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

Roche

Status and phase: Terminated; Phase 2

Conditions: Urinary Tract Cancer

Treatments: Drug: trastuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02013765

ML17599

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Trastuzumab Monotherapy

Experimental group

Description:

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 and continuing for up to 37 weeks.

Treatment:

Drug: trastuzumab