Study of Dalantercept and Axitinib in Patients With Advanced Renal Cell Carcinoma

Summary

The purpose of Part 1 of this study is to evaluate the safety and tolerability of dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (RCC) to determine the recommended dose level of dalantercept in combination with axitinib for Part 2. The purpose of Part 2 of this study is to determine whether treatment with dalantercept in combination with axitinib prolongs progression free survival (PFS) compared to axitinib alone in patients with advanced renal cell carcinoma (RCC).

Timeline

Start

2012-12

Primary completion

2017-06

Completion

2017-11

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

Stopped: “The study was terminated by the sponsor following unblinding of the Progression Free Survival endpoint.”

paper hazard ratio, 1.11 [95% CI, 0.71-1.73; P = .670]). PMID 30951193 ↗

Publications

• Voss MH, Bhatt RS, Vogelzang NJ, Fishman M, Alter RS, Rini BI, Beck JT, Joshi M, Hauke R, Atkins MB, Burgess E, Logan TF, Shaffer D, Parikh R, Moazzam N, Zhang X, Glasser C, Sherman ML, Plimack ER. A phase 2, randomized trial evaluating the combination of dalantercept plus axitinib in patients with advanced clear cell renal cell carcinoma. Cancer. 2019 Jul 15;125(14):2400-2408. doi: 10.1002/cncr.32061. Epub 2019 Apr 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dalantercept	Protein / enzyme biologic	0.6 mg/kg	Subcutaneous
Subject	Dalantercept	Protein / enzyme biologic	0.9 mg/kg	Subcutaneous
Subject	Dalantercept	Protein / enzyme biologic	1.2 mg/kg	Subcutaneous
Subject	Dalantercept	Protein / enzyme biologic	1.5 mg/kg	Subcutaneous
Background	Axitinib	Small molecule	5 mg	Oral

Indications