Clinical Trials Logo
  1. Home
  2. Lung Cancer
  3. NCT00078390
  4. Details
NCT00078390 Clinical Trial

Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:
A Phase I/II Study of the Safety, Pharmacokinetic Interaction and Efficacy of S-3304 in Combination With Standard Therapy in Patients With Locally Advanced Non-small Cell Lung Cancer.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00078390
Other study ID # 0207P1421
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date February 2003
Est. completion date October 26, 2006

Study information
Verified date April 2018
Source Shionogi Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A study to measure the safety and effectiveness of S-3304 when given in combination with conventional chemo-radiation therapy in patients with locally advanced non-small cell lung cancer.

Description:

A two part study to evaluate the safety and efficacy of S-3304 in combination with standard therapy in patients with locally advanced non-small cell lung cancer. The first part of the study is a Phase I design to evaluate the maximum tolerated dose of S-3304 when given in combination with radiation and paclitaxel/carboplatin chemotherapy that is appropriate for further evaluation. The second part of the study is a randomized Phase II design to evaluate the efficacy of recommended S-3304 dose in combination with chemo-radiation.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date October 26, 2006
Est. primary completion date September 28, 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility INCLUSION CRITERIA

- newly diagnosed non-small cell lung cancer of stage IIIA non-resectable or of stage IIIB without pleural effusion

- ECOG performance status 0-1

- adequate organ function

- clinically indicated and able to receive conventional chemoradiation therapy

EXCLUSION CRITERIA

- patients with prior history of cancer, other than basal cell carcinoma after appropriate treatment, or prior systemic chemotherapy treatment

- patients with other serious intercurrent illness including HIV/AIDS, or contraindicated for paclitaxel/carboplatin or thoracic irradiation treatment

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• S-3304
S-3304 will be administered at the tolerable dose BID along with chemo-irradiation
Other:
• Chemo-irradiation
Standard of care chemo-irradiation

Locations
Country Name City State
United States The Cleveland Clinic Cleveland Ohio
United States VA Medical Center-East Orange (study available to veterans only) East Orange New Jersey
United States University of Kansas Cancer Center Kansas City Kansas
United States Scripps Cancer Institute La Jolla California
United States Lombardi Cancer Center Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Shionogi

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Completed NCT03918538 - A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors N/A
Recruiting NCT05078918 - Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors N/A
Active, not recruiting NCT04548830 - Safety of Lung Cryobiopsy in People With Cancer Phase 2
Completed NCT04633850 - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05583916 - Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05898594 - Lung Cancer Screening in High-risk Black Women N/A
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03575793 - A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer Phase 1/Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Terminated NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Terminated NCT03275688 - NanoSpectrometer Biomarker Discovery and Confirmation Study
Not yet recruiting NCT04931420 - Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels Phase 2
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Recruiting NCT06052449 - Assessing Social Determinants of Health to Increase Cancer Screening N/A
Not yet recruiting NCT06017271 - Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
Recruiting NCT05787522 - Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk