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 range

18 Years

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With a Treatment-emergent Adverse Event (TEAE)

Timeframe: up to 30 days

Trial details

NCT IDNCT02431260

SponsorIncyte Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-01-31

Results submitted2019-01-29

View on ClinicalTrials.gov More Solid Tumors and Hematologic Malignancy trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.