- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00122343
AP23573 in Female Adult Patients With Recurrent or Persistent Endometrial Cancer (8669-019)(COMPLETED)
18 februari 2015 uppdaterad av: Merck Sharp & Dohme LLC
A Phase II Study of AP23573, an mTOR Inhibitor, in Female Adult Patients With Recurrent or Persistent Endometrial Cancer
This is an open-label nonrandomized multi-center study designed to evaluate the effect of AP23573 in patients with recurrent or persistent endometrial cancer.
The primary objective is to assess the efficacy of AP23573 in patients with recurrent or persistent endometrial cancer when administered once daily for 5 consecutive days (QDx5) every two weeks at a dose of 12.5 mg/day.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
45
Fas
- Fas 2
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
Inclusion Criteria:
- ≥18 years of age with histologically confirmed endometrial cancer
- Documented progression of endometrial cancer (e.g., within the last 3 months)
- If of childbearing potential, must agree to use approved barrier methods of contraception (non hormonal methods)
- Presence of at least one measurable lesion that can be accurately measured in at least one dimension with longest diameter ≥20 mm using conventional techniques or ≥10 mm with spiral computed tomography (CT) scan (or otherwise at least twice the reconstruction interval for CT or magnetic resonance imaging [MRI] scans). Previously irradiated lesions may be considered to be measurable provided: *there has been documented progression of the lesion(s) since completion of radiotherapy; and *the criteria for measurability as outlined above are met.
- ECOG performance status ≤ 2
- Minimum life expectancy of 3 months
Adequate renal and hepatic function, defined as:
- Total serum bilirubin ≤ 1.5 x ULN for the institution;
- AST and/or ALT ≤ 2 x ULN for the institution;
- Alkaline phosphatase < 1.5 x ULN for the institution (if > 1.5 x ULN, then alkaline phosphatase liver fraction must be < 1.5 ULN);
- Serum albumin ≥ 2.5 g/dL;
- Serum creatinine ≤ 1.5 x ULN for the institution.
Adequate bone marrow function, defined as:
- ANC ≥ 1.5 x 10^9/L;
- Platelet count ≥ 100 x 10^9/L.
- Serum cholesterol <350 mg/dL and triglycerides < 400 mg/dL
- Able to understand and give written informed consent
Exclusion Criteria:
- Women who are pregnant or lactating
- Presence of brain metastases
- More than 2 prior regimens of cytotoxic chemotherapy or enzyme inhibitor therapy
- Prior therapy with rapamycin, rapamycin analogues or tacrolimus; or known sensitivity to these agents
- Anticancer treatment (chemotherapy, radiotherapy, immunotherapy, biological response modifiers, signal transduction inhibitors, etc.) within 4 weeks prior to the first dose of AP23573. The interval may be ≥ 2 weeks for hormonal therapy or signal transduction inhibitors with a half-life known to be <24 hours and must be ≥ 6 weeks for nitrosourea or mitomycin.
- Ongoing toxicity associated with prior anticancer therapy (except peripheral neuropathy of ≤ Grade 1 by National Cancer Institute [NCI] toxicity criteria)
- Another primary malignancy within the past three years (except for non-melanoma skin cancer and cervical carcinoma in situ)
- Known or suspected hypersensitivity to drugs formulated with polysorbate 80 (Tween) or any other excipient contained in the study drug
- Known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin)
- Significant uncontrolled cardiovascular disease
- Active infection requiring systemic therapy
- Known HIV infection
- Treatment with any investigational agent within 4 weeks prior to the first dose of AP23573
- Concurrent treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for ≥ 2 weeks prior to first planned dose of study drug. Nasal, ophthalmic, and topical glucocorticoid preparations are allowed as well as low dose maintenance steroid therapy for other conditions. Physiologic hormone replacement therapy (e.g., thyroid supplementation for thyroid deficiency or oral replacement glucocorticoid therapy for adrenal insufficiency) is allowed.
- Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to the first dose of AP23573. Patients who have recovered from placement of a central venous access port within 2 weeks of Cycle 1, Day 1 will be considered eligible.
- Presence of any other life-threatening illness or organ system dysfunction which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluating the safety of the study drug
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 1
AP23573 will be administered intravenously (IV) at a fixed dose of 12.5 mg over 30 minutes once daily for 5 days (QDx5) every 2 weeks.
A 4-week period comprised of 2 courses of AP23573 is defined as a cycle of treatment.
|
AP23573 will be administered intravenously (IV) at a fixed dose of 12.5 mg over 30 minutes once daily for 5 days (QDx5) every 2 weeks.
A 4-week period comprised of 2 courses of AP23573 is defined as a cycle of treatment.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
The primary objective of the study is to assess the efficacy of AP23573 in patients with recurrent or persistent endometrial cancer when administered once daily for 5 consecutive days (QDx5) every two weeks at a dose of 12.5 mg/day.
Tidsram: Duration of the study
|
Duration of the study
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Assess the safety and tolerability of this study drug regimen in this patient population
Tidsram: Duration of the study
|
Duration of the study
|
Evaluate secondary efficacy endpoints of time to tumor progression, progression-free survival and duration of response
Tidsram: Duration of the study
|
Duration of the study
|
Examine pharmacokinetic characteristics of AP23573
Tidsram: Duration of the study
|
Duration of the study
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studiestol: Frank Haluska, M.D., Ph.D., Ariad Pharmaceuticals
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2005
Primärt slutförande (Faktisk)
1 januari 2008
Avslutad studie (Faktisk)
1 januari 2008
Studieregistreringsdatum
Först inskickad
21 juli 2005
Först inskickad som uppfyllde QC-kriterierna
21 juli 2005
Första postat (Uppskatta)
22 juli 2005
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
19 februari 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 februari 2015
Senast verifierad
1 februari 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Uterina neoplasmer
- Genitala neoplasmer, hona
- Livmodersjukdomar
- Endometriella neoplasmer
- Läkemedels fysiologiska effekter
- Anti-infektionsmedel
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Antibakteriella medel
- Antibiotika, antineoplastiska
- Antifungala medel
- Sirolimus
Andra studie-ID-nummer
- 8669-019
- AP23573-04-203
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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