Advertisement

Topics

Phase II Study of Afinitor vs. Sutent in Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma

2014-08-27 03:14:26 | BioPortfolio

Summary

To compare the anti-tumor activity of everolimus and sunitinib in subjects with mRCC with non-clear cell pathology.

Description

This will be an international (USA, Canada, and UK) open-label, outpatient, multicenter, randomized study of treatment with RAD001 (everolimus (Afinitor®) or sunitinib (Sutent®) in subjects with mRCC and non-clear cell histology. Special emphasis is placed on papillary and chromophobe histologies while sarcomatoid clear cell variants, medullary, and collecting duct carcinomas will be excluded (see eligibility). Subjects may continue receiving study drugs until disease progression, unacceptable toxicities, or withdrawal of consent, for a maximum of 24 months. Continuation of study assigned treatment will be allowed beyond 24 months at the discretion of the sponsor. Stratification variables will include histology (papillary vs. chromophobe) and Motzer risk criteria (0, 1-2, and 3). Tumor progression will be assessed locally and by independent review, in strict accordance with Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria measured every 12 weeks. At the time of progression, subjects will be taken off study other than simple administrative mortality follow-up. Primary pathologic samples and plasma/urine angiokine levels at baseline and over time will be collected and stored centrally for biomarker analysis.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Advanced Non-clear Cell Renal Cell Carcinoma

Intervention

Everolimus, Sunitinib

Location

Duke Univeristy Medical Center
Durham
North Carolina
United States
27708

Status

Not yet recruiting

Source

Duke University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:26-0400

Clinical Trials [9044 Associated Clinical Trials listed on BioPortfolio]

Study in Non-Clear Cell Renal Carcinoma (Ncc-RCC) Temsirolimus Versus Sunitinib

This will be a prospective, open-label, randomized multicenter phase-II study to evaluate progression free survival (PFS) in patients with locally advanced or metastatic non-clear cell ren...

Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)

The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell ren...

Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma

This is a multicenter, randomized, open-label, Phase 3 study to compare the efficacy and safety of lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) versus sunitin...

Randomized Phase-II Study of Nivolumab Plus Ipilimumab Versus Sunitinib in Untreated and Advanced Non-clear Cell RCC

SUNNIFORECAST (Sunitinib vs. Nivolumab + Ipilimumab as First line treatment Of REnal cell CAncer of non-clear cell SubTypes) is a Phase II, randomized, open-label investigator initiated tr...

A Study of Varlilumab (Anti-CD27) and Sunitinib in Patients With Metastatic Clear Cell Renal Cell Carcinoma

This is a study to determine the clinical benefit (how well the drug works), safety, and tolerability of combining varlilumab and sunitinib. The study will enroll patients with metastatic...

PubMed Articles [33077 Associated PubMed Articles listed on BioPortfolio]

Mir-144-3p Promotes Cell Proliferation, Metastasis, Sunitinib Resistance in Clear Cell Renal Cell Carcinoma by Downregulating ARID1A.

We previously performed microRNA (miRNA) microarray to identify effective indicators of clear cell renal cell carcinoma (ccRCC) tissue samples and preoperative/postoperative plasma in which we identif...

MicroRNA-645 promotes cell metastasis and proliferation of renal clear cell carcinoma by targeting GK5.

To dissect the functioning mode of miR-645 on renal clear cell carcinoma cell metastasis and growth, and provide therapeutic targets for renal clear cell carcinoma.

Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma.

Background Nivolumab plus ipilimumab produced objective responses in patients with advanced renal-cell carcinoma in a pilot study. This phase 3 trial compared nivolumab plus ipilimumab with sunitinib ...

Updated European Association of Urology Guidelines Recommendations for the Treatment of First-line Metastatic Clear Cell Renal Cancer.

The randomised phase III clinical trial Checkmate-214 showed a survival superiority for the combination of ipilimumab and nivolumab when compared with the previous standard of care in first-line metas...

Presence of Intratumoral Calcifications and Vasculature Is Associated With Poor Overall Survival in Clear Cell Renal Cell Carcinoma.

The objective of this study was to explore the prognostic significance of the preoperative computed tomography (CT) features in clear cell renal cell carcinoma.

Medical and Biotech [MESH] Definitions

A heterogeneous group of sporadic or hereditary carcinoma derived from cells of the KIDNEYS. There are several subtypes including the clear cells, the papillary, the chromophobe, the collecting duct, the spindle cells (sarcomatoid), or mixed cell-type carcinoma.

A rare tumor of the female genital tract, most often the ovary, formerly considered to be derived from mesonephric rests. Two varieties are recognized: (1) clear cell carcinoma, so called because of its histologic resemblance to renal cell carcinoma, and now considered to be of muellerian duct derivation and (2) an embryonal tumor (called also ENDODERMAL SINUS TUMOR and yolk sac tumor), occurring chiefly in children. The latter variety may also arise in the testis. (Dorland, 27th ed)

An autosomal dominant disorder caused by mutations in a tumor suppressor gene. This syndrome is characterized by abnormal growth of small blood vessels leading to a host of neoplasms. They include HEMANGIOBLASTOMA in the RETINA; CEREBELLUM; and SPINAL CORD; PHEOCHROMOCYTOMA; pancreatic tumors; and renal cell carcinoma (see CARCINOMA, RENAL CELL). Common clinical signs include HYPERTENSION and neurological dysfunctions.

A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.

A carbonic anhydrase and transmembrane protein that consists of an N-terminal PROTEOGLYCAN-like domain, a catalytic region, a single-pass transmembrane domain, and a short intracellular tail. It functions as a dimer and is expressed primarily by cells of the GASTROINTESTINAL TRACT; BILE DUCT EPITHELIUM; and GALL BLADDER. It is expressed at high levels in many solid tumors, especially CLEAR CELL RENAL CARCINOMA, in response to CELL HYPOXIA.

More From BioPortfolio on "Phase II Study of Afinitor vs. Sutent in Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Renal Cell Carcinoma
Renal cell cancer (renal adenocarcinoma or hypernephroma) is the most common type of kidney cancer in adults. More than 8 in every 10 (80%) kidney cancers diagnosed in the UK are this type.  In renal cell cancer the cancerous cells start in the lini...

Blood
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...


Searches Linking to this Trial