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 range18 Years
SexALL
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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
✕. 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
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
. 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)