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Open-label, dose escalation study to evaluate safety, tolerability pharmacokinetic and pharmacodynamic activity, and efficacy of Adrixetinib (Q702) in subjects with relapsed or refractory active chronic graft-versus-host disease (cGVHD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adrixetinib (Q702) | Experimental | Escalating doses of adrixetinib in 28 day cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adrixetinib | Drug | Administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose-Limiting Toxicities (DLTs) | DLTs assessed for each dose level | Cycle 1 (28 Days) |
| Number of Participants with Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) | AEs and SAEs assessed for each dose level. | Cycle 1 (28 Days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) | Maximum Observed Plasma Concentration (Cmax), area under the curve AUC of Q702 and its primary metabolites | Estimated up to Cycle 1 (28 Days) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Proportion of subjects with CR or PR by Cycle 7 Day 1 using Organ-specific response rate based on 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD | Cycle 7 Day 1 (One Cycle is 28 Days) |
| Duration of Response (DOR) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qurient Clinical Trial Information | Contact | +82-31-8060-1610 | clinicaltrial_info@qurient.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic de Barcelona | Recruiting | Barcelona | Spain | |||
| Hospital General Universitario Gregorio Maranon |
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| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
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DOR defined as the time from best response of PR or CR until documented progression of cGVHD, start of new therapy, or death for any reason |
| First CR or PR until documented PD, start of new therapy or death (Estimated up to 24 months) |
| Failure-Free Survival (FFS) | FFS is defined as the time from study enrollment (first date of Q702 treatment) to addition of another systemic therapy for cGVHD, relapse of underlying malignancy, or death whichever is earlier. | Baseline to, whichever occurs first of, PD, Addition of Systemic Immune Suppressive Therapy, or Death due to Any Cause (Estimated up to 24 months) |
| Recruiting |
| Madrid |
| Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Recruiting | Majadahonda | Spain |
| Hospital Universitario Virgen de la Arrixaca | Recruiting | Murcia | Spain |
| Clinica Universidad de Navarra | Recruiting | Pamplona | Spain |
| Hospital Universitario Marques de Valdecilla | Recruiting | Santander | Spain |
| Hospital Universitario Virgen del Rocio | Recruiting | Seville | Spain |
| Instituto de Investigacion Sanitaria | Recruiting | Valencia | Spain |
| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |