Study of DCC-3014 in Patients With Advanced Tumours and Tenosynovial Giant Cell Tumour

Official Title

A Multicentre Phase 1/2, Open-Label Study of DCC-3014 to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics in Patients With Advanced Tumours and Tenosynovial Giant Cell Tumour


This is a multicentre, open-label Phase 1/2 study of DCC-3014 in patients with malignant solid tumours and tenosynovial giant cell tumour (TGCT). There will be 2 distinct parts in this study: Dose Escalation (Phase 1) and Expansion (Phase 2). Phase 1 will enroll both malignant solid tumour and TGCT patients. Phase 2 will comprise two cohorts (Cohort A and Cohort B) and will only enroll TGCT patients.

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]) (Expansion Phase only)
  • Duration of response rate (DOR) (Expansion Phase only)
Secondary Outcome:
  • Response rate (Expansion Phase only)
  • Range of Motion (ROM) (Expansion Phase only)
  • Brief Pain Inventory (BPI) Worst Pain Numeric Rating Scale (NRS) Score (Expansion Phase only)
  • Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score (Expansion Phase only)
  • Worst Stiffness Numeric Rating Scale (NRS) Score (Expansion Phase only)

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society