Carcinoma, Renal Cell Clinical Trial
Official title:
A Dose-Ranging, Phase II, Open Label Study of ATN 161 in Advanced Renal Cell Cancer
The purpose of this study is to determine an active dose of ATN-161 for future studies while establishing preliminary evidence of effectiveness in patients with renal cell cancer.
Angiogenesis, defined as the growth of new blood vessels from pre-existing vessels, is a
requirement for the growth of nearly all tumors. Clear cell renal cell carcinoma (CCRCC) is
a malignancy characterized by abundant vascularization and a high degree of resistance to
chemotherapy which makes antiangiogenic therapy an intriguing concept for treatment. This
concept has been established by the initial successes observed in recent studies of
antiangiogenic therapies for CCRCC. ATN-161 is an attractive candidate for investigation as
a therapeutic agent in CCRCC because it binds to several fully activated integrins, which
are essential downstream components in the angiogenic signaling cascade.
Functional imaging using dceMRI has been demonstrated as an effective way to show effects on
the vasculature across different tumors, including CCRCC. Preclinical experiments have shown
that ATN-161 affects tumor perfusion in tumor bearing mice. Therefore, use of imaging in
this study is expected to be an effective method for evaluating the antiangiogenic response
to ATN-161.
Patients will be administered ATN-161 three times weekly by short (10 minute) IV infusion at
1 of 3 dose levels (20, 100, and 600 mg). Patients will be treated until progression of
disease, unacceptable drug toxicity, or withdrawal of consent occurs.
Functional imaging (dceMRI) will be performed within 1 week prior to first treatment, again
during the second week of treatment, and finally during the fourth week of treatment.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02248389 -
Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Renal Masses
|
Phase 1 | |
| Completed |
NCT03900364 -
a Prospective Trial Comparing Robot-assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy
|
N/A | |
| Completed |
NCT00158782 -
Study Of Safety And Tolerability Of GW786034 Given With Lapatinib In Cancer Patients
|
Phase 1 | |
| Completed |
NCT03109015 -
Alternative Schedule Sunitinib in Metastatic Renal Cell Carcinoma: Cardiopulmonary Exercise Testing
|
Phase 2 | |
| Completed |
NCT00363194 -
A Two-way Crossover Study Of The Effect Of Food On The Pharmacokinetics Of Pazopanib In Cancer Patients
|
Phase 1 | |
| Completed |
NCT01012011 -
Regulatory Post Marketing Surveillance Study on Nexavar®
|
N/A | |
| Completed |
NCT00842790 -
Impact of Predicting Anti-angiogenic Response in mRCC Using Functional Imaging
|
N/A | |
| Completed |
NCT00529802 -
Exploratory Study Evaluating Fluorodeoxyglucose - Position Emission Tomography as a Predictive Marker for Therapy With RAD001 in Metastatic Renal Cell Cancer
|
Phase 2 | |
| Completed |
NCT00338884 -
Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer
|
Phase 2 | |
| Completed |
NCT00387764 -
Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer
|
Phase 3 | |
| Completed |
NCT00356460 -
Safety and Efficacy Study of GC1008 to Treat Renal Cell Carcinoma or Malignant Melanoma
|
Phase 1 | |
| Completed |
NCT00095186 -
Safety/Efficacy Study of Oral Recombinant Human Lactoferrin in Renal Cell Carcinoma
|
Phase 2 | |
| Completed |
NCT00043368 -
PF-3512676 (CPG 7909) Injection For Patients Who Completed An Oncology Study Using PF-3512676 (CPG 7909)
|
Phase 2 | |
| Completed |
NCT00079612 -
Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT04489771 -
A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013)
|
Phase 2 | |
| Completed |
NCT00516672 -
Phase I Study of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors
|
Phase 1 | |
| Withdrawn |
NCT05104905 -
A Phase I/II Open Label Single Centre Trial to Assess the Safety, Tolerability and Efficacy of Single Dose Neoadjuvant Anti-CLEVER-1 Antibody Bexmarilimab in Localised Renal Cell and Colon Carcinoma
|
Phase 1/Phase 2 | |
| Terminated |
NCT03685591 -
PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors
|
Phase 1 | |
| Withdrawn |
NCT03111901 -
Low-dose Interleukin-2 and Pembrolizumab in Melanoma and Renal Cell Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05544929 -
A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers
|
Phase 1 |