A4991014 Pharmacokinetic/Pharmacodynamic/safety study of PF-01367338

• Research type

  Research Study

• Full title

  A Parallel Phase I Safety, PK and PD Study of the IV Poly (ADP-Ribose) Polymerase (PARP) Inhibitor PF-01367338 (AG-014,699) in Combination with Several Chemotherapeutic Regimens in Patients with Advanced Solid Tumors

• IRAS ID

  32301

• Contact name

  Elizabeth Ruth Plummer

• Sponsor organisation

  Clovis Oncology

• Eudract number

  2009-013879-22

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  PF-01367338 is a drug that may be able to eradicate solid tumours. It is believed to work by stopping an enzyme (called PARP [Poly ADP-Ribose Polymerase]) in the body from repairing genes. It??s believed that, when combined with other cancer treatment, this study drug may help chemotherapy work better. The best combination of treatment doses is unknown. An earlier Phase I study of intravenous PF-01367338 in humans showed little toxicity when given with chemotherapy to patients with advanced cancer. This trial will raise doses until toxicity is reached. Doses of PF-01367338 will start at the lowest dose, 12mg, and may be tested up to 24mg/day for 3 consecutive days depending on toxicity and will be raised if little to no toxicity is found. If serious toxicity is found, doses can also be reduced and will not be raised again. This drug is investigational and there are rules for raising doses based on experienced toxicity. The most significant study drug-related toxicities were blood related. Also including: hypophosphataemia, changes in liver enzymes, fatigue, infection, nausea, vomiting, anorexia, heartburn, constipation, diarrhoea, headache.There will be 3 treatment groups each receiving different combinations of standard chemotherapy with different initial doses of study drug. The investigators will decide which standard chemotherapy is best for each tumor type. Choices are: A. Carboplatin PF-01367338 B. Carboplatin/Paclitaxel PF-01367338 C. Cisplatin/Pemetrexed PF-01367338Subjects must have an acceptable medical history, physical examination, confirmed advanced solid tumours, be greater than 18 years old, and have a life expectancy of > 12 weeks to participate in this study. Onehundred UK subjects may participate in this study. The data will be reviewed regularly to ensure the treatments are safe. There will also be a clinical panel of experts who review data to ensure safety. This study is funded by Pfizer.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  09/H0907/83

• Date of REC Opinion

  21 Dec 2009

• REC opinion

  Favourable Opinion