Clinical Trial: Lenvatinib and Capecitabine in Patients With Advanced Malignancies

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase I Trial of Lenvatinib (Multi-kinase Inhibitor) and Capecitabine (Anti-metabolite) in Patients With Advanced Malignancies

Brief Summary:

There are 2 phases in this study: Phase 1 (dose escalation) and Phase 2 (dose expansion).

The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of lenvatinib and Xeloda (capecitabine) that can be given to patients with advanced cancer. The goal of Phase 2 of this study is to learn if the dose of lenvatinib and capecitabine found in Phase 1 can help to control advanced cancer.

The safety of this drug combination will be studied in both phases of the study.

Detailed Summary:

Study Groups:

If participant is are found to be eligible to take part in this study, they will be assigned to a study group based on when they join this study. Up to 4 groups of up to 18 participants will be enrolled in Phase 1 of the study, and up to 28 participants will be enrolled in Phase 2.

If participant is enrolled in Phase 1, the dose of lenvatinib they receive will depend on when they join this study. The first group of participants will receive the lowest dose level of lenvatinib. Each new group will receive a higher dose of lenvatinib than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of lenvatinib is found.

If participant is enrolled in Phase 2, they will receive lenvatinib at the highest dose that was tolerated in Phase 1.

All participants will receive the same dose of capecitabine.

Study Drug Administration:

Each study cycle is 21 days.

Participant will take lenvatinib by mouth every day and capecitabine by mouth 2 times every day.

Length of Study Participation:

Participant may continue taking the study drugs for as long as the doctor thinks it is in their best interest. Participant will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if they are unable to follow study directions.

Patient's participation on the study will be over after the end-of-study visit (described below).

MTD defined by dose limiting toxicities (DLTs) that occur in the first cycle. DLT defined as any clinically grade 3 or 4 non-hematologic toxicity as defined in the NCI CTC v4.0,