Interleukin-2 With Sorafenib (BAY 43-9006) for Unresectable or Metastatic Clear Cell Renal Carcinoma (RCC) and Metastatic Melanoma

Phase 1 Completed 17 enrolled Ohio State University Comprehensive Cancer Center Bayer · collab Novartis · collab

NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this study will be to determine the toxicity and Maximum Tolerated Dose (MTD) of the combination of high dose aldesleukin and sorafenib in previously untreated patients with metastatic or unresectable clear cell renal carcinoma (RCC) and metastatic melanoma.

Timeline

Start: 2006-11-08
Primary completion: 2013-02-28
Completion: 2013-10

Publications

Results Monk P, Lam E, Mortazavi A, Kendra K, Lesinski GB, Mace TA, Geyer S, Carson WE 3rd, Tahiri S, Bhinder A, Clinton SK, Olencki T. A phase I study of high-dose interleukin-2 with sorafenib in patients with metastatic renal cell carcinoma and melanoma. J Immunother. 2014 Apr;37(3):180-6. doi: 10.1097/CJI.0000000000000023.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sorafenib	Small molecule	200 mg	Oral
Subject	Sorafenib	Small molecule	400 mg	Oral
Subject	aldesleukin	Protein / enzyme biologic	600000 iu/kg	Intravenous

Interleukin-2 With Sorafenib (BAY 43-9006) for Unresectable or Metastatic Clear Cell Renal Carcinoma (RCC) and Metastatic Melanoma

Summary

Timeline

Publications

Drugs

Indications