Advanced Cancer Clinical Trial
Official title:
A Phase I Trial of Lenvatinib (Multi-kinase Inhibitor) and Capecitabine (Anti-metabolite) in Patients With Advanced Malignancies
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:
- Participant will have a physical exam.
- Blood (about 3 teaspoons) will be drawn for routine tests.
- If participant is enrolled in Phase 2, they will have a tumor biopsy for biomarker
testing.
- If participant is enrolled in Phase 2, blood (about 2 teaspoons) will be drawn for
biomarker, CTC, and cfDNA testing.
During Week 3 of Cycle 1, blood (about 3 teaspoons) will be drawn for routine tests.
During Week 1 of Cycles 2 and beyond:
- Participant will have a physical exam.
- Blood (about 3 teaspoons) will be drawn for routine tests.
- If participant is enrolled in Phase 2, blood (about 2 teaspoons) will be drawn for
biomarker, CTC, and cfDNA testing.
- If participant can become pregnant, blood (about 1 teaspoon) will be collected for a
pregnancy test.
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:
- Participant will have a physical exam.
- Blood (about 3 teaspoons) will be drawn for routine tests.
- Participant will have a CT scan or MRI to check the status of the disease.
- If participant can become pregnant, blood (about 1 teaspoon) or urine will be collected
for a pregnancy test.
- If participant is enrolled in Phase 2, blood (about 2 teaspoons) will be drawn for
biomarker, CTC, and cfDNA testing.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03181854 -
Randomized Controlled Trial of Integrated Early Palliative Care
|
N/A | |
Completed |
NCT01197170 -
Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance
|
Phase 1 | |
Recruiting |
NCT05045040 -
Empathetic Communication Facilitation Program for Early Initiation of End-of-life Discussions
|
N/A | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03994601 -
An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
Completed |
NCT01393990 -
A Study of LY2228820 in Participants With Advanced Cancer
|
Phase 1 | |
Completed |
NCT02857270 -
A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT04121676 -
Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer
|
Phase 1 | |
Active, not recruiting |
NCT03177291 -
Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC
|
Phase 1 | |
Completed |
NCT03980041 -
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
|
Phase 2 | |
Active, not recruiting |
NCT03674567 -
Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab
|
Phase 1/Phase 2 | |
Recruiting |
NCT04823377 -
Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
|
N/A | |
Completed |
NCT02778126 -
A Study of Prexasertib (LY2606368) in Participants With Advanced Cancer
|
Phase 1 | |
Completed |
NCT02507544 -
A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer
|
Phase 1 | |
Completed |
NCT02529553 -
A Study of LY3076226 in Participants With Advanced or Metastatic Cancer
|
Phase 1 | |
Completed |
NCT02245204 -
Phase I Studies of Chlorogenic Acid for Injection for Tolerance and Pharmacokinetic of Advanced Cancers
|
Phase 1 | |
Completed |
NCT01583777 -
Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer
|
Phase 1 | |
Terminated |
NCT01929941 -
An Open-Label Study of a Novel JAK-inhibitor, INCB047986, Given in Patients With Advanced Malignancies
|
Phase 1 |