Acronym:
PIT
ACTRN/NCT /ethics:
ACTRN12617001190392
Scientific title:
An open label dose-finding, safety and tolerability study of Panitumumab, Irinotecan, Trifluridine/Tipiracil in RAS wild-type patients with metastatic colorectal cancer.
Summary of trial and patient characteristics
| Cancer Type | Bowel and colon | ||
|---|---|---|---|
| Trial Type | Treatment | ||
| Phase | Phase I, Phase II | Tumour Stream | Colorectal |
| Age Range | 18 years and older | Cancer Stage | Metastatic or Widespread |
| Sex | Both | Anticipated Start Date | |
| Molecular Target | Anticipated End Date | ||
| Cancer Type | Bowel and colon |
|---|---|
| Trial Type | Treatment |
| Phase | Phase I, Phase II |
| Age Range | 18 years and older |
| Sex | Both |
| Molecular Target | |
| Tumour Stream | Colorectal |
| Cancer Stage | Metastatic or Widespread |
| Anticipated Start Date | |
| Anticipated End Date |
Trial Summary
This study aims to determine the maximum tolerated dose (MTD) and assess the efficacy of panitumumab, irinotecan and trifluridine/tipiracil when given in combination for participants with RAS/BRAF wild-type (WT) metastatic colorectal cancer (mCRC). Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a confirmed diagnosis of metastatic colorectal cancer that is RAS/BRAF wild type. Study details This study will be conducted in two parts: phase Ib and phase II. The study will commence with a phase Ib dose escalation phase, during which participants will be administered Irinotecan (180mg/m2) and Panitumumab (6mg/Kg) intravenously (IV) on Day 1 of every 14 day cycle, in combination with oral Trifluridine/tipiracil twice a day on Days 1-5 of every 14 day cycle. Dosing of trifluridine/Tipiracil will commence at 25 mg/m2 orally twice a day in the first group. If tolerated, the dose will be elevated for subsequent groups up to a maximum of 35 mg/m2 orally twice a day. Phase II of the study will enrol a separate group of participants who will receive the maximum tolerated dose determined in phase Ib. Treatment in both phases will continue until disease progression, unacceptable toxicity or participant withdrawal. Participants will be regularly assessed throughout the study in order to monitor safety and tumour response. Follow-up visits will occur every 12 weeks after the end of treatment visit until death or study closure. It is hoped that this study will provide evidence for further research into this combination, and improve health outcomes for patients with this disease.
Lay Summary
An open label dose-finding, safety and tolerability study of Panitumumab, Irinotecan, Trifluridine/Tipiracil in RAS wild-type patients with metastatic colorectal cancer.
Sponsor / Cooperative group
The Queen Elizabeth Hospital
Participating Hospitals
| Hospital | Clinical Trial Coordinator | Phone | Principal Investigator | Recruitment Status | |
|---|---|---|---|---|---|
| Royal Adelaide Hospital | Anne Milton | anne.milton@sa.gov.au | 08 7074 2342 | Nimit Singhal | Recruiting |
| The Queen Elizabeth Hospital | Pamela Cooper | pamela.cooper@sa.gov.au | 08 8222 6410 | Professor Tim Price | Recruiting |
| Flinders Medical Centre | Alex Scott-Hoy | alex.scott-hoy@sa.gov.au | 08 8204 4830 | Not Yet Recruiting | |
| Lyell McEwin hospital | Andy Phay | andy.phay@sa.gov.au | 08 8282 0833 | Dr Rohit Joshi | Recruiting |