Renal Cell Carcinoma Clinical Trial
Official title:
A Phase I Study of RAD001 and Sunitinib in Metastatic Renal Cell Carcinoma Patients
The purpose of this study is to test the safety of RAD-001 and Sunitinib given in
combination for renal cell cancer. We also want to find out what effects (good and bad) the
combination of RAD-001 and Sunitinib have on you and your tumor.
RAD001 is a pill that works by shutting down some of the pathways in the cell that make
tumors grow. Sunitinib is a pill that works by shutting off the signal in the cancer cells
that tell the cells to grow blood vessels. Without this signal, the blood vessels to the
tumors shrink down.
To assess the maximum tolerated doses and overall safety and tolerability of Sunitinib
administered in combination with RAD001 for the treatment of patients with metastatic renal
cell carcinoma.
To assess antitumor activity of the combination of Sunitinib and RAD001.
This study is designed to confirm that the 2 agents can be administered safely in
combination. Patients will begin treatment with Sunitinib and RAD001 on Day 1. RAD001 will
be administered orally on a weekly schedule. Sunitinib will be given orally on a 4 weeks on,
2 weeks off schedule. DLT determination will be based on toxicities observed in Cycle 1 - a
cycle is defined by Sunitinib dosing ( 6 weeks). Once the MTD for the combination has been
identified, a total of 10 patients will be enrolled at the highest dose level that allows
for administration of multiple cycles and provides potentially therapeutic drug levels of
both drugs to further assess safety and tolerability and to obtain a preliminary assessment
of efficacy. Patients will be treated with RAD001 and Sunitinib until there is disease
progression, significant toxicity or withdrawal of patient consent. Patients judged to
derive benefit from treatment would be offered participation in a continuation protocol at
the conclusion of this study.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04987203 -
Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma
|
Phase 3 | |
| Recruiting |
NCT06391879 -
Establishment of a Multidimensional Prediction Model for the Natural Course of VHL Disease-related Renal Cell Carcinoma
|
||
| Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
| Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
| Terminated |
NCT03655613 -
APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT05418387 -
A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona
|
N/A | |
| Recruiting |
NCT04623502 -
An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy
|
N/A | |
| Completed |
NCT02853344 -
Study of Pembrolizumab (MK-3475) Monotherapy in Locally Advanced/Metastatic Renal Cell Carcinoma (MK-3475-427/KEYNOTE-427)
|
Phase 2 | |
| Terminated |
NCT04088500 -
A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma
|
Phase 2 | |
| Completed |
NCT05070637 -
Circulating Tumor Cell Reducing No-touch Nephrectomy
|
N/A | |
| Active, not recruiting |
NCT03634540 -
A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)
|
Phase 2 | |
| Not yet recruiting |
NCT06049030 -
A Study of HS-10516 in Patients With Advanced Clear Cell Renal Cell Carcinoma
|
Phase 1 | |
| Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
| Completed |
NCT01358721 -
Phase I Biomarker Study (BMS-936558)
|
Phase 1 | |
| Active, not recruiting |
NCT04503148 -
Anesthesia and Cancer Study: Renal Cell Carcinoma
|
N/A | |
| Completed |
NCT02386826 -
INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme
|
Phase 1 | |
| Not yet recruiting |
NCT05808608 -
A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT03323710 -
Study of Propranolol Plus Sunitinib in First-line Treatment of Metastatic Renal Cell Carcinoma
|
Phase 2 | |
| Completed |
NCT03052504 -
Prospective Versus Retrospective Complications in Radical Cystectomy and Nephrectomy
|