Daha Önce Hedefe Yönelik Tedavi ve Kemoterapiye Yanıt Vermemiş Metastatik Kolorektal Kanser Hastalarında Everolimus'un Etkililiği ve Güvenliliği

Sade dilde özet

Bu çalışma, daha önceki hedefe yönelik tedavi ve kemoterapiye yanıt vermemiş, vücuda yayılmış (metastatik) kolorektal kanser (colorectal cancer) hastalarında Everolimus (RAD001) ilacının etkililiğini ve güvenliliğini incelemektedir. Çalışmaya, 18 yaş ve üzeri, metastatik kalın bağırsak kanseri olan ve son 6 ay içinde hastalığı ilerlemiş hastalar katılabilmiştir. Novartis Pharmaceuticals tarafından yürütülen çalışma Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Tamamlandı

Sponsor

Novartis Pharmaceuticals

Müdahale

Everolimus (RAD001)

Başlangıç

01.12.2006

Tahmini bitiş

01.03.2009

Ülkeler

United States

İlgili genler

Merkezler

• Las Vegas, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion criteria:

* Age ≥ 18 years old.
* Patients with metastatic colorectal cancer (CRC).
* Patients must have sufficient and obtainable tumor tissue for biomarker analysis from original surgical resection.
* Patients with documented disease progression within 6 months of their most recent dose of chemotherapeutic regimens.
* Patients with at least one measurable lesion.
* Adequate bone marrow function.
* Adequate liver function.
* Adequate renal function.
* Patients with a life expectancy of \> 3 months.
* Patients with a World Health Organization (WHO) performance status of 0, 1, or 2.
* Women of childbearing potential must have had a negative serum pregnancy test 72 hours prior to the administration of the first study treatment.
* Patients who give a written informed consent obtained according to local guidelines.

Exclusion criteria:

* Patients currently receiving anti-cancer agents or who have received these within 4 weeks prior to study entry.
* Patients who have previously received RAD001.
* Patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients.
* Chronic treatment with steroids or another immunosuppressive agent.
* Patients with untreated central nervous system (CNS) metastases or neurologically unstable CNS metastases.
* HIV seropositivity.
* Patients with an active, bleeding diathesis. Patients may use enoxaparin.
* Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
* Patients who have a history of another primary malignancy \< 3 years, with the exceptions of non-melanoma skin cancer, and carcinoma in situ of uterine cervix.
* Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
* Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to first study treatment.
* Patients unwilling to or unable to comply with the protocol.

Other protocol defined inclusion/exclusion criteria may apply