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NCT00093132
A Phase 1/2 Study With Satraplatin and Simultaneous Radiation in Locally Advanced Non-Small Cell Lung Cancer
Phase 1/Phase 2 trial testing Satraplatin in Carcinoma, Non-small Cell Lung in 20 participants. Terminated before completion.
1 January 2009
Quick facts
| Lead sponsor | Agennix |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 August 2004 |
| Primary completion | 1 January 2009 |
| Estimated completion | 1 February 2009 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Satraplatin — full drug profile →
Conditions studied
- Carcinoma, Non-small Cell Lung — all drugs for Carcinoma, Non-small Cell Lung →
- Lung Cancer — all drugs for Lung Cancer →
Sponsor
Agennix — full company profile →
Who can join
18 and older, any sex, with Carcinoma, Non-small Cell Lung or Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Determination of MTD and recommended dose for phase II trials
Time frame: 30 days
Sponsor's own description
PURPOSE: This trial is designed to compare the combination of the investigational oral cytotoxic drug, satraplatin, and radiation therapy for patients with locally advanced Non-Small Cell Lung Cancer (NSCLC) with no prior chemotherapy or radiation therapy treatment. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria. 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. RATIONALE: Intravenously administered platinum-based drugs are currently used in combination with radiation therapy in the treatment of patients with locally advanced NSCLC. The purpose of this Phase I trial is to determine a tolerable dose and schedule for the oral platinum drug (satraplatin) when given to NSCLC patients throughout the course of their radiotherapy treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00093132
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Satraplatin
Trials testing the same drug.
- NCT01259479 — Satraplatin in Children and Young Adults With Refractory Solid Tumors Including Brain Tumors · Phase 1 · completed
- NCT00634647 — Satraplatin and Prednisone to Treat Prostate Cancer · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00093132 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Agennix
- Last refreshed: 9 August 2012
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00093132.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing