Treatment for Giant Cell Tumor

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Colorado - Denver, Denver, COGiant Cell Tumor+5 More
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug, DCC-3014, in patients with solid tumors or a rare tumor of the tendon called tenosynovial giant cell tumor (TGCT). The trial has two parts: dose escalation (phase 1) and expansion (phase 2). In phase 1, both types of patients will be enrolled. In phase 2, only TGCT patients will be enrolled, in two different cohorts.

Eligible Conditions
  • Giant Cell Tumor of the Tendon Sheath
  • Diffuse Tenosynovial Giant Cell Tumor
  • Pigmented Villonodular Synovitis
  • Giant Cell Tumor of Tendon Sheath
  • Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

9 Primary · 5 Secondary · Reporting Duration: Cycle 1 through study completion (~ 24 months)

Week 25
Objective response rate (ORR= complete response [CR]+partial response [PR]) (Expansion Phase only)
Response rate (Expansion Phase only)
Baseline through 24 months
Duration of response rate (DOR) (Expansion Phase only)
Week 25
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)
Range of Motion (ROM) (Expansion Phase only)
Worst Stiffness Numeric Rating Scale (NRS) Score (Expansion Phase only)
Day 8
Area under the concentration-time curve of DCC-3014
Half life of DCC-3014
Maximum observed concentration of DCC-3014
Time to maximum observed concentration of DCC-3014
Trough observed concentration of DCC-3014
Month 24
Incidence of Adverse Events
Day 28
Maximum tolerated dose

Trial Safety

Safety Progress

1 of 3

Trial Design

0 Treatment Group

120 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · Phase 1 & 2

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: cycle 1 through study completion (~ 24 months)

Who is running the clinical trial?

Deciphera Pharmaceuticals LLCLead Sponsor
14 Previous Clinical Trials
1,811 Total Patients Enrolled
Maitreyi Sharma, MDStudy DirectorDeciphera Pharmaceuticals LLC

Eligibility Criteria

Age 18+ · All Participants · 15 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your organs and bone marrow are working properly.
You have a type of tumor called TGCT that is causing symptoms, and cannot be removed by surgery. A biopsy of the tumor is needed to confirm the diagnosis if there is no prior histology or pathology available.

Frequently Asked Questions

Is enrollment for this research endeavor still being accepted?

"The clinical trial's introduction and latest update can both be found on the website of clinicaltrials.gov. This research was published in February 2017, with an updated version issued December 2021. The project is currently seeking participants to join its ranks." - Anonymous Online Contributor

Unverified Answer

At how many centers is this experiment taking place?

"This medical trial is currently enrolling patients at numerous research centers, such as Stanford Cancer Institute in Palo Alto, California; MSKCC in New York City; and Oregon Health & Science University situated in Portland, Oregon." - Anonymous Online Contributor

Unverified Answer

What is the scope of enrollment for this clinical trial?

"This trial requires 120 volunteers who meet the eligibility criteria. Participatory locations include Stanford Cancer Institute in Palo Alto and MSKCC, located in New York City." - Anonymous Online Contributor

Unverified Answer

What is the fundamental purpose behind this clinical experiment?

"According to Deciphera Pharmaceuticals LLC., the primary measure of efficacy over a 24-month period is Maximum tolerated dose. Additionally, Response rate (Expansion Phase only) assessed by central read using tumor volume score and modified RECIST (mRECIST) Version 1.1, Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score (Expansion Phase only), and Worst Stiffness Numeric Rating Scale (NRS) Score(Expansion Phase only) are being studied as secondary outcomes." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.