An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies (NCT02431260) | Clinical Trial Compass
TerminatedPhase 1/2
An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies
Stopped: As of 31 JAN 2018, the study was terminated by the sponsor due to PK variability.
United States69 participantsStarted 2015-04-14
Plain-language summary
This was a study of INCB054329 given to patients with advanced malignancies that were conducted in three treatment groups. Each treatment group had a dose escalation (Part 1) and a dose expansion (Part 3), two of the treatment groups also had an intra-patient dose titration (Part 2).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Confirmed diagnosis of advanced malignancy:
* Treatment Group A (TGA): Part 1 and Part 2: Any advanced solid tumor or lymphoma; Part 3: Histologically confirmed disease in specific solid tumors and lymphomas
* Treatment Group B (TGB): Acute Leukemia (Part 3 - acute myeloid leukemia \[AML\] only), myelodysplastic syndrome (MDS), myelodysplastic /myeloproliferative neoplasms (MDS/MPN) and myelofibrosis (MF)
* Treatment Group C (TGC): Multiple myeloma
* Progressed following at least 1 line of prior therapy and there is no further approved therapy available that has been demonstrated to prolong survival (including subjects who are intolerant to the approved therapy)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 in Parts 1 and 2 dose escalation and titration, and 0, 1, 2 in Part 3 dose expansion
Key Exclusion Criteria:
* Inadequate hematopoietic, liver, endocrine or renal function
* Receipt of anticancer medications or investigational drugs within the following interval before the first administration of study drug:
* \< 6 weeks for mitomycin-C or nitrosoureas
* \< 5 half-lives or 14 days, whichever is longer, for any investigational agent (for any indication)
* \< 28 days for any antibodies or biological therapies
* \< 5 half-lives for all other anticancer medications, or sponsor approval
* Prior radiotherapy within 2 weeks prior to first dose of study drug
* Untreated brain or central nervous system (CNS) me…
What they're measuring
1
Number of Participants With a Treatment-emergent Adverse Event (TEAE)