Trial Outcomes & Findings for A Study of Herceptin (Trastuzumab) Monotherapy in Patients With Metastatic Urothelial Cancer (NCT NCT02013765)

NCT ID: NCT02013765

Last Updated: 2014-09-25

Results Overview

PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment
• Results posted on: 2014-09-25

Participant Flow

Participant milestones

Measure	Trastuzumab Monotherapy Participants received an initial dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
Overall Study STARTED	5
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Trastuzumab Monotherapy Participants received an initial dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
Overall Study Trial was terminated by sponsor	1

Baseline Characteristics

A Study of Herceptin (Trastuzumab) Monotherapy in Patients With Metastatic Urothelial Cancer

Baseline characteristics by cohort

Measure	Trastuzumab Monotherapy n=5 Participants Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
Age, Continuous	67.4 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment

Population: FAS

PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause.

Outcome measures

Measure	Trastuzumab Monotherapy n=5 Participants Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
Progression-Free Survival (PFS) - Percentage of Participants With an Event	80.0 percentage of participants

PRIMARY outcome

Timeframe: Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment

Population: FAS

The median time, in months, from the first study drug treatment to a PFS event.

Outcome measures

Measure	Trastuzumab Monotherapy n=5 Participants Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
Progression-Free Survival - Time to Event	2.5 months Interval 0.7 to Upper limit of the 95 percent (%) confidence interval (CI) could not be calculated as the follow-up time was too short to observe enough events for complete data estimation.

PRIMARY outcome

Timeframe: Months 12 and 24

Population: FAS

Outcome measures

Measure	Trastuzumab Monotherapy n=5 Participants Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
Percentage of Participants Progression Free at 12 and 24 Months 12 Months	20.0 percentage of participants Interval 0.8 to 58.2
Percentage of Participants Progression Free at 12 and 24 Months 24 Months	20.0 percentage of participants Interval 0.8 to 58.2

SECONDARY outcome

Timeframe: Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter

Population: FAS

OS was defined as the time from the start of study treatment to date of death due to any cause.

Outcome measures

Measure	Trastuzumab Monotherapy n=5 Participants Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
Overall Survival (OS) - Percentage of Participants With an Event	80.0 percentage of participants

SECONDARY outcome

Timeframe: Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter

Population: FAS

The median time, in months, from the start of study treatment to an OS event.

Outcome measures

Measure	Trastuzumab Monotherapy n=5 Participants Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
Overall Survival - Time to Event	14.7 months Interval 2.5 to Upper limit of the 95% CI could not be calculated as the follow-up time was too short to observe enough events for complete data estimation.

SECONDARY outcome

Timeframe: Months 12 and 24

Population: FAS

Outcome measures

Measure	Trastuzumab Monotherapy n=5 Participants Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
Percentage of Participants Surviving at 12 and 24 Months 12 Months	60.0 percentage of participants Interval 12.6 to 88.2
Percentage of Participants Surviving at 12 and 24 Months 24 Months	20.0 percentage of participants Interval 0.8 to 58.2

SECONDARY outcome

Timeframe: Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment

Population: FAS

Per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal [(short axis less than (<)10 millimeters (mm)]. No new lesions. Partial response (PR) was defined as greater than or equal to (≥)30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD) was defined as not qualifying for CR, PR, or progressive disease (PD).

Outcome measures

Measure	Trastuzumab Monotherapy n=5 Participants Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
Percentage of Participants by Best Overall Response to Treatment SD	20.0 percentage of participants
Percentage of Participants by Best Overall Response to Treatment PD	80.0 percentage of participants
Percentage of Participants by Best Overall Response to Treatment SD/PD	100.0 percentage of participants

Adverse Events

Trastuzumab Monotherapy

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Trastuzumab Monotherapy n=5 participants at risk Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
General disorders Pain - stomach	20.0% 1/5 • Adverse events (AEs) and serious adverse events (SAEs) were recorded from study start to 30 days after the last dose of study drug. All enrolled participants were included in the safety analysis.
Renal and urinary disorders Obstruction - GU	20.0% 1/5 • Adverse events (AEs) and serious adverse events (SAEs) were recorded from study start to 30 days after the last dose of study drug. All enrolled participants were included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.0% 1/5 • Adverse events (AEs) and serious adverse events (SAEs) were recorded from study start to 30 days after the last dose of study drug. All enrolled participants were included in the safety analysis.

Other adverse events

Measure	Trastuzumab Monotherapy n=5 participants at risk Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
General disorders Pain - extremity, limb	20.0% 1/5 • Adverse events (AEs) and serious adverse events (SAEs) were recorded from study start to 30 days after the last dose of study drug. All enrolled participants were included in the safety analysis.
General disorders Pain - headache	20.0% 1/5 • Adverse events (AEs) and serious adverse events (SAEs) were recorded from study start to 30 days after the last dose of study drug. All enrolled participants were included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.0% 1/5 • Adverse events (AEs) and serious adverse events (SAEs) were recorded from study start to 30 days after the last dose of study drug. All enrolled participants were included in the safety analysis.
Cardiac disorders Hypertension	20.0% 1/5 • Adverse events (AEs) and serious adverse events (SAEs) were recorded from study start to 30 days after the last dose of study drug. All enrolled participants were included in the safety analysis.
General disorders Constitutional symptoms - other (not specified)	20.0% 1/5 • Adverse events (AEs) and serious adverse events (SAEs) were recorded from study start to 30 days after the last dose of study drug. All enrolled participants were included in the safety analysis.
Gastrointestinal disorders Diarrhoea	20.0% 1/5 • Adverse events (AEs) and serious adverse events (SAEs) were recorded from study start to 30 days after the last dose of study drug. All enrolled participants were included in the safety analysis.
Infections and infestations Infection - other (not specified)	20.0% 1/5 • Adverse events (AEs) and serious adverse events (SAEs) were recorded from study start to 30 days after the last dose of study drug. All enrolled participants were included in the safety analysis.
Infections and infestations Infection with unknown absolute neutrophil count (ANC)	20.0% 1/5 • Adverse events (AEs) and serious adverse events (SAEs) were recorded from study start to 30 days after the last dose of study drug. All enrolled participants were included in the safety analysis.
Metabolism and nutrition disorders Metabolic/laboratory - other (not specified)	20.0% 1/5 • Adverse events (AEs) and serious adverse events (SAEs) were recorded from study start to 30 days after the last dose of study drug. All enrolled participants were included in the safety analysis.

Additional Information

Medical Communications

Hoffman-LaRoche

Phone: 800-821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER