Phase II multicenter,open-label, clinical and pharmacokinetic study of Aplidin® as a 3-hour infusion every 2 weeks, in patients with advanced or metastatic transitional cell carcinoma of the urothelium, relapsing or progressing after first line chemotherapy

Pharma Mar, S.A0 sites0 target enrollmentMarch 31, 2005

Overview

No summary available.

Registry

who.int

Start Date

March 31, 2005

End Date

March 20, 2007

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Pharma Mar, S.A

•1\.Written informed consent obtained from the patient before starting any study\-specific procedure. If any patient is unable to give consent, it may be obtained from the patient’s legal representative if in accordance with local laws and regulations.
•2\.Transitional cell carcinoma of the urothelium of the bladder, urether or renal pelvis, with the following characteristics:
•·Confirmed pathological diagnosis.
•·Advanced (locally advanced or metastatic) and / or non\-resectable disease (surgical exeresis does not eradicate all the macroscopic disease).
•·With documented objective progression according to the RECIST criteria within 6 months prior to registration.
•·Presence of at least one measurable lesion (RECIST). In case of a single measurable lesion, pathological proof of malignancy is mandatory.
•3\.One previous line of systemic chemotherapy. All prior therapies should have been finished at least 3 weeks before patient registration.
•4\.Prior radiotherapy: a minimum of 4 weeks (8 weeks in case of extensive prior radiotherapy) must have elapsed between the end of the prior radiotherapy and entry into the protocol. Previously irradiated lesions may not be used as indicator lesions unless a new lesion has occurred in a previously irradiated area.
•5\.Recovery from any toxicity derived from previous treatments. The presence of alopecia and NCI\-CTC grade \< 2 symptomatic peripheral neuropathy is allowed.
•6\.Age \> 18 years.

•1\.Prior therapy with Aplidin®.
•2\.More than one line of prior systemic chemotherapy.
•3\.Pregnant or lactating women; men and women of reproductive potential who are not using effective contraceptive methods.
•If subject is female, she is eligible to enter and participate in this study if she is of:
•a.non\-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
•b.child\-bearing potential, has a negative pregnancy test (urine or serum) at screen, and agrees to one of the following:
•·Complete abstinence from intercourse from 2 weeks prior to administration of the study drug, throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the investigational drug (a minimum of 5 plasma half\-lifes); or,
•·Female sterilization; or,
•·Sterilization of male partner; or,
•·Implants of levonorgestrel; or,