- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT01115751
A Study in Patients With Advanced or Metastatic Cancer
A Phase I Trial of Single-Agent LY2780301 in Patients With Advanced or Metastatic Cancer
A tanulmány áttekintése
Részletes leírás
JWAA will consist of the following treatment phases parts:
Part A - Dose escalation phase using a once-daily dosing schedule. Part B - Dose escalation phase using a twice-daily dosing schedule. Part C - Dose expansion phase using the maximum tolerated dose from either Part A or Part B.
Tanulmány típusa
Beiratkozás (Várható)
Fázis
- 1. fázis
Kapcsolatok és helyek
Tanulmányi helyek
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Barcelona, Spanyolország
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Madrid, Spanyolország
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic (including Non-Hodgkin's Lymphoma). The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their disease.
- Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or the Revised Response Criteria for Malignant Lymphoma.
Parts A and B: have measurable or nonmeasurable disease. Part C: have measurable disease.
Have adequate organ function, including:
- Hematologic: Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L, platelets greater than or equal to 100 x 109/L, and hemoglobin greater than or equal to 8 g/dL. Transfusions are not allowed to reach 8 g/dL prior to enrollment.
- Hepatic: Bilirubin less than or equal to 1.5 times upper limits of normal (ULN), alanine aminotransaminase (ALT), and aspartate aminotransaminase (AST) less than or equal to 2.5 times ULN. If the liver has tumor involvement, AST and ALT equaling less than or equal to 5 times ULN are acceptable.
- Renal: Serum creatinine less than or equal to 1.5 times ULN or calculated creatinine clearance greater than 45 ml/mn.
- Have a performance status of less than or equal to 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Have discontinued previous treatments for cancer and recovered from the acute effects of therapy: at least 28 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents. At the discretion of the investigator, hormone-refractory prostate cancer patients who are stable on gonadotropin-releasing hormone (GnRH) agonist therapy may have that treatment continued while they are enrolled in this study.
Exclusion Criteria:
- Have received treatment within 28 days of the initial dose of study drug with an experimental agent for noncancer indications that has not received regulatory approval for any indication.
- Have serious preexisting medical conditions (left to the discretion of the investigator).
- Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required). Patients with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic and radiographically stable for at least 60 days.
- Have current acute or chronic leukemia.
- Have an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
- Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results.
- Have QTc interval of >470 msec on screening electrocardiogram(ECG).
- Treatment with a strong CYP3A4 substrate with narrow therapeutic range, strong inhibitor, or inducer.
- Have history of pituitary adenoma.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: LY2780301
Part A: daily dosing Part B (if determined as needed by pharmacokinetic, pharmacodynamic, and safety data): twice daily dosing Part C: Dose and frequency as determined by Parts A and B of the study. |
Administered orally, daily for two 28-day cycles. Starting dose is 100mg. The dose will be subsequently increased to 200mg, 300mg, 400mg, 500mg, and 600mg if no dose limiting toxicity is observed at the prior dose levels. Patients who, in the opinion of the investigator, demonstrate clinical benefit may receive treatment beyond two cycles until disease progression. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Időkeret |
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Recommended dose for Phase 2 Studies
Időkeret: Baseline to study completion
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Baseline to study completion
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Másodlagos eredményintézkedések
Eredménymérő |
Időkeret |
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Clinically significant effects
Időkeret: Baseline to study completion
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Baseline to study completion
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Pharmacokinetics, area under the concentration-time curve
Időkeret: Baseline, Days 1, 2, 8, 15, and 22 of Cycle 1, Day 1 of Cycle 2
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Baseline, Days 1, 2, 8, 15, and 22 of Cycle 1, Day 1 of Cycle 2
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Best overall response (CR+PR+SD)
Időkeret: Baseline to measured disease progression. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.
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Baseline to measured disease progression. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.
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Progression-free survival
Időkeret: Baseline to measured disease progression or death. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.
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Baseline to measured disease progression or death. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.
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Duration of response
Időkeret: Time of response to disease progression or death. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.
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Time of response to disease progression or death. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.
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Pharmacokinetics, maximum concentration (Cmax)
Időkeret: Baseline, Days 1, 2, 8, 15, and 22 of Cycle 1, Day 1 of Cycle 2
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Baseline, Days 1, 2, 8, 15, and 22 of Cycle 1, Day 1 of Cycle 2
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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 13127
- I4H-MC-JWAA (Egyéb azonosító: Eli Lilly and Company)
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Klinikai vizsgálatok a LY2780301
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Institut Paoli-CalmettesMegszűnt
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Gustave Roussy, Cancer Campus, Grand ParisBefejezveSzilárd daganatok és non-Hodgkin limfómaFranciaország