Advertisement

Topics

Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol

2014-08-27 03:19:29 | BioPortfolio

Summary

This is a clinical trial investigating the effectiveness and safety of the study drug RAD001 in patients with advanced (metastatic) cholangiocarcinoma. Palliative chemotherapy provides some benefit to this group of patients. However, chemotherapy treatment only shows low rates of radiological response and short times to tumour progression. Therefore, further treatment options are urgently required.

In laboratory studies, RAD001 has been shown to interrupt the signals that cancer cells use to grow, spread and form new blood vessels (angiogenesis). RAD001 has been approved for the treatment of kidney cancer. It has also been approved for use in Australia for the treatment of patients with kidney and liver transplants, and has been used in thousands of patients worldwide for this indication. Preliminary studies suggest that RAD001 may have activity in a range of other cancers. This study will evaluate the activity of RAD001 in advanced cholangiocarcinoma.

Description

27 patients from approximately four hospitals in Australia will participate in this trial, with approximately 15 patients being enrolled at Austin Health. All participants will receive the same treatment (RAD001 10mg/d given orally).

After screening for eligibility, participants will receive RAD001 10mg/d until tumour progression.

Participants will undergo regular CT scans (every 6 weeks during treatment) to evaluate the effectiveness of treatment. Providing they are tolerating treatment satisfactorily, they may receive study treatment until progression of disease.

Blood samples will be taken during the screening phase and every 3 weeks during the treatment phase of the trial. Participants will be followed-up every 3 months to find out about survival status, new chemotherapy or biological treatment and the outcome of any ongoing adverse events.

Study Design

Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cholangiocarcinoma

Intervention

RAD001

Location

Austin Health
Melbourne
Victoria
Australia
3084

Status

Recruiting

Source

Austin Health

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:29-0400

Clinical Trials [230 Associated Clinical Trials listed on BioPortfolio]

RAD001 and Bicalutamide for Androgen Independent Prostate Cancer

The goal of this clinical trial is to learn if the study drug RAD001 in combination with Bicalutamide can slow the growth of prostate cancer. The safety of RAD001 given together with Bica...

RAD001 for Children With Chemotherapy-Refractory Progressive or Recurrent Low-Grade Gliomas

The purpose of this research study is to learn if the study drug RAD001 can shrink or slow the growth of low-grade gliomas. Additionally, the safety of RAD001 will be studied. RAD001 is a...

Study of RAD001 in Adenoid Cystic Carcinoma

- Although mTOR is clearly an attractive therapeutic target in tumor, no clinical study on mTOR inhibition by RAD001 has been systematically conducted in adenoid cystic carcinom...

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...

Study of RAD001 in Soft Tissue Extremity and/or Retroperitoneal Sarcomas

The goal of this clinical research study is to learn if the study drug RAD001 can stop or slow the growth of resectable soft tissue sarcoma. The patient's physical state, their symptoms, c...

PubMed Articles [121 Associated PubMed Articles listed on BioPortfolio]

Platelet-Derived Growth Factor-D Enables Liver Myofibroblasts to Promote Tumor Lymphangiogenesis in Cholangiocarcinoma.

/Aims. In cholangiocarcinoma, early metastatic spread via lymphatic vessels often precludes curative therapies. Cholangiocarcinoma invasiveness is fostered by an extensive stromal reaction, enriched i...

Cholangiocarcinoma: Treatment, Outcomes, and Nutrition Overview for Oncology Nurses.

Cholangiocarcinoma is a cancer that arises from the bile ducts inside or outside of the liver. Although it is a rare cancer, cholangiocarcinoma appears to be rising in incidence in the United States a...

Neurotensin promotes cholangiocarcinoma metastasis via the EGFR/AKT pathway.

Cholangiocarcinoma (CCA) is a fatal disease with increasing morbidity and poor prognosis due to poor response to conventional chemotherapy or radiotherapy. Neurotensin (NTS) has long been recognized a...

Clinical and pathological features of combined hepatocellular-cholangiocarcinoma compared with other liver cancers.

Combined hepatocellular-cholangiocarcinoma (CHC) is a primary liver cancer containing both hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC) elements. Its reported clinicopathol...

Endobiliary radiofrequency ablation for distal extrahepatic cholangiocarcinoma: A clinicopathological study.

Most patients with distal extrahepatic cholangiocarcinoma have developed jaundice or cholangitis at the time of initial diagnosis, which can delay surgery. We aim to evaluate the actual EB-RFA ablatio...

Medical and Biotech [MESH] Definitions

Cholangiocarcinoma arising near or at the confluence of the right and left hepatic ducts (COMMON HEPATIC DUCT). These tumors are generally small, sharply localized, and seldom metastasizing.

A malignant tumor arising from the intrahepatic bile duct epithelium. It is composed of ducts lined by cuboidal or columnar cells that do not contain bile, with abundant stroma. (From Holland et al., Cancer Medicine, 3d ed, p1455; Stedman, 25th ed)

More From BioPortfolio on "Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Palliative Care
Palliative care is the active holistic care of patients with advanced progressive illness. Management of pain and other symptoms and provision of psychological, social and spiritual support is paramount. The goal of palliative care is achievement of the ...


Searches Linking to this Trial