- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01616186
Everolimus/Sorafenib or Sunitinib in Patients With Metastatic Renal Cell Carcinoma (RCC)
A Randomized Non-Comparative Multicenter Phase II Study of Everolimus/Sorafenib or Sunitinib in Patients With Metastatic Renal Cell Carcinoma (RCC)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Fase
- Fase 2
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
INCLUSION CRITERIA
- Histologically- or cytologically-confirmed renal cell carcinoma, which is unresectable or metastatic and of any of the following histologies: clear cell, papillary, chromophobic, oncocytic, unclassified, or mixed. A component of clear cell histology must be present. Tumors with pure collecting duct histology are not eligible.
- Cytoreductive nephrectomy is allowed but not required
- Evidence of RECIST-defined measurable disease (lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20mm using conventional techniques or ≥ 10 mm with spiral CT scan)
Male or female at least 18 years old
- Female patients must be either surgically sterile or postmenopausal, or if of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment and agree to use effective barrier contraception during the period of therapy, and for 3 months after the end of treatment/end of participation in the study. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study.
- Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy, and for 3 months after the end of treatment/end of participation in the study.
- The definition of effective contraception will be based on the judgment of the investigator.
- ECOG performance status 0-1
Adequate bone marrow function:
- ANC ≥ 1500/uL
- platelet count ≥ 100,000/uL
- hemoglobin ≥ 9.0 g/dL
Adequate hepatic function:
- Total bilirubin ≤ 1.5 X ULN
- AST (SGOT) ≤ 2.5 X ULN
- ALT (SGPT) ≤ 2.5 X ULN
Adequate renal function as determined by either:
Calculated or measured creatinine clearance ≥ 40 mL/min (for calculated creatinine clearance, Cockroft-Gault equation will be used)
Modified Cockcroft-Gault formula:
((140 - age (yrs)) x (actual weight(kg))) / (72 x serum creatinine(mg/dl))
* Multiply by another factor of 0.85 if female
- Serum creatinine ≤ 1.5 X ULN
- Able to swallow oral medications
- Total fasting serum cholesterol ≤ 300 mg/dL
- Resolution of any pre-existing toxicity from prior therapy to NCI CTCAE V3.0 ≤ grade 1 (with the exception of hypertension, hypothyroidism)
- Signed and dated informed consent document
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- More than 28 days since any prior therapy, including investigational agents and surgical procedures.
EXCLUSION CRITERIA
- Collecting duct renal cell carcinoma is excluded. Transitional cell carcinoma of the renal pelvis is excluded.
- Prior systemic regimens for renal cell carcinoma (neoadjuvant therapy is acceptable as long as it did not include sunitinib, sorafenib, everolimus, or temsirolimus). A prior therapy which was started and stopped after no more than four weeks of therapy will not constitute a prior systemic regimen.
- Prior surgery, radiation therapy, or systemic therapy for renal cell carcinoma within 4 weeks of starting study treatment.
- History of or known brain metastasis, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening CT or MRI scan (evaluation for CNS disease is required to be performed for eligibility).
- Any of the following within 6 months prior to study drug administration: myocardial infarction, unstable or severe angina, coronary or peripheral artery bypass graft, NYHA functional Class II, III, IV congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
- Ejection fraction lower than institutional lower limit of normal by echocardiogram or MUGA.
- Hypertension that is unable to be controlled with medications to a blood pressure of ≤ 150/90.
- Hypothyroidism that is unable to be controlled with medications such that FT4 is outside of normal limits.
- QTc prolongation (QTc interval ≥ 480 msecs) or any other clinically significant ECG abnormalities.
- Known human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related illness (because of the immunosuppressive effects of therapy). Testing for HIV in the absence of a history or symptoms is not required.
- Hepatitis B or C (because of the risk of reactivation). The following serologies are acceptable for enrollment: HBsAg-/anti-HBc-/anti-HBs-; HBsAg-/anti-HBc+/anti-HBs+; HBsAg-/anti-HBc-/anti-HBs+. The following serologies are not acceptable for enrollment: HBsAg+/anti-HBc+(IgM+/-)/anti-HBs-. If the following serologies are obtained, additional testing will be required to ascertain the patient's hepatitis B status: HBsAg-/anti-HBc+/anti-HBs-.
- "Currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered to have a less than 30% risk of relapse.
- Current treatment on another clinical trial.
- Pregnant or breastfeeding.
- Chronic treatment with systemic steroids or other immunosuppressive agent.
- On oral vitamin K antagonist medication (except low dose warfarin) (other anticoagulants are allowed).
- History of malabsorption syndrome, disease significantly affecting gastrointestinal function or major resection of stomach or small bowel that could interfere with absorption, distribution, metabolism, or excretion of study drugs.
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition (including lab abnormalities) that could interfere with subject safety or obtaining informed consent. Examples of such include uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN (Note: optimal glycemic control should be achieved before starting trial therapy), nonhealing wound, severe infection, severe malnutrition, ventricular arrhythmias, active ischemic heart disease, chronic liver or renal disease, or active upper GI tract ulceration.
- Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period. Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Everolimus/Sorafenib
Patients will be stratified by current smoking status (smoker: yes or no0, for each smoking stratum patients will be randomized in a 2:1 ratio
|
(Note: everolimus and sorafenib are typically dosed in 28 day cycles, and sunitinib is typically dosed in 42 day cycles; for the purposes of this protocol to keep timing consistent, a cycle will be defined as 42 days of therapy) |
Comparatore attivo: Sunitinib
|
Starting dose: sunitinib 50 mg daily 4 weeks on, 2 weeks off - taken fasting, no food 1 hour before or 2 hours after dosing (Note: sunitinib is typically dosed in 42 day cycles described above: 28 days treatment, 14 days off. For the purposes of this protocol, to keep timing consistent, a cycle will be defined as 42 days of therapy) |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Objective response
Lasso di tempo: 12-18 weeks
|
Computerized Tomography Scans (CT) done at Screening and every 2 cycles
|
12-18 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Safety: combination of everolimus and sorafenib
Lasso di tempo: 12-18 weeks
|
Safety/Adverse Event (AE) assessments done on Day 1, 21, 42 during Cycle 1 & Day 28 of all subsuquent cycles; assessments include Eastern Oncology Group Conference (ECOG) Performance scale, physical/history, hematology & chemistry labs; other safety data (e.g.
Electrocardiogram [ECG], Multigated Acquisition Scan [MUGA], etc.) will be considered as appropriate
|
12-18 weeks
|
Progression-free Survival (PFS)
Lasso di tempo: 12-18 weeks
|
- PFS will be measured (using RECIST 1.1 criteria) from the start of protocol therapy until the date of the first occurrence of recurrent or progressive disease or death
|
12-18 weeks
|
Time-to-Progression (TTP)
Lasso di tempo: 12-18 weeks
|
- TTP will be measured from the start of protocol therapy until first date that recurrent or progressive disease is documented
|
12-18 weeks
|
Clinical Benefit rate
Lasso di tempo: 12-18 weeks
|
Clinical benefit (defined as objective response+stable disease) will be summarized for each treatment arm by the proportion of patients achieving this outcome with 95% confidence intervals
|
12-18 weeks
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Andrea Harzstark, MD, University of California, San Francisco
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Neoplasie per tipo istologico
- Neoplasie urologiche
- Neoplasie urogenitali
- Neoplasie per sede
- Malattie renali
- Malattie urologiche
- Adenocarcinoma
- Neoplasie, ghiandolari ed epiteliali
- Neoplasie renali
- Neoplasie
- Carcinoma, cellule renali
- Carcinoma
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Inibitori dell'angiogenesi
- Agenti di modulazione dell'angiogenesi
- Sostanze per la crescita
- Inibitori della crescita
- Inibitori della chinasi proteica
- Sorafenib
- Sunitinib
- Everolimo
Altri numeri di identificazione dello studio
- UCSF CC# 12521
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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