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Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy

Status
Completed
Cancer Type
Unknown Primary
Trial Phase
Phase II
Eligibility
12 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03640481
Protocol IDs
KD025-213 (primary)
NCI-2018-02858
Study Sponsor
Kadmon, a Sanofi Company

Summary

This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of KD025
in subjects with Chronic Graft Versus Host Disease (cGVHD) after at least 2 prior lines of
systemic therapy

Objectives

Phase 2, open label, randomized, multicenter study in subjects with cGVHD who have previously
been treated with at least 2 prior lines of systemic therapy. Approximately 166 subjects with
active cGVHD will be randomized (1:1) to receive treatment with one of two belumosudil
(formerly known as KD025) regimens:

- Arm A: belumosudil 200 mg QD

- Arm B: belumosudil 200 mg BID

With Amendment 2, the sample size was increased from approximately 126 subjects, with
additional subjects to be enrolled as follows:

- 20 adolescents

- 20 adults into a site-specific Companion Study to collect biospecimens

These additional subjects will also be randomized (1:1) to Arm A or Arm B.

Any adolescent taking a proton pump inhibitor (PPI) or a strong CYP3A4 inducer will begin
Cycle 1 Day 1 at the escalated dose of belumosudil 200 mg BID.

Randomization will be stratified according to prior cGVHD treatment with ibrutinib (Yes / No)
and severe cGVHD at baseline (Yes / No). Subjects may receive treatment in 28-day treatment
cycles until clinically significant progression of cGVHD. Subjects who have not achieved a
response after 12 cycles of belumosudil should be withdrawn if in the Investigator's judgment
there is no evidence of clinical benefit. Subjects will undergo evaluations as outlined in
the Study Assessments table (Appendix A). The primary endpoint is the overall response rate
(ORR) with responses as defined by the 2014 National Institute of Health (NIH) Consensus
Development Project on clinical trials in cGVHD.

Eligibility

  1. Male and female subjects at least 12 years of age who have had allogenic hematopoietic cell transplant (HCT).
  2. Previously received at least 2 and not more than 5 lines of systemic therapy for cGVHD
  3. Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening
  4. Have persistent cGVHD manifestations and systemic therapy is indicated
  5. Karnofsky Performance Score of = 60 (if aged 16 years or older); Lansky Performance Score of = 60 (if aged < 16 years)
  6. Weight = 40kg

Treatment Sites in Georgia

Georgia Cancer Center at Augusta University


1411 Laney Walker Boulevard
Augusta, GA 30912
www.augusta.edu/cancer/

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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