GDC-0980 once daily in patients with Refractory Solid Tumor or NHL

• Research type

  Research Study

• Full title

  AN OPEN-LABEL, PHASE I, DOSE-ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF GDC-0980 ADMINISTERED ONCE DAILY IN PATIENTS WITH REFRACTORY SOLID TUMORS OR NON-HODGKIN’S LYMPHOMA

• IRAS ID

  10712

• Sponsor organisation

  Genentech, Inc

• Eudract number

  2008-006374-14

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is an open label, phase 1 research study to determine whether the study drug GDC-0980 is safe when given to patients with advanced or metastatic solid tumours for up to 12 months. This research study will also try to determine the best dose of GDC-0980 and find out if it delays tumour growth or shrinks tumours in patients with solid tumours or non-Hodgkin??s lymphoma (NHL). It is anticipated that approximately 42 to 75 patients will be enrolled in this study at three centers in the United States and the European Union.GDC-0980 is an experimental drug made by Genentech, Inc. (the Sponsor of the study). In animal studies and laboratory experiments, GDC-0980 inhibits two key proteins called PI3K (phosphoinositide 3-kinase) and mTOR (mammalian target of rapamycin) that stimulate cancer cells to grow. This experimental drug has been shown to prevent or slow the growth of many different types of human cancer cells grown in animals, but it has not yet been studied in humans.The study includes a screening period that may last up to 2 weeks. In Cycle 1, the participant will be given a single dose of GDC-0980 and followed for 1 week. The treatment period will include a 7-day single-dose PK evaluation, followed by 21 consecutive days of dosing and then a 7-day off-drug observation period. Assessments for side effects and, sometimes, drug levels, will be done at weekly clinic visits for the first cycle. If their doctor thinks that their body is tolerating GDC-0980 treatment, and that their tumour may be responding or its growth is being controlled, the participant may be given the option to continue for up to 1 year of GDC-0980. Each subsequent cycle will be 28 days in length (28 consecutive days of dosing with no off-drug observation period). The participant will have weekly clinic visits during Cycle 2, then visits will occur every 2 weeks for the next 4 months, and then monthly until the end of the study. Participants will have the option of taking part in a DNA Repository sub study to donate an additional blood sample for future genetic research into GDC-0941, cancer or other related conditions. Participants will also have the option of agreeing to allow the use of their Blooflud and/or Tissue for additional Research.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  09/H0801/2

• Date of REC Opinion

  26 Jan 2009

• REC opinion

  Favourable Opinion