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Carcinoma, Renal Cell clinical trials

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NCT ID: NCT02019693 Completed - Kidney Cancer Clinical Trials

A Phase 2 Study of the MET Kinase Inhibitor INC280 in Papillary Renal Cell Cancer

Start date: January 24, 2014
Phase: Phase 2
Study type: Interventional

Background: - Papillary Renal Cell Cancer (RCC) is the second most common histologic subtype of kidney cancer, accounting for approximately 10-15% of cases - Type 1 papillary RCC occurs in both sporadic and hereditary forms, which are histologically identical. Non familial type 1 papillary RCC can present as both solitary renal tumors and as bilateral, multifocal disease - There are no standard agents of proven efficacy for patients with advanced papillary RCC. - Patients with disease localized to the kidney are managed surgically while patients with advanced/unresectable disease are usually managed in the community with vascular endothelial growth factor (VEGF) pathway antagonists or mechanistic target of rapamycin (mTOR) inhibitors. - Activating mutations of mesenchymal epithelial transition (MET) were identified in the germline of affected hereditary papillary renal cancer (HPRC) patients, who have a predilection for the development of bilateral, multifocal type 1 papillary RCC. Somatic MET mutations have been found in a subset of patients with non-inherited, sporadic papillary renal carcinoma - The investigational agent Capmatinib (INC280) is a selective MET inhibitor lacking activity against the VEGF pathway - This is a proof-of-concept study using INC280 in patients with papillary RCC to test the idea that effectively blocking the hepatocyte growth factor (HGF)/MET pathway will lead to clinical activity in patients with papillary renal cell cancer Objectives: Primary Objective: -To determine the overall response rate (Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in patients with papillary renal cell carcinoma treated with single agent INC280 Eligibility: - Diagnosis of hereditary papillary renal carcinoma (HPRC) or sporadic papillary renal cell carcinoma (RCC) - Patients with bilateral multifocal disease can have tumors localized to the kidney or have metastatic disease - Patients with sporadic papillary RCC (but without multifocal disease) should have advanced disease that is considered unresectable - Eastern Cooperative Oncology Group (ECOG) 0-2 - Measurable disease - Adequate organ function - No active brain metastases - Prior therapy - No more than 3 prior lines of systemic therapy - Prior therapy with a MET inhibitor is allowed as long as the patient has not had progressive disease while receiving the agent Design: - This is a phase 2 single center non-randomized trial. - The study will be conducted using a Simon 2 stage minimax design. Initially 13 evaluable subjects will be recruited. If there are no responses to therapy, the study will be terminated. If there is at least 1 response an additional 7 evaluable subjects will be accrued. - The two-stage minimax design is based on assuming an ineffective response rate of 5% and a targeted effective response rate of 25%. We also assume that the probability of accepting an ineffective treatment and the probability of rejecting an effective treatment are each 10%. - Subjects will be dosed orally at a starting dose of 600 mg twice daily. - The overall response rate (complete response + partial response) will be determined.

NCT ID: NCT02019576 Completed - Clinical trials for Clear Cell Metastatic Renal Cell Carcinoma

Stereotactic Radiotherapy for Metastatic Kidney Cancer Being Treated With Sunitinib

Start date: May 2014
Phase: Phase 2
Study type: Interventional

Stereotactic radiotherapy (SRT) is a newer type of focused radiation therapy that precisely and accurately delivers high dose radiation to a tumour, while sparing much of the nearby normal organs. The use of stereotactic radiotherapy results in high rates of tumour destruction with minimal side effects which are very well tolerated. Often stereotactic radiotherapy has been used to try to cure patients who have an early stage cancer which has not spread, but there is less experience with using it in patients with cancer which has spread. The purpose of this study is to measure how well stereotactic radiotherapy can destroy kidney cancer tumours which are no longer being controlled by Sunitinib and to measure how much longer such an approach will allow patients to stay on Sunitinib before needing to switch to another medication. Stereotactic radiotherapy will be used to treat only the growing tumours and then patients will continue with Sunitinib.

NCT ID: NCT02016391 Completed - Cancer of Liver Clinical Trials

Effects of Dexmedetomidine During Radiofrequency Ablation of Abdominal Tumours

Start date: December 2013
Phase: Phase 4
Study type: Interventional

The purpose of he study is to evaluate effects of dexmedetomidine on pain during radiofrequency ablation of liver and kidney tumours.

NCT ID: NCT02014636 Completed - Clinical trials for Carcinoma, Renal Cell

Safety and Efficacy Study of Pazopanib and MK 3475 in Advanced Renal Cell Carcinoma (RCC; KEYNOTE-018)

Start date: December 27, 2013
Phase: Phase 1
Study type: Interventional

This is an open-label, 2 part study of pazopanib and/or MK 3475 in treatment naïve subjects with advanced RCC. Part 1 consists of a Phase I dose escalation of pazopanib + MK 3475 followed by an expansion cohort to determine the maximum tolerated regimen and the recommended Phase II dose. Part 2 is a randomized 3-arm Phase II study to evaluate the clinical efficacy and safety of pazopanib + MK 3475 as compared to single-agent pazopanib and single-agent MK 3475. The objectives of this Phase I/II study are to test the safety and tolerability of pazopanib in combination with MK 3475, and study the clinical efficacy of pazopanib in combination with MK 3475 in subjects with advanced RCC as compared with single-agent pazopanib and single-agent MK 3475. Following the Urgent Safety Measure (USM) released on February 09, 2017, the phase II (Part 2) portion of this study will not commence.

NCT ID: NCT02009449 Active, not recruiting - Breast Cancer Clinical Trials

A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors

IVY
Start date: November 15, 2013
Phase: Phase 1
Study type: Interventional

This is a first-in-human, open-label, dose escalation study to evaluate the safety and tolerability of pegilodecakin in participants with advanced solid tumors, dosed daily subcutaneously as a monotherapy or in combination with chemotherapy or immunotherapy.

NCT ID: NCT02005614 Terminated - Breast Cancer Clinical Trials

A Pilot/Phase II Study of Gamma Knife Radiosurgery for Brain Metastases Using 3Tesla MRI and Rational Dose Selection

Start date: November 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to collect prospective data for use as a comparator for future subsequent studies attempting to increase the efficacy or reduce the toxicity of gamma knife radiosurgery.

NCT ID: NCT02002312 Completed - Clinical trials for Metastatic Clear Cell Renal Cell Carcinoma

Phase II Study of Lutetium-177 Labeled Girentuximab in Patients With Advanced Renal Cancer

Start date: August 2011
Phase: Phase 2
Study type: Interventional

To determine the efficacy of multiple doses Lutetium-177-DOTA-girentuximab in patients with advanced clear cell renal cell carcinoma using RECIST criteria.

NCT ID: NCT02001493 Recruiting - Clinical trials for Renal Cell Carcinoma

Metabolomic Profiling in Renal Cell Carcinoma

Start date: January 2014
Phase: N/A
Study type: Observational

Antiangiogenics are the mainstay of treatment in patients with metastatic renal cell carcinoma. Conventional clinical end-points, used to measure efficacy with chemotherapeutic agents, have not been helpful in monitoring the efficacy of antiangiogenic therapy. Increasing numbers of predictive and pharmacodynamic biomarkers are being investigated that are useful surrogates for clinical response and also to identify patients early on who will benefit from this class of agents. This is valuable in avoiding unnecessary toxicity in patients and also in reducing cost implications of this expensive group of drugs. The investigators wish to explore the variability of baseline metabolomic profile in the blood and urine of patients with mRCC and characterise the inter-subject and intra-subject variability. The study of the baseline levels has not been performed in this cohort previously. This is extremely important in interpreting the emerging data of changes in the levels of the various biomarkers from various trials. This will in turn help in the development of future targeted therapies, especially Phase I/II studies where an early demonstration of target modulation is vital. This study will also help to identify the number of patients required for appropriate statistical evaluation in pharmacodynamic studies to assess biological activity, optimisation of dosing, and investigation of potential mechanisms of resistance. Study of the urinary and blood metabolomic profile in conjunction will give us an insight into the potential use of urine as a diagnostic and prognostic tool. OBJECTIVES GOAL The main objective of the study is to determine the change from baseline in metabolomic profiling in patients with clear cell renal cell carcinoma 1 month after nephrectomy or antiangiogenic treatment during 2 months

NCT ID: NCT01997788 Completed - Clinical trials for Renal Cell Carcinoma

The Intrathecal Morphine for Nephrectomy

EMPON
Start date: August 2013
Phase: N/A
Study type: Interventional

To evaluate the efficacy and the safety of the intrathecal morphine injection in the open nephrectomy.

NCT ID: NCT01984242 Completed - Clinical trials for Renal Cell Carcinoma

A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) as Monotherapy or in Combination With Bevacizumab (Avastin®) Compared to Sunitinib (Sutent®) in Participants With Untreated Advanced Renal Cell Carcinoma

IMmotion150
Start date: January 8, 2014
Phase: Phase 2
Study type: Interventional

This multicenter, randomized, open-label study will evaluate the efficacy, safety and tolerability of atezolizumab as monotherapy or in combination with bevacizumab versus sunitinib in participants with histologically confirmed, inoperable, locally advanced or metastatic renal cell carcinoma who have not received prior systemic therapy either in the adjuvant or metastatic setting.