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RAD001 in Advanced Hepatocellular Carcinoma

14 december 2016 uppdaterad av: Andrew X. Zhu, MD, Massachusetts General Hospital

A Phase I/II Study of RAD001 in Advanced Hepatocellular Carcinoma

Laboratory studies have shown that RAD001 can prevent cells from multiplying. Consequently, the study drug is being tested in medical conditions in which excessive cell multiplication (as in cancer) needs to be stopped. The main purpose of this research study is to find the highest dose of RAD001 that can be given safely (without causing severe side effects) and to learn the effects (good or bad) RAD001 has on participants with liver cancer.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

  • Participants will be given a supply of the study drug RAD001 to be taken at home. They will be asked to take the study drug every morning on an empty stomach and will be given a study drug diary to record the time/date each time they take RAD001. Each 6 week period of time is called a cycle of study treatment.
  • We are looking for the highest dose of RAD001 that can be given safely. Therefore not every participant will receive the same dose of RAD001.
  • Participants will come to the clinic every other week. At each of these visits, a physical examination and blood tests will be performed.
  • A CT and MRI will be repeated every 6 weeks during the first 3 cycles of treatment then every 12 weeks thereafter.

Studietyp

Interventionell

Inskrivning (Faktisk)

28

Fas

  • Fas 2
  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Förenta staterna, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, Förenta staterna, 02114
        • Massachusetts General Hospital

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

Allt

Beskrivning

Inclusion Criteria:

  • Unresectable of metastatic HCC. Patients must have prior core biopsy to confirm the diagnosis of HCC and have archived tissues available for correlative studies
  • At least one measurable site of disease according to RECIST criteria that has not been previously irradiated. If it has had previous radiation to teh marker lesion(s), there must be evidence of progression since the radiation
  • 0-2 prior systemic chemotherapy and biologic regimens for hepatocellular carcinoma
  • Patients with prior chemoembolization history can participate in the study if the chemoembolization was performed more than 4 weeks ago and patients must have measurable disease outside of prior chemoembolization field
  • 18 years of age or older
  • Minimum of 4 weeks since any major surgery or completion of radiation
  • Minimum of 4 weeks since completion of all prior systemic anticancer therapy
  • ECOG performance status of 0-2
  • CLIP score of equal to or less then 3
  • Adequate bone marrow, liver and renal function as outlined in the protocol

Exclusion Criteria:

  • Prior treatment with any investigational drug within the preceding 4 weeks
  • Chronic treatment with systemic steroids or another immunosuppressive agent
  • Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
  • Patients with any severe and/or uncontrolled medical conditions or other condition that could affect participation in the study
  • Known history of HIV seropositivity
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001
  • Active, bleeding diathesis
  • Women who are pregnant or breast feeding
  • Patients who have received prior treatment with an mTor inhibitor
  • Patients with known hypersensitivity to RAD001 or other rapamycins or its excipients
  • History of non-compliance to medical regimens
  • Patients with a positive dipstick for urine protein (reading of 2+ or greater) will then undergo a 24-hour urine collection for protein. If patients have a 2g or greater of protein/24hr, they will be excluded from the study.

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: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: RAD001
Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.
Läkemedel: RAD001
Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days
Andra namn:
  • Everolimus

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Maximum Tolerated Dose of RAD001 in Patients With Advanced Hepatocellular Carcinoma (HCC).
Tidsram: 2 years
2 years
Progression-free Survival Rate at 24 Weeks
Tidsram: 2 years

Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"

This information will be collected during two years of patient participation.
2 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Patients With Adverse Events Who Were Treated With RAD001 for Advanced HCC
Tidsram: 2 years
Everolimus given at 10 mg/day as a single agent was well tolerated in patients with advanced HCC.
2 years
Overall Response Rate
Tidsram: 2 years
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
2 years
Time to Progression
Tidsram: 2 years
3.9 months with a CI of 21-
2 years
Overall Survival
Tidsram: 2 years
The median overall survival was 8.4 months (95% CI, 3.9-21.1 months). Only 2 ((8 %) patients were progression-free at 24 weeks. The study did not proceed to the second stage of the phase 2 portion of the study.
2 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Massachusetts General Hospital

Samarbetspartners

Novartis
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center

Utredare

  • Huvudutredare: Andrew X. Zhu, MD, PhD, Massachusetts General Hospital

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.

Allmänna publikationer

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 2007

Primärt slutförande (Faktisk)

1 januari 2010

Avslutad studie (Faktisk)

1 november 2011

Studieregistreringsdatum

Först inskickad

13 augusti 2007

Först inskickad som uppfyllde QC-kriterierna

13 augusti 2007

Första postat (Uppskatta)

15 augusti 2007

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

7 februari 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 december 2016

Senast verifierad

1 december 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 06-352

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

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