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

Phase I Study of the Oral Platinum Agent Satraplatin (JM-216) in Combination With Docetaxel in Treatment of Advanced Malignancies

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00125411

Enrollment

Registered

2005-08-01

Start date

2007-03-31

Completion date

2009-02-28

Last updated

2012-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumors

Keywords

satraplatin, docetaxel, cancer, Phase I, advanced solid tumors

Brief summary

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.

Interventions

DRUGsatraplatin and docetaxel

Satraplatin - oral administration within 2 hours of docetaxel infusion. Subsequent dosing will be on days 2-5 at approximate 24 hour intervals. Docetaxel will be administered as intravenous infusion over 1 hour followed by saline flush.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Maximum Tolerated Dose and Safety	3 weeks

Secondary

Measure	Time frame
Objective response rate	3 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026