Lenvatinib and Capecitabine in Patients With Advanced Malignancies (NCT02915172) | Clinical Trial Compass
WithdrawnPhase 1
Lenvatinib and Capecitabine in Patients With Advanced Malignancies
0Started 2016-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with a histologically and/or cytologically confirmed solid tumor who are resistant / refractory to approved therapies or for whom no curative therapies are available.
. All previous treatment (including surgery, radiotherapy and systemic anti-neoplastic therapy) must have been completed at least three weeks prior to study entry and any acute toxicities must have resolved.
. Aged \>/= 18 years.
. Eastern Cooperative Oncology Group (ECOG) performance status score of \</= 2.
. Written informed consent prior to any study specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.
. Willing and able to comply with the protocol guidelines for the duration of the study.
Exclusion criteria
. Unstable metastases to the central nervous system (CNS).
. Any of the following laboratory parameters: a) hemoglobin \< 9 g/dL (5.6 mmol/L); b) neutrophils \<1.5 x 109/L; c) platelets \<100 x 109/L; d) serum bilirubin \>25 µmol/L (1.5 mg/dL); e) liver function tests with values \>3 x upper limit of normal (ULN) f) serum creatinine \>1.5 x ULN or creatinine clearance \< 60 mL/minute
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Tolerated Dose (MTD) of Combination Treatment with Lenvatinib and Capecitabine in Advanced and/or Metastatic Cancer Refractory to Standard Treatment
. Positive history of HIV, active hepatitis B or active hepatitis C or severe/uncontrolled intercurrent illness or infection
. Centrally located non-small cell lung cancers and squamous cell lung cancers
. Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start
. Patients with marked Baseline prolongation of QT/QTc interval (QTc interval \> 450 msec for males or \> 470 msec for females) using the Fridericia method for QTc analysis
. Bleeding or thrombotic disorders, or using therapeutic dosages of anticoagulants, such as warfarin. Occasional use of NSAIDs and antiplatelet agents such as aspirin, clopidogrel, aggrenox and dipyridamole are not considered exclusionary if taken \<7 days per 28 days. However, if the patient requires chronic use (\>/=7 days out of 28 days) of full doses of aspirin or NSAIDs then the patient is excluded.
. Requirement for chronic use of full dose aspirin or non-steroidal anti-inflammatory drugs (NSAIDs)