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

Summary:

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)

• 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)

View this trial on ClinicalTrials.gov