- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02648425
Safety and Tolerability of ASLAN001 in Combination With Cisplatin and 5-FU or Cisplatin and Capecitabine
Phase I Study to Evaluate the Safety and Tolerability of ASLAN001 in Combination With Cisplatin and 5-Fluorouracil or Cisplatin and Capecitabine
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
This is an open-label, Phase I, dose escalation study of ASLAN001 given in combination with Regimen A or Regimen B, in patients with metastatic solid tumors, eligible to receive the cisplatin/5-fluorouracil or cisplatin/capecitabine regimen.
Dose of ASLAN001 starts from 400mg BID; then, dose escalation to 500mg BID or dose de-escalation to 300mg BID will depend on DLTs observed in cohort.
Regimen A: Depends on preferred medical practice, Cohort 1A will receive ASLAN001 400 mg BID in combination with cisplatin 80 mg/m2 IV infusion and 5 fluorouracil 800 mg/m2/day IV infusion for 5 days every 3 weeks; or will receive ASLAN001 400 mg BID in combination with Cisplatin 35 mg/m2 24-hour infusion for day 1 and day 8, 5-fluorouracil 2,000 mg/m2 and Leucovorin 300mg/m2 24-hour infusion for day 1, day 8 and day 15 every 4 weeks.
Regimen B: Cohort 1B will receive ASLAN001 400 mg BID in combination with cisplatin 80 mg/m2 IV infusion and oral capecitabine 1,000 mg/m2 BID for 14 days every 3 weeks.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 1
Kontakty i lokalizacje
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Male or female patients 20 years of age or older at the time written informed consent is obtained.
Regimen A: Patients with metastatic solid tumors eligible for treatment with cisplatin and 5-fluorouracil. The standard dose and schedule of cisplatin and 5-fluorouracil will be according to the preference of investigators and institutions.
Regimen B: Patients with metastatic solid tumors eligible for treatment with cisplatin in combination with capecitabine.
- Patients with a partial gastrectomy may be allowed to participate in the study as long as they can take oral medications and meet all other inclusion/exclusion criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ and hematological function as evidenced by the following laboratory studies within 14 days prior to enrolment:
Hematological function, as follows:
- Absolute neutrophil count ≥ 1.5 x 109/L.
- Platelet count ≥ 100 x 109/L.
- Hemoglobin ≥ 9 g/dL.
Coagulation function, as follows:
- Partial thromboplastin time or activated partial thromboplastin time ≤ 1.5 x upper limit of normal (ULN) per institutional laboratory normal range.
- International normalized ratio ≤ 1.5.
Renal function, as follows:
• Creatinine clearance ≥ 50 mL/min as calculated by Cockcroft-Gault formula.
Hepatic function, as follows:
- Total bilirubin ≤ 1.5 x ULN.
- AST and ALT ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases are present).
Exclusion Criteria:
- Patients with persistent gastric outlet obstruction, complete dysphagia or feeding jejunostomy.
- Patients receiving proton pump inhibitors or H2 antagonists for established, symptomatic gastro duodenal ulceration or gastroesophageal reflux disease.
- Patients with unresolved toxicities of grade 2 or more from prior anti-cancer therapies.
- Untreated or symptomatic central nervous system metastases. Patients with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastases, and the patient is clinically stable and is off corticosteroids for at least 2 weeks prior to enrolment.
- Major surgical procedures within 28 days prior to enrolment.
- Clinically significant cardiovascular diseases that are symptomatic or uncontrolled.
- Known positive test for human immunodeficiency virus, hepatitis C, or hepatitis B surface antigen.
- Pregnant or breast-feeding females.
- Patients who have hearing impairment, due to the potential for ototoxicity of cisplatin.
- Any history or presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease or any other condition which in the opinion of the Investigator could jeopardize the safety of the patient or the validity of the study results
Plan studiów
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 |
---|---|
Eksperymentalny: Regimen A / Amended Regimen A
Regimen A: Cisplatin + 5-fluorouracil ASLAN001 daily in combination with: Cisplatin 80 mg/m2 IV infusion for 1 day and 5-fluorouracil 800 mg/m2/day IV infusion for 5 days every 3 weeks for up to 6 cycles. Or Amended Regimen A: Cisplatin + 5-fluorouracil + leucovorin ASLAN001 daily in combination with: Cisplatin 35 mg/m2 24-hour infusion for day 1 and day 8, 5-fluorouracil 2,000 mg/m2 and Leucovorin 300mg/m2 24-hour infusion for day 1, day 8 and day 15 every 4 weeks for up to 6 cycles. |
ASLAN001 400mg BID daily; ASLAN001 500mg BID daily; or ASLAN001 300mg BID daily
Inne nazwy:
Cisplatin 80 mg/m2 IV infusion and 5-fluorouracil 800 mg/m2/day IV infusion for 5 days every 3 weeks; Or Cisplatin 35 mg/m2 24-hour infusion for day 1 and day 8, 5-fluorouracil 2,000 mg/m2 and Leucovorin 300mg/m2 24-hour infusion for day 1, day 8 and day 15 every 4 weeks. |
Eksperymentalny: Regimen B
Regimen B: Cisplatin + capecitabine ASLAN001 daily in combination with: Cisplatin 60-80 mg/m2 IV infusion on Day 1 and capecitabine 1,000 mg/m2 orally BID for 14 days every 3 weeks for up to 6 cycles. |
ASLAN001 400mg BID daily; ASLAN001 500mg BID daily; or ASLAN001 300mg BID daily
Inne nazwy:
Cisplatin 80 mg/m2 IV infusion and capecitabine 1,000 mg/m2 orally BID for 14 days every 3 weeks
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Safety and Tolerability of ASALN001
Ramy czasowe: First 2 cycles
|
Safety and tolerability as evaluated with: DLTs (in first 2 cycles); Maximum tolerated dose (MTD) of ASLAN001 in combination with cisplatin/capecitabine or cisplatin/5-FU will be determined. |
First 2 cycles
|
Safety and Tolerability of ASALN001
Ramy czasowe: Baseline to post-dose
|
Safety and tolerability as evaluated with: Adverse events. |
Baseline to post-dose
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Preliminary assessment of the efficacy
Ramy czasowe: Along the study duration
|
•To provide a preliminary assessment of the efficacy of ASLAN001 when given in combination in Regimen A or Regimen B as measured by the objective response rate (ORR).
|
Along the study duration
|
Pharmacokinetics profile (AUC) of ASLAN001
Ramy czasowe: Along the study duration
|
To evaluate the pharmacokinetics of ASLAN001, when given in combination with Regimen A or Regimen B. Pharmacokinetic parameters including, but not limited to area under the plasma concentration-time curve (AUC) from 0 to 6 hours (AUC0-6).
|
Along the study duration
|
Pharmacokinetics profile (Cmax) of ASLAN001
Ramy czasowe: Along the study duration
|
To evaluate the pharmacokinetics of ASLAN001, when given in combination with Regimen A or Regimen B. Pharmacokinetic parameters including, but not limited to maximum plasma concentration (Cmax).
|
Along the study duration
|
Pharmacokinetics profile (Cmin) of ASLAN001
Ramy czasowe: Along the study duration
|
To evaluate the pharmacokinetics of ASLAN001, when given in combination with Regimen A or Regimen B. Pharmacokinetic parameters including, but not limited to minimum (trough) plasma concentration (Cmin).
|
Along the study duration
|
Pharmacokinetics profile (RacAUC0-6) of ASLAN001
Ramy czasowe: Pharmacokinetic measurements will be from Cycle 1 Day 1 to Cycle 3 Day 1 (each cycle is 28 days for Amended Regimen A, and 21 days for Regimen A and B.
|
To evaluate the pharmacokinetics of ASLAN001, when given in combination with Regimen A or Regimen B. Pharmacokinetic parameters including, but not limited to accumulation ratio for AUC (RacAUC0-6).
|
Pharmacokinetic measurements will be from Cycle 1 Day 1 to Cycle 3 Day 1 (each cycle is 28 days for Amended Regimen A, and 21 days for Regimen A and B.
|
Pharmacokinetics profile (Tmax) of ASLAN001
Ramy czasowe: Along the study duration
|
To evaluate the pharmacokinetics of ASLAN001, when given in combination with
|
Along the study duration
|
Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: ASLAN Pharma, ASLAN Pharmaceuticals
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Fizjologiczne skutki leków
- Molekularne mechanizmy działania farmakologicznego
- Antymetabolity, przeciwnowotworowe
- Antymetabolity
- Środki przeciwnowotworowe
- Środki immunosupresyjne
- Czynniki immunologiczne
- Środki ochronne
- Mikroelementy
- Witaminy
- Odtrutki
- Kompleks witamin B
- Cisplatyna
- Fluorouracyl
- Kapecytabina
- Leukoworyna
Inne numery identyfikacyjne badania
- ASLAN001-002
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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Badania kliniczne na ASLAN001
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National Cancer Centre, SingaporeNational Medical Research Council (NMRC), Singapore; ASLAN PharmaceuticalsAktywny, nie rekrutujący
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