Clinical Trial Result Information

Title of Study:
An open-label pilot Phase II trial of Herceptin (trastuzumab) (humanized anti-HER2 antibody) administered as monotherapy in patients with HER2-overexpressing metastatic or locally advanced Transitional Cell Carcinoma of the Bladder (TCC)

Fast Facts:

Protocol number:	M77502
Sponsor:	Roche Pharma (Schweiz) AG
Company division:	Pharmaceutical
Product name:	Herceptin
Generic name:	trastuzumab
Phase of development:	II
Therapeutic area, approved indication:	Bladder Cancer
Date of report:	3/15/2006

Clinical study summary:
This trial was prematurely terminated because too few patients fulfilled the inclusion criteria, owing to an insufficiently large patient pool in this specific setting. Clinical trial results, other than key safety statements, have not been posted, due to insufficient data.

Study center(s) :
5 centers in Switzerland

Objectives:
To determine the proportion of patients with metastatic or locally advanced carcinoma of the bladder who responded to Herceptin monotherapy. Secondary: Evaluation of time to progression, overall survival, and safety after Herceptin treatment.

Methodology:
Patients received an initial dose of 4mg/kg of Herceptin, followed by weekly doses of 2mg/kg , until disease progression.

Number of patients (planned/analyzed):
7

Diagnosis and main criteria for inclusion:
Patients ≥ 18 years of age, with histologically confirmed metastatic or locally advanced bladder cancer, and HER2 overexpression (3+) or HER2 overexpression (2+) and HER2 gene amplification (measured with FISH).

Test product, dose and mode of administration or test procedure:
Loading dose of 4mg/kg Herceptin iv over 90 minutes, followed by weekly infusions of a 2mg/kg maintenance dose iv over 30 minutes.

Duration of treatment:
Until disease progression

Criteria for evaluation (efficacy, safety):
Efficacy: Overall response rate, benefit rate, time to response, overall survival. Safety: Adverse events, laboratory parameters.

Statistical methods:
Because of the premature termination of the study, there was no efficacy evaluation. Safety data were evaluated descriptively.

Summary (efficacy, safety, other results):
Safety: Six patients died of progressive disease; an additional patient died of a suspected pulmonary embolism, which was considered unlikely to be associated with Herceptin treatment. All serious adverse events, other than the suspected pulmonary embolism described above, were considered unrelated to treatment.

Conclusions:
No conclusions can be drawn from this study, due to its early termination.