Trial Outcomes & Findings for Trial to Evaluate Safety and Efficacy of Treatment of Physician Choice (TPC) Following First-Line Treatment of Lenvatinib in Subjects With Unresectable Hepatocellular Carcinoma (uHCC) (NCT NCT03433703)
NCT ID: NCT03433703
Last Updated: 2019-12-06
Results Overview
TERMINATED
PHASE2
8 participants
From the first dose of study drug up to 28 days after the last dose of study drug (approximately 3 months)
2019-12-06
Participant Flow
Participants took part in the study at 3 investigative sites in the United States from 26 April 2018 to 07 January 2019.
A total of 8 participants were enrolled, of these, 6 were screen failures and 2 were treated. Upon completion of lenvatinib treatment, eligible participants were to receive commercially available systemic treatment of physician choice (TPC). However, because of early termination of study no participants received TPC.
Participant milestones
| Measure |
Lenvatinib
Participants received lenvatinib 8 or 12 milligram (mg), capsule, orally, once daily in 28 day continuous cycles until disease progression (PD), development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor. Body weight (BW) greater than or equal to (\>=) 60 kilograms (kg) - lenvatinib 12 mg (taken as three 4 mg capsules); BW less than (\<) 60 kg - lenvatinib 8 mg (taken as two 4 mg capsules).
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|---|---|
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Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Lenvatinib
Participants received lenvatinib 8 or 12 milligram (mg), capsule, orally, once daily in 28 day continuous cycles until disease progression (PD), development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor. Body weight (BW) greater than or equal to (\>=) 60 kilograms (kg) - lenvatinib 12 mg (taken as three 4 mg capsules); BW less than (\<) 60 kg - lenvatinib 8 mg (taken as two 4 mg capsules).
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|---|---|
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Overall Study
Study terminated by Sponsor
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2
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Baseline Characteristics
Trial to Evaluate Safety and Efficacy of Treatment of Physician Choice (TPC) Following First-Line Treatment of Lenvatinib in Subjects With Unresectable Hepatocellular Carcinoma (uHCC)
Baseline characteristics by cohort
| Measure |
Lenvatinib
n=2 Participants
Participants received lenvatinib 8 or 12 mg, capsule, orally, once daily in 28 day continuous cycles until PD, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor. BW \>=60 kg - lenvatinib 12 mg (taken as three 4 mg capsules); BW \<60 kg - lenvatinib 8 mg (taken as two 4 mg capsules).
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
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1 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: From the first dose of study drug up to 28 days after the last dose of study drug (approximately 3 months)Population: The safety analysis set (full analysis set) included all participants who received at least 1 dose of the lenvatinib treatment.
Outcome measures
| Measure |
Lenvatinib
n=2 Participants
Participants received lenvatinib 8 or 12 mg, capsule, orally, once daily in 28 day continuous cycles until PD, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor. BW \>=60 kg - lenvatinib 12 mg (taken as three 4 mg capsules); BW \<60 kg - lenvatinib 8 mg (taken as two 4 mg capsules).
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|---|---|
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
1 Participants
|
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
1 Participants
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SECONDARY outcome
Timeframe: From first dose date until date of death from any cause (approximately 3 months)Population: The safety analysis set (full analysis set) included all participants who received at least 1 dose of the lenvatinib treatment.
OS is defined as the time from the date of first dose of study treatment to the date of death from any cause. Participants who are lost to follow-up are censored at the last date the participant was known to be alive, and participants who remain alive are censored at the time of data cutoff. OS was to be calculated using Kaplan-Meier estimate and presented with 2-sided 95% confidence interval.
Outcome measures
| Measure |
Lenvatinib
n=2 Participants
Participants received lenvatinib 8 or 12 mg, capsule, orally, once daily in 28 day continuous cycles until PD, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor. BW \>=60 kg - lenvatinib 12 mg (taken as three 4 mg capsules); BW \<60 kg - lenvatinib 8 mg (taken as two 4 mg capsules).
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|---|---|
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Overall Survival (OS)
|
NA months
Data from pre-specified Kaplan Meier estimation cannot be reported, because of insufficient number of participants with events.
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SECONDARY outcome
Timeframe: From first dose date until PD or date of death from any cause (approximately 3 months)Population: The safety analysis set (full analysis set) included all participants who received at least 1 dose of the lenvatinib treatment.
PFS based on modified Response Evaluation Criteria in Solid Tumors (mRECIST) (and including the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 conventions for non-hepatic lesions) is defined as the time from the date of the first dose of first-line lenvatinib treatment to the date of the first documentation of PD, or the date of death during the subsequent systemic TPC, whichever occurs first. PD is defined at least 20% increase (including an absolute increase of at least 5 millimeter \[mm\]) in the sum of diameters of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was to be calculated using Kaplan-Meier estimate and presented with 2-sided 95% confidence interval.
Outcome measures
| Measure |
Lenvatinib
n=2 Participants
Participants received lenvatinib 8 or 12 mg, capsule, orally, once daily in 28 day continuous cycles until PD, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor. BW \>=60 kg - lenvatinib 12 mg (taken as three 4 mg capsules); BW \<60 kg - lenvatinib 8 mg (taken as two 4 mg capsules).
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|---|---|
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Progression-free Survival (PFS)
|
NA months
Data from pre-specified Kaplan Meier estimation cannot be reported, because of insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From first dose date until PD (approximately 3 months)Population: The safety analysis set (full analysis set) included all participants who received at least 1 dose of the lenvatinib treatment.
TTP based on mRECIST (and including the RECIST 1.1 conventions for non-hepatic lesions) is defined as the time from the date of the first dose of first-line lenvatinib treatment to the date of the first documentation of disease progression during subsequent systemic TPC. PD is defined at least 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. TTP was to be calculated using Kaplan-Meier estimate and presented with 2-sided 95% confidence interval.
Outcome measures
| Measure |
Lenvatinib
n=2 Participants
Participants received lenvatinib 8 or 12 mg, capsule, orally, once daily in 28 day continuous cycles until PD, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor. BW \>=60 kg - lenvatinib 12 mg (taken as three 4 mg capsules); BW \<60 kg - lenvatinib 8 mg (taken as two 4 mg capsules).
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|---|---|
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Time to Progression (TTP)
|
NA months
Data from pre-specified Kaplan Meier estimation cannot be reported, because of insufficient number of participants with events.
|
Adverse Events
Lenvatinib
Serious adverse events
| Measure |
Lenvatinib
n=2 participants at risk
Participants received lenvatinib 8 or 12 mg, capsule, orally, once daily in 28 day continuous cycles until PD, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor. BW \>=60 kg - lenvatinib 12 mg (taken as three 4 mg capsules); BW \<60 kg - lenvatinib 8 mg (taken as two 4 mg capsules).
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|---|---|
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Nervous system disorders
Hepatic encephalopathy
|
50.0%
1/2 • From the first dose of study drug up to 28 days after the last dose of study drug (approximately 3 months)
|
Other adverse events
| Measure |
Lenvatinib
n=2 participants at risk
Participants received lenvatinib 8 or 12 mg, capsule, orally, once daily in 28 day continuous cycles until PD, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor. BW \>=60 kg - lenvatinib 12 mg (taken as three 4 mg capsules); BW \<60 kg - lenvatinib 8 mg (taken as two 4 mg capsules).
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|---|---|
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Infections and infestations
Urinary tract infection
|
50.0%
1/2 • From the first dose of study drug up to 28 days after the last dose of study drug (approximately 3 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
50.0%
1/2 • From the first dose of study drug up to 28 days after the last dose of study drug (approximately 3 months)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
50.0%
1/2 • From the first dose of study drug up to 28 days after the last dose of study drug (approximately 3 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place