A Ph.I/II Dose Escalation Study and Expansion safety/efficacy study.

• Research type

  Research Study

• Full title

  A Phase I/II Dose Escalation Study to Assess the Safety, Tolerability and Efficacy of Amphinex-induced Photochemical Internalisation (PCI) of Gemcitabine followed by Gemcitabine/Cisplatin Chemotherapy in Patients with Locally Advanced Inoperable Cholangiocarcinomas

• IRAS ID

  114795

• Contact name

  Richard Sturgess

• Sponsor organisation

  PCI Biotech

• Eudract number

  2012-002888-10

• Research summary

  This is a Phase I/II study to evaluate the safety, tolerability and efficacy of Amphinex in combination with chemotherapy in patients with locally advanced cholangiocarcinoma. The Phase I study will confirm a safe combination dosing of Amphinex and Gemcitabine and the Phase II will explore this combination in a small randomised study. Amphinex is a photosensitizing compound (which has the potential to enhance the uptake of chemotherapy agents by cancer cells) activated by laser light application that can be targeted with surgical precision to the tumour volume. Timed sequencing of Amphinex followed by Gemcitabine, followed by exposure of the tumour to laser illumination should cause a release of cytotoxic agent from the Amphinex in the cancer cells within the illumination field. PK blood samples will be taken at predefined time-points. Once sufficiently recovered, patients will then go onto receive standard combination chemotherapy with Cisplatin/Gemcitabine which are administered on days 1 and 8 of a repeating 21 day for up to 8 cycles providing there is no evidence of progression and the treatment is well tolerated. Vital signs, physical examination, adverse events evaluation and safety blood tests will be done at these visits. A follow up visit will be performed at a minimum of 30 days after the last chemotherapy dose. Patients who have responded will be followed for relapse and survival for at least 15 months.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  12/NW/0739

• Date of REC Opinion

  6 Dec 2012

• REC opinion

  Further Information Favourable Opinion