Gemcitabine elaidate+cisplatin in Advanced Solid Tumours/NSCLC III/IV

• Research type

  Research Study

• Full title

  A Phase I Open-Label, Ascending Dose Cohort Study of Gemcitabine Elaidate and Cisplatin in Patients with Advanced Solid Tumors followed by an Expanded Cohort of Patients with Stage IIIb/IV NSCLC

• IRAS ID

  108599

• Contact name

  Rebecca Kresteleit

• Sponsor organisation

  Clovis Oncology, Inc.

• Eudract number

  2012-000832-24

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The combination of chemotherapy drugs cisplatin and gemcitabine is clinically effective in a variety of solid tumours, including bladder, breast, ovarian, biliary tract and advanced non-small cell lung cancer (NSCLC). However, resistance to gemcitabine is thought to occur due to low levels of a specific membrane transporter protein, called hENT1. As gemcitabine elaidate does not require this transport protein for entry into cells, it is proposed that gemcitabine elaidate might be more effective in patients with low levels of hENT1 in their tumour cells. Gemcitabine elaidate has shown similar or better activity than gemcitabine in a number of animal models. Therefore, gemcitabine elaidate is being tested with cisplatin in patients with advanced solid tumours and NSCLC. The trial has two parts and patients will participate in either Part 1 or Part 2. Part 1 will try to find out the maximum tolerated dose, the recommended dose for combination therapy and look at the safety and side effects of increasing doses of gemcitabine elaidate and what the body does to the drug in patients with any type of advanced solid tumour in 21-day treatment cycles. Part 2 will further explore the safety and tolerability of the recommended dose of gemcitabine elaidate in combination with cisplatin in patients with lung cancer. Gemcitabine elaidate and cisplatin are both given through a vein. Overall, subjects will be in the trial for 6-8 weeks (up to two weeks screening, one cycle of 3 weeks and an end of trial visit 3 weeks later), however, if the study doctor thinks it is in the patient’s best interest they could receive additional 3-week treatment cycles with this research drug. This study will include a maximum of 30 patients across the US and UK. A pharmaceutical company is funding this study.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  12/LO/1074

• Date of REC Opinion

  19 Jul 2012

• REC opinion

  Favourable Opinion