Full TitlePhase 1/2 Study of Navitoclax Plus Vistusertib in Patients with Relapsed Small Cell Lung Cancer (SCLC) and Other Solid Tumors (NCI# 10070)(CIRB)
The purpose of this study is to assess the safety and effectiveness of combining the investigational drugs navitoclax and vistusertib in patients with small cell lung cancer and other solid tumors that have continued to grow despite standard treatments or cannot be cured with available therapies. Navitoclax is thought to work by inhibiting proteins that keep cancer cells alive. Vistusertib blocks a protein called mTOR which is involved in cancer cell growth.
Laboratory studies have shown that combining these drugs is more effective against small cell lung cancer than either treatment alone. Both medications are taken orally (by mouth).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients participating in the Phase I (dose-finding) portion of the study must have an advanced solid tumor that cannot be successfully treated with standard therapies.
- Patients in the Phase II part of the study (evaluating the safety and effectiveness of the two-drug combination) must have small cell lung cancer that came back or continued to grow after previous treatment that included a platinum-containing drug.
- At least 3 weeks must pass between the completion of previous treatment and entry into the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for patients age 18 and older.