New cancer drug trial halted early – what we know
NCT ID NCT02711137
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested an experimental drug called INCB057643 in 137 people with advanced cancers that had stopped responding to standard treatments. The goal was to find a safe dose and check for side effects, both when given alone and with other cancer drugs. The trial was terminated early, so results are limited.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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137 people
The number who actually took part.
- Started
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May 2016
- Finished
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Feb 2019
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of relapsed or refractory advanced or metastatic malignancies: * Part 1: solid tumors or lymphomas, or hematologic malignancies * Part 2: histologically confirmed disease in specific tumor types * Part 3: advanced solid tumor or hematologic malignancy * Part 4: select advanced solid tumor or hematologic malignancy * For Part 1 and 2, subjects must have progressed following at least 1 line of prior therapy and there is no further established therapy that is known to provide clinical benefit (including subjects who are intolerant to the established therapy) * For Parts 3 and 4, subjects must have progressed following at least 1 line of prior therapy, and the treatment with the select SOC agent is relevant for the specific disease cohort. * Life expectancy \> 12 weeks, for MF subjects in Parts 3 and 4, life expectancy \> 24 weeks * Eastern Cooperative Oncology Group (ECOG) performance status * Parts 1 and 3: 0 or 1 * Parts 2 and 4: 0, 1, or 2 * Willingness to avoid pregnancy or fathering children Exclusion Criteria: * Inadequate bone marrow function per protocol-specified hemoglobin, platelet count, and absolute neutrophil count * Inadequate organ function per protocol-specified total bilirubin, AST and ALT, creatinine clearance and alkaline phosphatase. * Receipt of anticancer medications or investigational drugs within protocol-specified intervals * Unless approved by the medical monitor, may not have received an allogeneic hematopoietic stem cell transplant within 6 months before treatment, or have active graft-versus-host-disease following allogeneic transplant * Unless approved by the medical monitor, may not have received autologous hematopoietic stem cell transplant within 3 months before treatment * Any unresolved toxicity ≥ Grade 2 (except stable Grade 2 peripheral neuropathy or alopecia) from previous anticancer therapy * Radiotherapy within the 2 weeks before initiation of treatment. Palliative radiation treatment to nonindex or bone lesions performed less than 2 weeks before treatment initiation may be considered with medical monitor approval * Currently active and uncontrolled infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment * Untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed * History or presence of abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful * Type 1 diabetes or uncontrolled Type 2 diabetes * HbA1c of ≥ 8% (all subjects will have HbA1c test at screening) * Any sign of clinically significant bleeding * Coagulation panel within protocol-specified parameters
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hematology - Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, 34952, United States
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Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
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HÔPITAL SAINT-LOUIS, Service Hématologie Adultes
Paris, 75010, France
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Institut Jules Bordet, Clinical Trial Conduct Unit
Brussels, B-1000, Belgium
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MultiCare Institute for Research and Innovation
Tacoma, Washington, 98405, United States
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Oncology Consultants, P.A.
Houston, Texas, 77030, United States
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Sarah Cannon Research Institute at Health One
Denver, Colorado, 80218, United States
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Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
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The Methodist Hospital
Houston, Texas, 77030, United States
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University of Alabama
Birmingham, Alabama, 35294-3300, United States
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University of California
La Jolla, California, 92093, United States
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University of Michigan
Ann Arbor, Michigan, 48109, United States
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University of Minnesota
Minneapolis, Minnesota, 55455, United States
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
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University of Rochester, Wilmot Cancer Center
Rochester, New York, 14642, United States
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Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
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Washington University
St Louis, Missouri, 63110, United States
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Yale University
New Haven, Connecticut, 06510, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Custom-Built immune cells take aim at a notorious cancer mutation
- Can regional data improve bone marrow transplant results for blood cancers?
- Could a frailty score predict which older cancer patients survive intensive care?
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers