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| Name | Class |
|---|---|
| Eisai Inc. | INDUSTRY |
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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.
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).
Study Visits:
During Week 2 of Cycle 1:
During Week 3 of Cycle 1, blood (about 3 teaspoons) will be drawn for routine tests.
During Week 1 of Cycles 2 and beyond:
During Weeks 2 and 3 of Cycles 2 and beyond, participant will be called by a member of the study staff and asked about any side effects they may have. This call should last about 5-10 minutes.
During Week 3 of Cycle 2 and then every even-numbered cycle after that (Cycles 4, 6, 8, and so on), participant will have a CT scan or MRI.
End-of-Study Visit:
After participant's last dose of study drug, they will have an end-of-study visit. At this visit, the following tests and procedures will be performed:
This is an investigational study. Lenvatinib is FDA approved and commercially available for the treatment of certain types of thyroid cancer. Capecitabine is FDA approved and commercially available for the treatment of certain types of breast and colorectal cancers. It is considered investigational to use lenvatinib and capecitabine to treat advanced cancer.
The study doctor can explain how the study drugs are designed to work.
Up to 46 participants will be enrolled in this study. All will take part at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenvatinib + Capecitabine | Experimental | Phase 1 Study Escalation: Group consists of participants with various solid tumors. Dose of Lenvatinib received depends on when joining study. First group of participants receive lowest dose level of Lenvatinib. Each new group receives a higher dose of Lenvatinib than the group before it, if no intolerable side effects were seen. This continues until highest tolerable dose of Lenvatinib found. All participants receive the same dose of Capecitabine. Phase 2 Study Expansion: Group consists of participants with advanced breast cancer and any solid tumors with confirmed FGFR abnormalities. Participants receive Lenvatinib at the highest dose that was tolerated in Dose Escalation Phase. All participants receive the same dose of Capecitabine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenvatinib | Drug | Phase 1 Dose Escalation: Starting dose of Lenvatinib 10 mg by mouth once daily of a 21 day cycle. Phase 2 Dose Expansion: Starting dose of Lenvatinib is maximum tolerated dose from Phase 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Combination Treatment with Lenvatinib and Capecitabine in Advanced and/or Metastatic Cancer Refractory to Standard Treatment | 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, | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Antitumor Efficacy of Combination of Lenvatinib and Capecitabine in Breast Cancer and Solid Tumors with FGFR Abnormality | Efficacy evaluation done using RECIST criteria version 1.1. | 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David S. Hong, MD | M.D. Anderson Cancer Center | Principal Investigator |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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|
| Capecitabine | Drug | Phase 1 Dose Escalation and Phase 2 Dose Expansion: Capecitabine 1000 mg/m2 twice daily by mouth on Days 1 - 14 of a 21 day cycle. |
|
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D014571 | Urologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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