This study is currently not recruiting participants.

A041-04; A Phase 2 Randomized Double-Blind Study of Dalantercept and Axitinib Compared to Placebo and Axitinib in Patients With Advanced Renal Cell Carcinoma

Investigating the Safety and Efficacy of an Investigational Medication with a Type of Cancer Medication for Advanced Renal Cell Carcinoma

Not Recruiting
18 years - 100 years
All
Phase N/A

Brief description of study.

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).

Detailed description of study

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).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Renal cell carcinoma
  • Age: 18 years - 100 years
  • Gender: All

This study investigates the safety and effectiveness of an investigational medication combined with axitinib for patients with advanced renal cell carcinoma, a type of kidney cancer. The goal is to find the best dose for this combination and to see if it can help patients live longer without their cancer getting worse.

Participants will be divided into study arms: one group will receive the investigational medication along with axitinib, and another group will receive axitinib alone. The study will monitor how well patients tolerate the treatment and how it affects their cancer.

  • Who can participate: Adults with advanced renal cell carcinoma may be eligible to participate. Specific medical criteria must be met, which will be evaluated by the study team.
  • Study details: Participants will receive either the investigational medication with a type of cancer medication or the cancer medication alone. A placebo is not used in this study.
Updated on 19 Feb 2024. Study ID: 1405027173

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