A Study of R04929097 in Combination With Gemcitabine in Patients With Advanced Solid Tumours

Official Title

A Phase I Study of R04929097 in Combination With Gemcitabine in Patients With Advanced Solid Tumours

Summary:

This is a phase I study to assess the safety and tolerability of the experimental drug RO4929097 in combination with chemotherapy drug gemcitabine in patients with advanced solid tumours and with an expansion cohort for patients with advanced pancreatic cancer. This study will have two parts. Part A is the dose escalation phase. In this portion of the study, groups of patients with advanced solid tumours will receive increasing doses of RO4929097 on days 1-3, 8-10, 15-17 and 22-24 of a 28 day cycle with standard doses of gemcitabine (on days 1,8 and 15 of a 28 day cycle) until the highest tolerated dose is found. Part B is the dose expansion phase. In this portion of the study, only patients with locally advanced and metastatic pancreatic cancer will further test the highest tolerated dose. While receiving the study treatment, patients will have tests and procedures done once a week (days 1, 8, 15, and 22 of a 28 day cycle). As part of the study, all patients must provide archival tumour samples for biomarker research tests and patients in Part A will provide research blood samples for pharmacokinetics (what the body does to the drug) and antiangiogenic biomarker research tests.

Trial Description

Primary Outcome:

  • Safety Profile
Secondary Outcome:
  • Objective Response Rate
  • Correlative and Pharmacokinetic studies

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society