NCT03097328

Study of TAK-228 In Patients With Previously Treated Metastatic Renal Cell Carcinoma

A Phase II Study of TAK-228 In Patients With Previously Treated Metastatic Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Bradley A. McGregor, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is investigating a drug as a possible treatment for metastatic renal cell carcinoma. The intervention involved in this study is TAK-228.

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has not approved TAK-228 as a treatment for any disease but it is being investigated as a treatment for advanced solid tumors, blood disorders, and inflammatory diseases. TAK-228 works to inhibit or interfere with cellular functions involved in cell growth and survival. TAK-228 specifically targets a type of protein that can make chemicals that trigger cell growth, including cancer cell growth. This protein may also cause cells to produce proteins that trigger the development of new blood vessels. Cancers need new blood vessels in order to grow. In some types of cancer, this type of protein (mTOR) is switched on, and it makes the cancer cells grow and produce new blood vessels. mTOR blockers (inhibitors) are a newer type of cancer growth blocker that can stop the growth of some types of cancer. Researchers hope to learn how participants with previously treated mRCC will respond to treatment with TAK-228. Other goals of this study include assessing the types of side effects associated TAK-228 and whether there is a relationship between certain genetic mutations (changes to your DNA) and participant responses to the drug.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	TAK-228	TAK-228 works to inhibit or interfere with cellular functions involved in cell growth and survival. TAK-228 specifically targets a type of protein that can make chemicals that trigger cell growth, including cancer cell growth

Timeline

• Start date: 2017-08-01
• Primary completion: 2021-07-20
• Completion: 2024-04-24
• First posted: 2017-03-31
• Last updated: 2024-04-29
• Results posted: 2022-02-24

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study