Pharmion, GPC begin phase 1 trial of satraplatin with Xeloda in patients with advanced solid tumors

By E. Janene Geiss

Philadelphia, May 16 - Pharmion Corp. and GPC Biotech AG announced Tuesday that a phase 1 study evaluating satraplatin in combination with Xeloda (capecitabine) in patients with advanced solid tumors has opened for accrual.

Xeloda is an oral form of 5-FU, a marketed chemotherapy treatment that is used to treat various cancers, including metastatic breast and colorectal cancers, according to a company news release.

The phase 1 study is an open-label study being conducted at Northwestern University Medical Center in Chicago. The primary objective of this study is to determine the maximum tolerated dose for satraplatin in combination with Xeloda in patients with advanced solid tumors, officials said.

The trial is expected to enroll up to 24 patients.

Satraplatin, an investigational drug, is a member of the platinum family of compounds. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally bioavailable compound and is given as capsules that patients can take at home, officials said.

In December, GPC Biotech completed accrual to the Sparc trial and began the rolling submission of a New Drug Application for satraplatin with the Food and Drug Administration. Also in December, GPC Biotech signed a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corp., under which Pharmion was granted exclusive commercialization rights to satraplatin for Europe and certain other territories.

Satraplatin has been studied in clinical trials involving a range of tumors, and phase 2 trials have been completed in hormone refractory prostate cancer, ovarian cancer and small cell lung cancer. Other trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in various other cancers are underway or planned, officials said.

Pharmion is a Boulder, Colo., biotechnology company focused on acquiring, developing and commercializing products to treat hematology and oncology patients.

GPC is a Martinsreid, Germany, company discovering and developing new anticancer drugs.

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