treatment Cycle 3.
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First dose to disease progression or death (up to 27 weeks)
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Recommend Doses for Phase 2/3 Studies Based on MTD
Ramy czasowe: Baseline to toxicity [up to end of Cycle 1 (4-or 6-week cycles)]
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It was decided for administrative reasons to discontinue dosing at the provisional MTD rather than progress to Phase 1b.
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Baseline to toxicity [up to end of Cycle 1 (4-or 6-week cycles)]
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Dyrektor Studium: E-mail: ClinicalTrials@ ImClone.com, Eli Lilly and Company
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 czerwca 2010
Zakończenie podstawowe (Rzeczywisty)
1 sierpnia 2012
Ukończenie studiów (Rzeczywisty)
1 sierpnia 2012
Daty rejestracji na studia
Pierwszy przesłany
2 czerwca 2010
Pierwszy przesłany, który spełnia kryteria kontroli jakości
3 czerwca 2010
Pierwszy wysłany (Oszacować)
4 czerwca 2010
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
17 czerwca 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
11 marca 2019
Ostatnia weryfikacja
1 marca 2019
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 13945
- CP22-0901 (Inny identyfikator: ImClone, LLC)
- I4Z-IE-JDEA (Inny identyfikator: Eli Lilly and Company)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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