A clinical trial to look at long-term safety of lenvatinib either alone or in combination with another drug, in patients with cancer.

Phase 1

• Conditions: solid tumors or lymphomas, as defined in parent protocol; MedDRA version: 21.1Level: PTClassification code 10055107Term: Thyroid cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10016935Term: Follicular thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10027105Term: Medullary thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10066474Term: Thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 24.0Level: PTClassification code 10033701Term: Papillary thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10025315Term: Lymphoma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-003668-11-RO
• Lead Sponsor: Eisai Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-13
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Provide signed written informed consent for the roll-over trial
2. Currently enrolled in an Eisai sponsored lenvatinib clinical trial and still receiving at least one of the study drugs from that protocol
3. Currently deriving clinical benefit from at least one of the study drug(s) as determined by the investigator
4. Must be able and willing to comply with the current role-over protocol requirements
5. Continued ability to swallow and retain orally administered study drug(s)
6. Does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
7. Women of childbearing potential and men with reproductive potential (if specified by the parent study) must be willing to continue to use highly effective methods of contraception control as per local practices of standard of care during the period of the study
8. Women of childbearing potential must have a negative serum pregnancy test at the time of transition to the study and before continuing study drug(s)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Permanent discontinuation of all study drug(s) in the parent trial due to toxicity or disease progression and without clinical benefit
2. Receiving any prohibited medication(s) as described in the parent trial
3. Any unresolved toxicity that meets the criteria for study drug(s) discontinuation or withdrawal criteria from the parent trial at the time of transition to this study
4. Uncontrolled diabetes, hypertension or other medical conditions at the time of transition to the roll-over trial that may interfere with assessment of toxicity
5. Pregnant or lactating female
6. Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to the roll-over trial that could interfere with subject's safety in the opinion of the investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to assess long-term safety of study drug(s) in subjects who are enrolled in Eisai-sponsored lenvatinib studies.;Secondary Objective: Not applicable;Primary end point(s): Safety assessments will consist of monitoring and recording all TEAEs, including all Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grades (for both increasing and decreasing severity), and SAEs. Long term safety information will be collected at the time drug is dispensed to the subject.<br>Monitoring of hematology, blood chemistry, and urine values; measurement of vital signs and performance of physical examinations should be performed per local standard of care or as clinically indicated.;Timepoint(s) of evaluation of this end point: All assessments for efficacy and safety will be performed as per local standard of care or as clinically indicated.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable