PM1183-B-001-10 (v 2.0 dated 04/February/2011)

• Research type

  Research Study

• Full title

  A Phase II Study of PM01183 as Second-line Treatment in Patients with Metastatic Pancreatic Cancer.

• IRAS ID

  75771

• Contact name

  David Cunningham

• Sponsor organisation

  Pharma Mar S.A. Sociedad Unipersonal

• Eudract number

  2010-024292-30

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The study design will be a multicenter, exploratory, two-stage phase II study of single ??agent PM01183- based chemotherapy administered as second line therapy to patients with metastatic pancreatic cancer.The study drug will be administered as an intravenous 1-hour infusion of 7.0 mg flat dose every three weeks.The primary endpoint is to evaluate the antitumor activity of PM01183 in terms of overall survival rate at 6 months (OS6), defined as the percentage of patients who are alive 6 months after the first treatment dose, and other secondary endpoints will be evaluate as progression free survival, response rate and duration of response (by means of the image techniques), tumour marker evolution, safety evaluation and pharmacokinetic analysis.Also, there is a pharmacogenomic substudy for those patients that voluntarily sign a specific inform consent form. The main objective of this substudy is the identification of potential biomarkers of sensitivity or resistance to PM01183.Patients will receive study medication as long as it is considered to be in their best interest (their disease remains under control and side effects are considered acceptable).During the first stage of this study, 21 evaluable patients will be included. If more than 5 patients are alive at 6 months or at least 2 patients respond, recruitment will continue to a maximum of 43 evaluable patients.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  11/NE/0207

• Date of REC Opinion

  5 Sep 2011

• REC opinion

  Further Information Favourable Opinion