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Phase 1-2 study of everolimus and low-dose oral cyclophosphamide in patients with metastatic renal cell cancer.

Primary: Phase I part 1) Assessment of the recommended dosing and schedule for metronomic cyclophosphamide when administered in combination with fixed dose (10 mg) oral everolimus in patients with mRCC with respect to the selective induction of CD4+…

A comprehensive and targeted therapy approach in pediatric malignant pontine gliomas

Phase A:Primary objective: Determining the feasibility of gemcitabine as a radiosensitizer in DIPG Secondary objective: Evaluation of efficacy in terms of clinical and radiological response rate and progression free survivalTertiary objectives:…

An open-label, single arm, Phase Ib/II study of AEB071 (a protein kinase C inhibitor) and everolimus (mTOR inhibitor) in patients with CD79-mutant or ABC subtype diffuse large B-cell lymphoma

Phase Ib:Estimate the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of AEB071 and everolimus combination therapy inpatients with DLBCLPhase II:Assess the preliminary evidence for anti-tumor activity at R2PD for AEB071 and…

A two parts, biomarker study to identify genetic aberrations predictive for response on Everolimus in solid tumors without regular treatment options (CPCT*03)

Primary objective first part: analyse a set of 1951 genes for prediction of response measured by progression free survival ratio (TTP1:TTP2) on mTOR inhibition.Primary objective second part: to assess the ratio of progression free survival (TTP1:…

Pilot study on the determination of intratumoral concentrations of kinase inhibitors in patients with advanced solid malignancies

The main objective of this pilot study is to determine intratumoral concentrations of kinase inhibitors upon 2 weeks of treatment in tumor tissue of patients.

Pilot study of everolimus in the treatment of advanced malignancies in patients with Peutz-Jeghers syndrome

To determine the efficacy (as measured by objective tumor response) of single agent everolimus in the treatment of advanced malignancies or high risk polyps of patients known with PJS .

An open-label, multicenter phase II study to compare the efficacy and safety of RAD001 as first-line followed by second-line sunitinib versus sunitinib as first-line followed by second-line RAD001 in the treatment of patients with metastatic renal cell carcinoma

To evaluate the probability that the progression free survival (PFS) in the first-line treatment with RAD001 is non-inferior to the first-line treatment with sunitinib for patients with metastatic renal cell carcinoma (primary objective).…

A phase II study to investigate the efficacy of RAD001 (Afinitor ®, everolimus) in patients with irresectable recurrent or metastatic differentiated, undifferentiated (anaplastic) and medullary thyroid carcinoma

Primary objective: To determine the efficacy of RAD001 in patients with progressive irresectable recurrent or metastatic differentiated thyroid carcinoma Secondary objectives:-To determine maximum percentage of tumor reduction-To describe activity…

A phase Ib/II study investigating the combination of RAD001 with trastuzumab and paclitaxel in patients with HER2-overexpressing metastatic breast cancer.

To evaluate the efficacy of the dose level/regimen(s) of RAD001recommended from the phase I with HT therapy. This will bebased on the evaluation of overall response rate according toRECIST [Post-Text Supplement 1].

Phase I study of Everolimus combined with Metformin for patients with advanced cancer

To determine the dose limiting toxicity (DLT) and the maximum tolerated dose and recommended dose of the combination of everolimus orally once daily and metformin orally BID to patients with advanced solid tumors.

Clinical evaluation of the underlying mechanisms of targeted therapy related toxicities

The main objective of this pilot study is to determine the biological impact of treatment with targeted agents at the systemic and local tissue level in relation to toxicity.

An open-label, multi-center, expanded access study for postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer who have progressed following prior endocrine therapy, investigating the treatment of everolimus (RAD001) in combination with exemestane

Primary objective: to evaluate safety of everolimus in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer that is refractory to NSAIs.Secondary objective: to evaluate adverse events grade 3 and 4 in the…

Prediction of response to kinase inhibitors based on protein phosphorylation profiles in tumor tissue from advanced renal cell cancer patients

To determine the relation between tumor tissue phosphoproteomic profiles and progression-free survival (PFS) in patients with advanced RCC

An open-label, multi-center everolimus roll-over protocol for patients who have completed a previous Novartis-sponsored everolimus study and are judged by the investigator to benefit from continued everolimus treatment

Primary: To allow continued use of everolimus to patients receiving everolimus in a Novartis-sponsoredstudy which has reached its objectives and who are benefitting from treatment with everolimus as defined in the parent protocolSecondary: To…

prediction of everolimus-induced interstitial lung disease in breast cancer patients; maximizing efficacy by reducing toxicity

Primary objective:Analyze the value of pneumoproteins, everolimus exposure, pulmonary function tests, distinct radiological patterns, baseline patient characteristics and the development of skin toxicity or oral mucositis for the prediction of the…

A randomized, open-label phase II multicenter study evaluating the efficacy of oral Everolimus alone or in combination with Pasireotide LAR i.m. in advanced progressive pancreatic neuroendocrine tumors (PNET) * The COOPERATE-II study

PrimaryTo estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced PNET and to assess the predictive probability of success in a…

Targeted therapy selection based on tumor tissue kinase activity profiles for patients with advanced solid malignancies, an exploratory study

To select targeted treatment based on ex vivo kinase activity inhibition profiles to targeted agents of tumor tissue from patients with advanced cancer for whom no standard treatment is available.

An open-label, multi-center, expanded access study of RAD001 in patients with metastatic carcinoma of the kidney who are intolerant of or have progressed despite any available vascular endothelial growth factor receptor tyrosine kinase inhibitor therapy

The primary objective of the study is to evaluate additional safety of RAD001 in patients with MRCC who are intolerant of or whose disease has progressed despite any available prior VEGF receptor tyrosine kinaseinhibitor therapy.

Etude de phase 1 évaluant le RAD001 en association avec la radiothérapie dans les cancers bronchiques non à petites cellules

Primary objective: to evaluate the tolerability of the combination of RAD001 with radiotherapy.Secondary objective(s) To determine the antitumor activity of the combination of RAD001 (EVEROLIMUS) and radiotherapy (CR+PR+SD). To determine the…

89Zr-bevacizumab PET imaging as predictive biomarker for everolimus efficacy in patients with neuroendocrine tumors

To evaluate the feasibility of 89Zr-bevacizumab-PET imaging as predictive biomarker before and during treatment with everolimus in patients with neuroendocrine tumors.