Study of Satraplatin (JM-216) in Combination With Docetaxel

Agennix

Status and phase

Terminated

Phase 1

Conditions

Tumors

Treatments

Drug: satraplatin and docetaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00125411

CO 04904

Details and patient eligibility

About

This is a single center, open-label, non-randomized, Phase I dose finding study of the investigational, oral cytotoxic drug, satraplatin (JM-216), in combination with docetaxel in patients with advanced solid tumors for whom curative therapy is not available. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.

PURPOSE: The purpose of this trial is to determine a tolerable dose and schedule for the combination of satraplatin and docetaxel when given to patients with advanced solid tumors.

WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative chemotherapy measures do not exist or are no longer effective
Life expectancy of at least 3 months
Measurable or evaluable disease
ECOG performance status of <= 2
Willingness and ability to give informed consent

Exclusion criteria

Women who are pregnant or breastfeeding
Other chemotherapy treatment less than 4 weeks prior to enrollment
Treatment with docetaxel or a platinum agent less than 3 months prior to enrollment
Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational