Study of DCC-3014 in Patients With Advanced Tumours

Official Title

Multi-centre, Phase 1, Open-Label Study of DCC-3014 to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Patients With Advanced Tumours

Summary:

This is a multicentre, open-label Phase 1 study of DCC-3014 in patients with advanced solid tumours including but not limited to prostate, breast, gastric, ovarian, and non-small cell lung cancer as well as tumour types with high macrophage content or high expression of CSF-1 such as diffuse-type tenosynovial giant cell tumour. There will be an Escalation Phase and an Expansion Phase in this study

Trial Description

Primary Outcome:

  • Maximum tolerated dose
  • Incidence of Adverse Events
  • Time to maximum observed concentration of DCC-3014
  • Maximum observed concentration of DCC-3014
  • Trough observed concentration of DCC-3014
  • Area under the concentration-time curve of DCC-3014
  • Half life of DCC-3014
  • Objective response rate (ORR= complete response [CR]+partial response [PR]) (Diffuse type Tenosynovial Giant Cell Tumour [DTGCT] patients Expansion phase only)
  • Duration of response rate (DOR) (DTGCT patients Expansion phase only) Measure time from PR or CR to disease progression or death)
Secondary Outcome:
  • Response rate
  • Range of Motion (ROM)
  • Patient reported outcomes

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