The primary objective is to assess long-term safety of study drug(s) in subjects who are enrolled in Eisai-sponsored lenvatinib studies.
ID
Source
Brief title
Condition
- Thyroid gland disorders
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The Safety Analysis Set is the group of subjects who received at least 1 dose
of study drug(s). The Safety Analysis Set will be used in all analyses of
safety. The following safety tables and listings will be available for review:
* Extent of exposure, TEAEs, SAEs, TEAEs/SAEs related to study drug(s), TEAEs
leading to discontinuation of study drug(s)/withdrawal, fatal TEAEs and deaths.
* Other TEAEs that the investigator deemed important to report and reasons for
discontinuation of study drug(s).
Secondary outcome
N/A
Background summary
This is an open-label extension study to roll-over eligible subjects from Eisai
sponsored lenvatinib studies. The subjects may roll-over no sooner than the
primary completion dates in their parent study or after all study data for
primary outcome measure were collected for the parent study.
The parent study is defined as the Eisai-sponsored lenvatinib clinical study in
which the subject was receiving lenvatinib either as monotherapy or as
combination therapy or was receiving any other comparator therapy. The subject
can be enrolled in the current study for purpose of long-term safety data
collection if all the selection criteria for the current study are met. The
intention is that the subject will not be without study drug during transition
from the parent study to the rollover study. The investigators must review the
*End of Treatment* assessments from the parent study prior to starting the
study drug(s) in the current study.
All treatment emergent adverse events (TEAEs) and serious adverse events
(SAEs), regardless of relationship to study drug or procedure, should be
recorded beginning from the time the subject signs the roll-over study ICF for
up to 28 days after last dose of study drug(s) (or 5 × half-life of study
drug[s], whichever is longer).
Study objective
The primary objective is to assess long-term safety of study drug(s) in
subjects who are enrolled in Eisai-sponsored lenvatinib studies.
Study design
After signing the consent form for the study and meeting all inclusion and
exclusion criteria, subjects will be assigned to a treatment cohort as
described below to continue treatment with study drug(s) in the study protocol.
Cohort A
Subjects who received lenvatinib monotherapy or who crossed over from a
comparator arm to receive lenvatinib monotherapy in their parent study will
continue to receive lenvatinib monotherapy
Cohort B
Subjects who received lenvatinib combination therapy or who crossed over from a
comparator arm to receive lenvatinib combination therapy in their parent study
will continue to receive lenvatinib combination therapy
Cohort C
Subjects who received comparator treatment in their parent study will continue
to receive comparator treatment,
Intervention
Subjects enrolled from parent study will enter the roll-over study and will
continue the study drug of lenvatinib, or combination regimen, or any other
comparator therapy at the same doses upon discontinuation of the parent study.
Study burden and risks
Lenvatinib
Serious Side Effects
Common (may affect up to 1 in 10 people)
* stroke, mini-stroke or bleeding on your brain - you may feel numb or weak on
one side of your body
* blood clot in your legs or lungs (pulmonary embolism) - may cause swelling of
the calf associated with warmth or tenderness, sudden onset of shortness of
breath, rapid breathing, tightening of chest or chest pain, cough or coughing
up blood, rapid heart rate and a blue tinge to the lips
* heart problems, such as heart failure, heart palpitations or heart attack -
may cause chest pain or pressure, pain in your arms, back, neck or jaw, being
short of breath, rapid or irregular heart rate, coughing, bluish colour to lips
or fingers, feeling very tired
* bowel fistula or perforation - severe pain in your belly (abdomen) - this may
be due to a hole in the wall of your gut or a fistula (a hole in your gut which
links through a tube-like passage to another part of your body or skin).
* bleeding inside your body particularly from the gut - may cause black, tarry,
or bloody stools
* dehydration and kidney failure - may result from diarrhoea, feeling and being
sick which are very common side effects
* heart failure - a decreased pumping ability of the heart which may cause
severe shortness of breath
Uncommon (may affect up to 1 in 100 people)
* posterior reversible encephalopathy syndrome (PRES) is a potentially fatal
condition that may have the following symptoms: headache, confusion,
convulsions and vision disturbance. An MRI scan may be required to diagnose
this condition.
* inflammation of the pancreas which may cause severe pain in the abdomen or
back
* liver injury- you may have yellowing of the skin or eyes (jaundice), feel
tired or sick, loss of appetite, abdominal pain or high temperature.
* other types of fistulae (an abnormal connection between an organ in the body
and the skin, or between an organ and another organ or structure such as throat
or windpipe)
Other Side Effects - Some May be Serious
Very Common (affects more than 1 in 10 people and up to 8 in 10 people)
• high or low blood pressure
• loss of appetite or weight loss
• feeling sick and being sick (vomiting), constipation, diarrhoea, abdominal
pain, indigestion
• feeling very tired or weak
• dry, sore, or inflamed mouth or throat
• high levels of protein in the urine
• hoarse voice
• headache
• hand-foot syndrome (redness, soreness and swelling of the skin on the hands
and feet)
• joint pains
• cough
• low level of platelets in the blood which may lead to bruising
• musculoskeletal, muscle, limb or back pain
• swelling of the legs due to fluid retention
• rash
• feeling dizzy
• bleeding (most commonly nose bleeds, but may include bleeding from other
sites such as blood in the urine, bruising, bleeding from the gums, coughing up
blood)
• odd taste sensation
• trouble sleeping
• hair loss
Common (may affect up to 1 in 10 people)
• loss of body fluids (dehydration)
• dry skin, thickening and itching of the skin
• feeling bloated or having gas in the bowel or indigestion
• feeling unwell
• inflammation of the gallbladder
• changes in blood test results for liver.
• changes in blood test results for magnesium (low) - may increase the chance
of having an abnormal heart rhythm
• changes in blood test results for kidney function
• changes in white blood cells ( low) which may increase risk of infections
• changes in blood test results (high) for lipase and amylase (enzymes involved
in digestion)
• low blood pressure
• urinary infections (increased frequency in urination and pain in passing
urine)
• Underactive thyroid and change in blood test result for thyroid stimulating
hormone (high) - may result in fatigue, weakness, dry skin, hair loss,
intolerance to cold
• changes in blood test results for potassium levels (low) or calcium levels
(low) - may increase the chance of having an abnormal heart rhythm
• Muscle weakness
• changes in blood test results for cholesterol (high)
Uncommon (may affect up to 1 in 100 people)
• painful infection or irritation near the anus
• splenic infarction (severe pain in the upper left part of the belly (abdomen)
which may be associated with fever, chills, nausea and vomiting)
Mosquito Way -
Hatfield AL10 9SN
GB
Mosquito Way -
Hatfield AL10 9SN
GB
Listed location countries
Age
Inclusion criteria
1. Currently enrolled in an Eisai sponsored lenvatinib clinical study and still receiving at least one
of the study drugs from that protocol
2. Currently deriving clinical benefit from at least one of the study drug(s) as determined by the
investigator
3. Must be able and willing to comply with the current roll-over protocol requirements
4. Continued ability to swallow and retain orally administered study drug(s)
5. Does not have any clinically significant gastrointestinal abnormalities that may alter absorption
such as malabsorption syndrome or major resection of the stomach or bowels
6. Women of childbearing potential must be willing to continue to use highly effective methods of contraception as per local practices of standard of care during the period of the study
7. 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)
Exclusion criteria
1. Permanent discontinuation of all study drug(s) in the parent study due to toxicity or disease
progression and without clinical benefit
2. Receiving any prohibited medication(s) as described in the parent study
3. Any unresolved toxicity that meets the criteria for study drug(s) discontinuation or withdrawal
criteria from the parent study 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 study that may interfere with assessment of toxicity
5. Pregnant or lactating female
6. Any serious and/or unstable pre-existing medical condition, psychiatric disorder or other
conditions at the time of transition to the roll-over study that could interfere with subject's safety
in the opinion of the investigator
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-003668-11-NL |
| CCMO | NL65013.031.18 |