| Primary | Lead-In Part: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03) | DLTs as per NCI CTCAE v4.03 were defined as 1) serious infusion reaction (CTCAE) Grade 4 adverse event of "Infusion related reaction," or recurrent CTCAE Grade 3 despite administration of systemic steroid premedication after initial occurrence. Infusion reactions were defined as symptoms (example, fatigue, nausea, vomiting, arthralgia, myalgia, pyrexia, chills, rigors) occurring within 24 hours of E7777 infusion. 2) Capillary leak syndrome (CLS) CTCAE Grade 4 or Grade 3 (with exceptions). A CLS event was defined as the noted occurrence of at least 2 of the following: hypotension, edema, or serum albumin less than (<) 3.0 gram per decilitre (g/dL). 3) Clinical visual impairment. 4) Any CTCAE Grade greater than or equal to (>=) 4 adverse event (AE) that may represent an infusion reaction. 5) Any other Grade 3 or greater toxicity assessed as related to E7777 treatment and which in the opinion of a safety consultancy investigator panel, was a dose-limiting toxicity. | Lead-in analysis set included all participants enrolled in lead-in part. | Posted | | Count of Participants | | Participants | | Cycle 1 (cycle length was 21 days) | | | | ID | Title | Description |
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| OG000 | Lead-In Part: E7777 6 mcg/kg | Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part. | | OG001 | Lead-In Part: E7777 9 mcg/kg | Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part. | | OG002 | Lead-In Part: E7777 12 mcg/kg | Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part. | | OG003 | Lead-In Part: E7777 15 mcg/kg | Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part. |
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| Primary | Lead-In Part: Maximum Tolerated Dose (MTD) of E7777 | The MTD was defined as the safe dose level established in Lead-In Part. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the Lead-In Part. | Dose-finding analysis set included all participants in the Lead-in part who completed Cycle 1 treatment and were evaluated for DLT, and those who discontinued during Cycle 1 due to DLT. | Posted | | Number | | mcg/kg | | Cycle 1 (cycle length was 21 days) | | | | ID | Title | Description |
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| OG000 | Lead-In Part: E7777 | Participants were treated with E7777 6, 9, 12 and 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In part. |
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| Primary | Main Study Part: Objective Response Rate (ORR) by Independent Review Committee (IRC) Based on Olsen 2011 Criteria | ORR was defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) based on independent review committee on 2 assessments at least 3 weeks apart. The tumor response was based on global response score (GRS) Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. | Primary efficacy analysis set included all participants with Stages I to III CTCL (both Main Study and Lead-In part) who received study drug at the 9 mcg/kg dose | Posted | | Number | 95% Confidence Interval | percentage of participants | | From the date of administration of the first dose of the study drug until disease progression (Up to 3 years 6 months) | | | | ID | Title | Description |
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| OG000 | Main Study Part: E7777 9 mcg/kg | Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned. |
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| Secondary | Lead-In Part: Duration of Response (DOR) Per Investigator Assessment | DOR per investigator assessment was defined as the time from date when criteria for response (CR or PR) was first met until the date of the first documentation of disease progression (PD) or date of death from any cause. The tumor assessment was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. PD was defined as any new lesion or unequivocally increase of previously involved sites from nadir. | Lead-in analysis set included all participants enrolled in the Lead-in part. Here, 'overall number of participants analyzed' were those who had CR or PR in lead in part. | Posted | | Median | Full Range | days | | From the date of first documentation of CR or PR until date of the first documentation of PD or death due to any cause (Up to 1 year 2 months) | | | | ID | Title | Description |
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| OG000 | Lead-In Part: E7777 6 mcg/kg | Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part. | | OG001 | Lead-In Part: E7777 9 mcg/kg | Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part. |
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| Secondary | Main Study Part: Duration of Response (DOR) Per Independent Review Committee | DOR per independent review committee was defined as the time from the date when criteria for response (CR or PR) was first met until the date of the first documentation of PD or date of death from any cause. The tumor assessment was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. PD was defined as any new lesion or unequivocally increase of previously involved sites from nadir. | Primary efficacy analysis set included all participants with Stages I to III CTCL (both Main Study and Lead-In part) who received study drug at the 9 mcg/kg dose. Here, 'overall number of participants analyzed' were those who had CR or PR in Lead-in part and in Main study part. | Posted | | Median | Full Range | months | | From the date of first documentation of CR or PR until date of the first documentation of PD or death due to any cause (Up to 3 years 6 months) | | | | ID | Title | Description |
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| OG000 | Main Study Part: E7777 9 mcg/kg | Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned. |
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| Secondary | Lead-In Part: Time to Response (TTR) Per Investigator Assessment | Time to response per investigator assessment was defined as the time from date of first dose to the date of the first documented CR or PR. The tumor assessment was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. | Lead-in analysis set included all participants enrolled in the Lead-in part. Here, 'overall number of participants analyzed' were those who had CR or PR in lead-in part of the study. | Posted | | Median | Full Range | days | | From the date of administration of the first dose of the study drug until date of the first documentation of PR or CR (Up to 1 year 2 months) | | | | ID | Title | Description |
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| OG000 | Lead-In Part: E7777 6 mcg/kg | Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part. | | OG001 | Lead-In Part: E7777 9 mcg/kg | Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part. | | OG002 | Lead-In Part: E7777 12 mcg/kg |
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| Secondary | Main Study Part: Time to Response (TTR) Per Independent Review Committee | Time to response per independent review committee was defined as the time from date of first dose to the date of the first documented CR or PR. The tumor assessment was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. | Primary efficacy analysis set included all participants with Stages I to III CTCL (both Main Study and Lead-In part) who received study drug at the 9 mcg/kg dose. Here, 'overall number of participants analyzed' were those who had CR or PR in Lead-in part and in Main study part. | Posted | | Median | Full Range | months | | From the date of administration of the first dose of the study drug until date of the first documentation of PR or CR (Up to 3 years 6 months) | | | | ID | Title | Description |
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| OG000 | Main Study Part: E7777 9 mcg/kg | Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned. |
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| Secondary | Lead-In Part and Main Study Part: ORR Per Investigator Assessment | ORR per investigator assessment was defined as the percentage of participants whose BOR was CR or PR. The tumor response was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. | Lead-in analysis set included all participants enrolled in the lead-in part and Investigator efficacy analysis set included all Stage I to III participants (both Main Study [n=66] and Lead-In [n=5]) who received study drug at 9 mcg/kg dose. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From the date of administration of the first dose of the study drug until disease progression (Up to 3 years 6 months) | | | | ID | Title | Description |
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| OG000 | Lead-In Part: E7777 6 mcg/kg | Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part. | | OG001 | Lead-In Part: E7777 9 mcg/kg | Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part. | | OG002 | Lead-In Part: E7777 12 mcg/kg |
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| Secondary | Main Study Part: ORR Per IRC Based on Prince 2010 Criteria | ORR was defined as the percentage of participants whose BOR was CR, clinical complete response (CCR) or PR per IRC. The tumor response was based on Prince 2010 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. CCR was defined as tumor residue not visible on esophagogram, computed tomography (CT), endoscopy, positron emission tomography (PET)-CT. | Primary efficacy analysis set included all participants with Stages I to III CTCL (both Main Study and Lead-In part) who received study drug at the 9 mcg/kg dose. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From the date of administration of the first dose of the study drug until disease progression (Up to 3 years 6 months) | | | | ID | Title | Description |
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| OG000 | Main Study Part: E7777 9 mcg/kg | Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned. |
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| Secondary | Lead-In Part and Main Study Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAE was defined as an adverse event that had an onset date, or a worsening in severity on or after the first dose of study drug up to the end of the study. SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening required inpatient hospitalization; resulted in persistent, significant disability; was congenital anomaly/birth defect or medically important due to other reasons than mentioned criteria. Number of participants with TEAEs and SAEs were reported. | Lead-In Part: SAS included all participants who received study drug. Main Study Part: SAS included all participants (both Main Study and Lead-In) who received study drug at 9 mcg/kg. | Posted | | Count of Participants | | Participants | | From the first dose of study drug up to 30 days after the last dose (Up to 3 years and 7 months) | | | | ID | Title | Description |
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| OG000 | Lead-In Part: E7777 6 mcg/kg | Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part. | | OG001 | Lead-In Part: E7777 12 mcg/kg | Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part. |
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| Secondary | Lead-In Part: Maximum Serum Concentration (Cmax) of E7777 | Participants were not available for analysis in 15 mcg/kg (Cycles 3 and 5), 6 mcg/kg (Cycle 5), 9 mcg/kg (Cycles 3 and 5), 12 mcg/kg (Cycle 3), hence no Pharmacokinetic (PK) data was collected and analyzed for these doses and cycles. | Lead-in PK analysis set included all participants who received at least one dose of study drug and from whom at least one valid E7777 PK parameter was obtained. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure for given timepoints. | Posted | | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | | Cycles 1, 3, 5 Day 1: Pre-dose up to 300 minutes post-dose (Cycle length was 21 days) | | | | ID | Title | Description |
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| OG000 | Lead-In Part: E7777 6 mcg/kg | Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part. | | OG001 | Lead-In Part: E7777 9 mcg/kg | Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part. | | OG002 |
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| Secondary | Main Study Part: Maximum Serum Concentration (Cmax) of E7777 | | Main study part PK analysis set included all participants from whom at least one quantifiable concentration of E7777 was observed at 9 mcg/kg dose (both Main Study and Lead-In). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given timepoints. | Posted | | Mean | Standard Deviation | ng/mL | | Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 minutes post-dose (Cycle length was 21 days) | | | | ID | Title | Description |
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| OG000 | Main Study Part: E7777 9 mcg/kg | Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned. |
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| Secondary | Lead-In Part: Area Under the Curve From Time 0 to Time t (AUC[0-t]) of E7777 | Participants were not available for analysis in 15 mcg/kg (Cycles 3 and 5), 6 mcg/kg (Cycle 5), 9 mcg/kg (Cycles 3 and 5), 12 mcg/kg (Cycle 3), hence no PK data was collected and analyzed for these doses and cycles. Here, min*ng/mL means minute*nanogram per milliliter. | Lead-in PK analysis set included all participants who received at least one dose of study drug and from whom at least one valid E7777 PK parameter was obtained. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure for given timepoints. | Posted | | Mean | Standard Deviation | min*ng/mL | | Cycles 1, 3, 5 Day 1: Pre-dose up to 300 hours Post-dose (Cycle length was 21 days) | | | | ID | Title | Description |
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| OG000 | Lead-In Part: E7777 6 mcg/kg | Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part. | | OG001 | Lead-In Part: E7777 9 mcg/kg | Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part. | |
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| Secondary | Main Study Part: Area Under the Curve From Time 0 to Time t (AUC[0-t]) of E7777 | | Main study part PK analysis set included all participants from whom at least one quantifiable concentration of E7777 was observed at 9 mcg/kg dose (both Main Study and Lead-In). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points. | Posted | | Mean | Standard Deviation | min*ng/mL | | Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days) | | | | ID | Title | Description |
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| OG000 | Main Study Part: E7777 9 mcg/kg | Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned. |
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| Secondary | Lead-In Part: Area Under the Curve From Time 0 to Time Infinity (AUC[0-inf]) of E7777 | Participants were not available for analysis in 15 mcg/kg (Cycles 3 and 5), 6 mcg/kg (Cycle 5), 9 mcg/kg (Cycles 3 and 5), 12 mcg/kg (Cycle 3), hence no PK data was collected and analyzed for these doses and cycles. | Lead-in PK analysis set included all participants who received at least one dose of study drug and from whom at least one valid E7777 PK parameter was obtained. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure for given timepoints. | Posted | | Mean | Standard Deviation | min*ng/mL | | Cycles 1, 3, 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days) | | | | ID | Title | Description |
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| OG000 | Lead-In Part: E7777 6 mcg/kg | Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part. | | OG001 | Lead-In Part: E7777 9 mcg/kg | Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part. | | OG002 |
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| Secondary | Main Study Part: Area Under the Curve From Time 0 to Time Infinity (AUC[0-inf]) of E7777 | Participants were not available for analysis at Cycle 3 Day 1, hence no PK data was collected and analyzed for this timepoint. | Main study part PK analysis set included all participants from whom at least one quantifiable concentration of E7777 was observed at 9 mcg/kg dose (both Main Study and Lead-In). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points. | Posted | | Mean | Standard Deviation | min*ng/mL | | Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days) | | | | ID | Title | Description |
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| OG000 | Main Study Part: E7777 9 mcg/kg | Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned. |
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| Secondary | Lead-In Part: Terminal Elimination Half-life (t1/2) of E7777 | Participants were not available for analysis in 15 mcg/kg (Cycles 3 and 5), 6 mcg/kg (Cycle 5), 9 mcg/kg (Cycles 3 and 5), 12 mcg/kg (Cycle 3), hence no PK data was collected and analyzed for these doses and cycles. | Lead-in PK analysis set included all participants who received at least one dose of study drug and from whom at least one valid E7777 PK parameter was obtained. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure for given timepoints. | Posted | | Median | Full Range | minutes | | Cycles 1, 3, 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days) | | | | ID | Title | Description |
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| OG000 | Lead-In Part: E7777 6 mcg/kg | Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part. | | OG001 | Lead-In Part: E7777 9 mcg/kg | Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part. | | OG002 | Lead-In Part: E7777 12 mcg/kg |
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| Secondary | Main Study Part: Terminal Elimination Half-life (t1/2) of E7777 | | Main study part PK analysis set included all participants from whom at least one quantifiable concentration of E7777 was observed at 9 mcg/kg dose (both Main Study and Lead-In). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points. | Posted | | Median | Full Range | minutes | | Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days) | | | | ID | Title | Description |
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| OG000 | Main Study Part: E7777 9 mcg/kg | Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned. |
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| Secondary | Lead-In Part: Time to Reach Maximum (Peak) Concentration After Drug Administration (Tmax) | Participants were not available for analysis in 15 mcg/kg (Cycles 3 and 5), 6 mcg/kg (Cycle 5), 9 mcg/kg (Cycles 3 and 5), 12 mcg/kg (Cycle 3), hence no PK data was collected and analyzed for these doses and cycles. | Lead-in PK analysis set included all participants who received at least one dose of study drug and from whom at least one valid E7777 PK parameter was obtained. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure for given timepoints. | Posted | | Median | Full Range | minute | | Cycles 1, 3, 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days) | | | | ID | Title | Description |
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| OG000 | Lead-In Part: E7777 6 mcg/kg | Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part. | | OG001 | Lead-In Part: E7777 9 mcg/kg | Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part. | | OG002 |
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| Secondary | Main Study Part: Time to Reach Maximum (Peak) Concentration After Drug Administration (Tmax) | | Main study part PK analysis set included all participants from whom at least one quantifiable concentration of E7777 was observed at 9 mcg/kg dose (both Main Study and Lead-In). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points. | Posted | | Median | Full Range | minutes | | Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days) | | | | ID | Title | Description |
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| OG000 | Main Study Part: E7777 9 mcg/kg | Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned. |
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| Secondary | Lead-In Part: Total Body Clearance (CL) of E7777 | Participants were not available for analysis in 15 mcg/kg (Cycles 3 and 5), 6 mcg/kg (Cycle 5), 9 mcg/kg (Cycles 3 and 5), 12 mcg/kg (Cycle 3), hence no PK data was collected and analyzed for these doses and cycles. Here, mL/min/kg means milliliter per minute per kilogram. | Lead-in PK analysis set included all participants who received at least one dose of study drug and from whom at least one valid E7777 PK parameter was obtained. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure for given timepoints. | Posted | | Mean | Standard Deviation | mL/min/kg | | Cycles 1, 3, 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days) | | | | ID | Title | Description |
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| OG000 | Lead-In Part: E7777 6 mcg/kg | Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part. | | OG001 | Lead-In Part: E7777 9 mcg/kg | Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part. | | OG002 |
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| Secondary | Main Study Part: Total Body Clearance (CL) of E7777 | Participants were not available for analysis at Cycle 3 Day 1, hence no PK data was collected and analyzed for this timepoint. | Main study part PK analysis set included all participants from whom at least one quantifiable concentration of E7777 was observed at 9 mcg/kg dose (both Main Study and Lead-In). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure for given time points. | Posted | | Mean | Standard Deviation | mL/min/kg | | Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days) | | | | ID | Title | Description |
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| OG000 | Main Study Part: E7777 9 mcg/kg | Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned. |
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| Secondary | Lead-In Part: Volume of Distribution at Steady State (Vdss) of E7777 | Participants were not available for analysis in 15 mcg/kg (Cycles 3 and 5), 6 mcg/kg (Cycle 5), 9 mcg/kg (Cycles 3 and 5), 12 mcg/kg (Cycle 3), hence no PK data was collected and analyzed for these doses and cycles. | Lead-in PK analysis set included all participants who received at least one dose of study drug and from whom at least one valid E7777 PK parameter was obtained. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure for given timepoints. | Posted | | Mean | Standard Deviation | milliliter per kilogram (mL/kg) | | Cycles 1, 3, 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days) | | | | ID | Title | Description |
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| OG000 | Lead-In Part: E7777 6 mcg/kg | Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part. | | OG001 | Lead-In Part: E7777 9 mcg/kg | Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part. | | OG002 |
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| Secondary | Main Study Part: Volume of Distribution at Steady State (Vdss) of E7777 | Participants were not available for analysis at Cycle 3 Day 1, hence no PK data was collected and analyzed for this timepoint. | Main study part PK analysis set included all participants from whom at least one quantifiable concentration of E7777 was observed at 9 mcg/kg dose (both Main Study and Lead-In). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure for given time points. | Posted | | Mean | Standard Deviation | milliliter (mL) | | Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days) | | | | ID | Title | Description |
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| OG000 | Main Study Part: E7777 9 mcg/kg | Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned. |
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| Secondary | Lead-In Part: Percentage of Participants Testing Positive for Anti-E7777 and Anti-interleukin (IL)-2 Antibodies | Immunogenicity was assessed by determining the anti-E7777 and anti-IL-2 antibodies in serum using validated methods. Percentage of participants testing positive for Anti-E7777 and Anti-IL-2 antibodies were reported. | Lead-in PK Analysis Set included all participants who received at least one dose of study drug and from whom at least one valid E7777 PK parameter was obtained. | Posted | | Number | | percentage of participants | | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1 | | | | ID | Title | Description |
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| OG000 | Lead-In Part: E7777 6 mcg/kg | Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part. | | OG001 | Lead-In Part: E7777 9 mcg/kg | Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part. | | OG002 | Lead-In Part: E7777 12 mcg/kg | Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part. |
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| Secondary | Main Study Part: Percentage of Participants Testing Positive for Anti-E7777 and Anti-IL-2 Antibodies | Immunogenicity was assessed by determining the anti-E7777 and anti-IL-2 antibodies in serum using validated methods. Percentage of participants testing positive for Anti-E7777 and Anti-IL-2 antibodies were reported. | Main Study Part PK Analysis Set included all participants from whom at least one quantifiable concentration of E7777 was observed at 9 mcg/kg dose (both Main Study and Lead-In). | Posted | | Number | | percentage of participants | | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1 | | | | ID | Title | Description |
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| OG000 | Main Study Part: E7777 9 mcg/kg | Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned. |
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| Secondary | Main Study Part: Number of Participants With Objective Skin Response | Modified severity weighted assessment tool (mSWAT) was used to measure skin disease severity based on the percentage of body surface area (BSA) with patches, plaques, or tumors. Total scores were calculated by multiplying the BSA percentage for each category of lesion (patch, plaque, or tumor) by a weighting factor and adding the three sub-scores which ranged from 0 (unaffected) to 400 (severely affected). Lower scores indicated a lower degree of skin disease severity. CR corresponded to 100% clearance of skin lesions present at baseline (mSWAT score of 0). PR corresponded to 50-99% clearance of skin disease present at baseline (at least 50% reduction in mSWAT score), without new tumors. | Primary efficacy analysis set included all participants with Stages I to III CTCL (both Main Study and Lead-In part) who received study drug at the 9 mcg/kg dose. | Posted | | Count of Participants | | Participants | | Up to 30 months | | | | ID | Title | Description |
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| OG000 | Main Study Part: E7777 9 mcg/kg | Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned. |
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| Secondary | Main Study Part: Duration of Skin Response | The duration of skin response based on the mSWAT score was defined as time from the date when criteria for skin response (CR or PR) was first met until the date of documented PD or death due to any cause for those participants with a confirmed PR or CR. mSWAT was used to measure skin disease severity based on the percentage of BSA with patches, plaques, or tumors. Total scores were calculated by multiplying the BSA percentage for each category of lesion (patch, plaque, or tumor) by a weighting factor and adding the three sub-scores which ranged from 0 (unaffected) to 400 (severely affected). Lower scores indicated a lower degree of skin disease severity. CR corresponded to 100% clearance of skin lesions present at baseline (mSWAT score of 0). PR corresponded to 50-99% clearance of skin disease present at baseline (at least 50% reduction in mSWAT score), without new tumors. | Primary efficacy analysis set included all participants with Stages I to III CTCL (both Main Study and Lead-In part) who received study drug at the 9 mcg/kg dose. Here 'overall number of participants analyzed' were those who had a skin response. | Posted | | Median | Full Range | months | | Up to 30 months | | | | ID | Title | Description |
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| OG000 | Main Study Part: E7777 9 mcg/kg | Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned. |
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| Secondary | Main Study Part: Time to Skin Response | The time to skin response based on the mSWAT score was defined as time from the date of first dose to the date when criteria for skin response (CR or PR) were first met. mSWAT was used to measure skin disease severity based on the percentage of BSA with patches, plaques, or tumors. Total scores were calculated by multiplying the BSA percentage for each category of lesion (patch, plaque, or tumor) by a weighting factor and adding the three sub-scores which ranged from 0 (unaffected) to 400 (severely affected). Lower scores indicated a lower degree of skin disease severity. CR corresponded to 100% clearance of skin lesions present at baseline (mSWAT score of 0). PR corresponded to 50-99% clearance of skin disease present at baseline (at least 50% reduction in mSWAT score), without new tumors. | Primary efficacy analysis set included all participants with Stages I to III CTCL (both Main Study and Lead-In part) who received study drug at the 9 mcg/kg dose. Here 'overall number of participants analyzed' were those who had a skin response. | Posted | | Median | Full Range | months | | Up to 30 months | | | | ID | Title | Description |
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| OG000 | Main Study Part: E7777 9 mcg/kg | Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned. |
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