The current prognosis for patients with metastatic brain cancer from NSCLC is very poor.
The current standard treatment for this disease is radiation therapy to the brain. The goal
of the current study is to test whether the combination of orally administered HYCAMTIN
capsules and whole brain radiation therapy will prolong the survival time of patients with
this potentially serious condition.
Six-month SurvivalNumber of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic)
Time to Response (TTR) (CNS-radiologic)
Time to Progression (TTP) (CNS-radiologic)
Time to Progression (TTP) (All Sites of Disease-radiologic)
Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3
Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3
Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3
Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3
Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3
Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3
Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3
Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3
Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3
Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3
Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3
Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3
Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3
Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3
Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3
Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3
Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3
Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3
Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3
Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3
Number of Participants With Any Adverse Event (AE; Both Serious and Non-serious) or Serious Adverse Event (SAE)
Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range
Lesion Assessment and Measurement
Brain Symptoms
Number of Participants Who Died or Progressed
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
GSK Investigational Site, Quebec G1R 2J6, Canada
GSK Investigational Site, Budapest 1529, Hungary
GSK Investigational Site, Csorna 9300, Hungary
GSK Investigational Site, Gyula 5703, Hungary
GSK Investigational Site, Győr 9024, Hungary
GSK Investigational Site, Miskolc 3529, Hungary
GSK Investigational Site, Mátraháza 3233, Hungary
GSK Investigational Site, Nyíregyháza 4400, Hungary
GSK Investigational Site, Pécs 7623, Hungary
GSK Investigational Site, Szombathely 9700, Hungary
GSK Investigational Site, Székesfehérvár 8000, Hungary
GSK Investigational Site, Törökbálint 2045, Hungary
GSK Investigational Site, Zalaegerszeg-Pozva 8900, Hungary
GSK Investigational Site, Bialystok 15-540, Poland
GSK Investigational Site, Bydgoszcz 85-769, Poland
GSK Investigational Site, Gdansk 80-211, Poland
GSK Investigational Site, Krakow 31-115, Poland
GSK Investigational Site, Olsztyn 10-226, Poland
GSK Investigational Site, Olsztyn 10-357, Poland
GSK Investigational Site, Poznan 60-569, Poland
GSK Investigational Site, Kazan 420111, Russian Federation
GSK Investigational Site, Moscow 105229, Russian Federation
GSK Investigational Site, Moscow 115 478, Russian Federation
GSK Investigational Site, Moscow 128128, Russian Federation
GSK Investigational Site, Moscow 129 128, Russian Federation
GSK Investigational Site, Obninsk 249036, Russian Federation
GSK Investigational Site, Orenburg 460021, Russian Federation
GSK Investigational Site, St-Petersburg 197758, Russian Federation
GSK Investigational Site, St. Petersburg 197022, Russian Federation
GSK Investigational Site, Voronezh 394062, Russian Federation
GSK Investigational Site, Banska Bystrica 975 17, Slovakia
GSK Investigational Site, Bratislava 826 06, Slovakia
GSK Investigational Site, Nitra 949 01, Slovakia
GSK Investigational Site, Birmingham, Alabama 35294, United States
GSK Investigational Site, Glendale, Arizona 85304, United States
GSK Investigational Site, Hot Springs, Arkansas 71913, United States
GSK Investigational Site, Anaheim, California 92801, United States
GSK Investigational Site, Duarte, California 91010-3000, United States
GSK Investigational Site, Pleasant Hill, California 94523, United States
GSK Investigational Site, Aurora, Colorado 80012, United States
GSK Investigational Site, Lakeland, Florida 33805, United States
GSK Investigational Site, Tampa, Florida 33612, United States
GSK Investigational Site, Tampa, Florida 33606, United States
GSK Investigational Site, Chicago, Illinois 60612, United States
GSK Investigational Site, Elk Grove Village, Illinois 60007, United States
GSK Investigational Site, Galesburg, Illinois 61401, United States
GSK Investigational Site, Park Ridge, Illinois 60068, United States
GSK Investigational Site, Rockford, Illinois 61108, United States
GSK Investigational Site, Skokie, Illinois 60077, United States
GSK Investigational Site, Indianapolis, Indiana 46227, United States
GSK Investigational Site, Westwood, Kansas 66205, United States
GSK Investigational Site, Paducah, Kentucky 42003, United States
GSK Investigational Site, Metairie, Louisiana 70006, United States
GSK Investigational Site, Minneapolis, Minnesota 55455, United States
GSK Investigational Site, Jackson, Mississippi 39216, United States
GSK Investigational Site, Columbia, Missouri 65201, United States
GSK Investigational Site, Kansas City, Missouri 64154, United States
GSK Investigational Site, Lincoln, Nebraska 68510, United States
GSK Investigational Site, Las Vegas, Nevada 89106, United States
GSK Investigational Site, Las Vegas, Nevada 89135, United States
GSK Investigational Site, Moncton, New Brunswick E1C 8X3, Canada
GSK Investigational Site, Albuquerque, New Mexico 87109, United States
GSK Investigational Site, Albany, New York 12206, United States
GSK Investigational Site, Bronx, New York 10467, United States
GSK Investigational Site, Buffalo, New York 14215-1199, United States
GSK Investigational Site, Buffalo, New York 14215, United States
GSK Investigational Site, Columbus, Ohio 43235, United States
GSK Investigational Site, Hamilton, Ontario L8V 5C2, Canada
GSK Investigational Site, Kingston, Ontario K7L 5P9, Canada
GSK Investigational Site, London, Ontario N6A 4L6, Canada
GSK Investigational Site, Toronto, Ontario M5G 2M9, Canada
GSK Investigational Site, Eugene, Oregon 97401-8122, United States
GSK Investigational Site, Greenfield Park, Quebec J4V 2H1, Canada
GSK Investigational Site, Montreal, Quebec H2L 4M1, Canada
GSK Investigational Site, Montreal, Quebec H1T 2M4, Canada
GSK Investigational Site, Sherbrooke, Quebec J1H 5N4, Canada
GSK Investigational Site, Charleston, South Carolina 29403, United States
GSK Investigational Site, Bedford, Texas 76022, United States
GSK Investigational Site, Corpus Christi, Texas 78412, United States
GSK Investigational Site, Dallas, Texas 75320-2510, United States
GSK Investigational Site, Duncanville, Texas 75137, United States
GSK Investigational Site, Fort Worth, Texas 76104, United States
GSK Investigational Site, Lubbock, Texas 79415, United States
GSK Investigational Site, Sherman, Texas 75090, United States
GSK Investigational Site, Sugarland, Texas 77479, United States
GSK Investigational Site, Everett, Washington 98201, United States
GSK Investigational Site, Vancouver, Washington 98684, United States
GSK Investigational Site, Madison, Wisconsin 53792, United States