Urinary Tract Cancer
Conditions
Brief summary
This study will evaluate the efficacy and safety of intravenous Herceptin in patients with metastatic urothelial cancer with disease progression during platinum-based chemotherapy. The anticipated time on study treatment is until disease progression.
Interventions
DRUGtrastuzumab
Initial dose of 4 mg/kg i.v on Day 1, followed by weekly doses of 2 mg/kg i.v. beginning on Day 8 and continuing for up to 37 weeks.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients \>=18 years of age; * metastatic urothelial cancer; * disease progression during or after 1 prior platinum-based chemotherapy; * measurable disease; * HER2 overexpression (IHC \[2+\] or \[3+\]).
Exclusion criteria
* concomitant chemotherapy or immunotherapy; * active or uncontrolled infection; * solely CNS metastases; * clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea; * co-existing malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) - Percentage of Participants With an Event | Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment | 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. |
| Progression-Free Survival - Time to Event | Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment | The median time, in months, from the first study drug treatment to a PFS event. |
| Percentage of Participants Progression Free at 12 and 24 Months | Months 12 and 24 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) - Percentage of Participants With an Event | Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter | OS was defined as the time from the start of study treatment to date of death due to any cause. |
| Percentage of Participants by Best Overall Response to Treatment | Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment | 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). |
| Overall Survival - Time to Event | Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter | The median time, in months, from the start of study treatment to an OS event. |
| Percentage of Participants Surviving at 12 and 24 Months | Months 12 and 24 | — |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Trastuzumab Monotherapy 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. | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Trial was terminated by sponsor | 1 |
Baseline characteristics
| Characteristic | Trastuzumab Monotherapy |
|---|---|
| Age, Continuous | 67.4 years STANDARD_DEVIATION 8.2 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 5 |
| serious Total, serious adverse events | 2 / 5 |
Outcome results
Primary
Percentage of Participants Progression Free at 12 and 24 Months
Time frame: Months 12 and 24
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trastuzumab Monotherapy | Percentage of Participants Progression Free at 12 and 24 Months | 12 Months | 20.0 percentage of participants |
| Trastuzumab Monotherapy | Percentage of Participants Progression Free at 12 and 24 Months | 24 Months | 20.0 percentage of participants |
Primary
Progression-Free Survival (PFS) - Percentage of Participants With an Event
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.
Time frame: Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trastuzumab Monotherapy | Progression-Free Survival (PFS) - Percentage of Participants With an Event | 80.0 percentage of participants |
Primary
Progression-Free Survival - Time to Event
The median time, in months, from the first study drug treatment to a PFS event.
Time frame: Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment
Population: FAS
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Trastuzumab Monotherapy | Progression-Free Survival - Time to Event | 2.5 months |
Secondary
Overall Survival (OS) - Percentage of Participants With an Event
OS was defined as the time from the start of study treatment to date of death due to any cause.
Time frame: Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trastuzumab Monotherapy | Overall Survival (OS) - Percentage of Participants With an Event | 80.0 percentage of participants |
Secondary
Overall Survival - Time to Event
The median time, in months, from the start of study treatment to an OS event.
Time frame: Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter
Population: FAS
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Trastuzumab Monotherapy | Overall Survival - Time to Event | 14.7 months |
Secondary
Percentage of Participants by Best Overall Response to Treatment
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).
Time frame: Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trastuzumab Monotherapy | Percentage of Participants by Best Overall Response to Treatment | SD | 20.0 percentage of participants |
| Trastuzumab Monotherapy | Percentage of Participants by Best Overall Response to Treatment | PD | 80.0 percentage of participants |
| Trastuzumab Monotherapy | Percentage of Participants by Best Overall Response to Treatment | SD/PD | 100.0 percentage of participants |
Secondary
Percentage of Participants Surviving at 12 and 24 Months
Time frame: Months 12 and 24
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trastuzumab Monotherapy | Percentage of Participants Surviving at 12 and 24 Months | 12 Months | 60.0 percentage of participants |
| Trastuzumab Monotherapy | Percentage of Participants Surviving at 12 and 24 Months | 24 Months | 20.0 percentage of participants |