An Open-Label, Non-Randomized, Single-Center Study to Determine the Metabolism and Elimination of 14C-E7080 in Patients with Advanced Solid Tumors or Lymphomas, who are Unsuitable For, or Have Failed, Existing Therapies

• Conditions: Cancer; 10027656; Drug Metabolism

• Registration Number: NL-OMON33844
• Lead Sponsor: Eisai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Patients with histologically and/or cytologically confirmed solid tumor or lymphoma who are resistant/ refractory to approved therapies or for whom no appropriate therapies are available. Patients with measurable tumors according to RECIST are desirable but not essential for inclusion.
2. All previous treatment (including surgery and radiotherapy) must have been completed at least four weeks prior to study entry and any acute toxicity must have resolved
3. Aged >= 18 years
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
5. Able to take oral study medication
6. Give written informed consent to participate in the study
7. Willing and able to comply with the study protocol for the duration of the study.

Exclusion Criteria

1. Patients with brain or subdural metastases, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs and/or symptoms of brain metastases must be stable for at least 4 weeks.
2. Patients with meningeal carcinomatosis
3. Any of the following values for 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) PT (or INR) and PTT > 1.5 x the upper limit of normal (ULN)
e) serum bilirubin >1.5 x ULN
f) other liver parameters >3 x ULN
g) creatinine clearance < 60 mL/min per the Cockcroft and Gault formula
4. Uncontrolled infections
5. Significant cardiovascular impairment (history of congestive heart failure > NYHA Class II, unstable ischemic heart disease including a myocardial infarction within six months of study start, or serious cardiac arrhythmia)
6. Patients with marked baseline prolongation of QT/QTc interval (QTc interval >= 500 msec) using the Fridericia method
7. Any treatment with an investigational drug within the last 30 days
8. Women who are pregnant or breast-feeding;women of childbearing potential with a positive pregnancy test at screening or no pregnancy test. Women of child-bearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator (including two forms of contraception, one of which must be a barrier method). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-child-bearing potential. Fertile males with female partners of child-bearing potential who are not willing to use contraception, or whose female partners are not using adequate contraceptive protection, are excluded.
9. Proteinuria > 1+ on bedside testing
10. History of gastrointestinal malabsorption
11. Surgery within four weeks of start of study treatment
12. Bleeding or thrombotic disorders or use of an anticoagulant, such as warfarin, with a therapeutic international normalization ratio (INR). Aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), and low molecular weight heparin (LMWH) are permissible but should be used with caution.
13. Poorly controlled hypertension (defined as a change in hypertensive therapy within three months of study start) or patients diagnosed with hypertension (defined as a repeat blood pressure measurement of 160/90 mmHg or higher) at screening
14. Previous E7080 therapy
15. History of alcoholism, drug addiction, psychiatric or psychological condition, or social situation which, in the opinion of the investigator, would impair study compliance
16. History of allergic reactions attributed to compounds of similar chemical or biological composition to E7080
17. Other significant disease or disorder that, in the Investigator*s opinion, would exclude the patient from the study
18. Legal incapacity

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Plasma, urine, and fecal concentrations of 14C-E7080 related material, and its<br /><br>metabolites will be evaluated after the first dose of 14C E7080 to determine<br /><br>the timing, extent and pathway of elimination of the drug.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Baseline characteristics, adverse events, serious adverse events, laboratory<br /><br>parameters, and other safety parameters </p><br>