A Study of Ganetespib in Subjects with ALK positive NSCLC v1

• Research type

  Research Study

• Full title

  A Single Arm, Phase 2 Study of Ganetespib in Subjects with Advanced Non- Small-Cell Lung Cancer with Anaplastic Lymphoma Kinase Gene Rearrangement (ALK-Positive NSCLC)

• IRAS ID

  109051

• Contact name

  Fiona Blackhall

• Sponsor organisation

  Synta Pharmaceuticals Corp

• Eudract number

  2012-000639-16

• Clinicaltrials.gov Identifier

  NCT01562015

• Research summary

  This is a Phase 2 study of subjects with ALK positive, advanced non-small-cell lung cancer who have failed up to 3 prior therapies. The study will take place globally at multiple study centers. Subjects will be enrolled to receive ganetespib one time per week for three weeks followed by a rest week; and will repeat this schedule until the cancer gets worse or the subject is unable to tolerate ganetespib. After the patient has taken the last dose of study they will be followed for up to three years to allow for collection of information on long-term effects and the safety of the study drug. The primary goal of the study is to determine how ganetespib is tolerated and how active it is in ALK positive NSCLC.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  12/YH/0419

• Date of REC Opinion

  17 Oct 2012

• REC opinion

  Further Information Favourable Opinion