Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Subjects will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group of patients may be enrolled and receive study drug. The initial cohort will be treated with 10 mg QD. The second cohort will be treated with 20 mg QD. The third cohort will be treated with 50 mg QD. Subsequent cohorts will be treated with two times the dose of the prior cohort to a limited toxicity level.

10 mg and 50 mg capsules will be provided and dosed per the dosing schedule.

INCB028060

Lance Leopold

This is an open label, dose escalation study using a 3 + 3 design to determine if INCB028060 (study drug) is safe, well-tolerated and effective in patients with advanced malignancies. Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group is enrolled and may begin to receive study drug. Doses will be escalated unless a dose-limiting toxicity (DLT) is observed in one of three subjects.

A Dose-escalation Study in Subjects With Advanced Malignancies

A Phase 1, Open-label, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of INCB028060 in Subjects With Advanced Malignancies

Samples will be collected at 0 (predose) and 2, 4, and 6 hours after dosing on Day 1 and Day 15 of Cycle 1 for subjects undergoing full PK analysis.

Novartis Pharmaceuticals

Incyte Corporation

Blood and Lymph Conditions

Hematologic Neoplasms

Hematologic Diseases

INCB024360: 25 mg and 100 mg tablets Doses will be escalated in accordance with the dosing schedule.

INCB024360

Lance Leopold, MD

This is an open label, dose escalation study using a 3 + 3 design to determine if INCB024360 (study drug) is safe, well-tolerated and effective in patients with advanced malignancies. Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group is enrolled and may begin to receive study drug. For subject safety, the first subject in each cohort will be administered drug for one week before the next two subjects in the cohort can begin drug administration. Doses will be escalated unless a dose-limiting toxicity (DLT) is observed in one of three subjects.

An expanded cohort of up to 15 patients may be recruited to further explore safety at the 'maximum tolerated dose' or at a lower, pharmacologically active, dose.

A Phase I, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of INCB024360 in Patients With Advanced Malignancies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Dose-escalation Study in Subjects With Advanced Malignancies	NCT01072266	Solid Tumor Advanced Cancer Metastatic Canc...	INCB028060	18 Years -	Incyte Corporation
A Dose-escalation Study in Subjects With Advanced Malignancies	NCT01195311	Solid Tumors an...	INCB024360	18 Years -	Incyte Corporation
A Dose-escalation Study in Subjects With Advanced Malignancies	NCT01072266	Solid Tumor Advanced Cancer Metastatic Canc...	INCB028060	18 Years -	Incyte Corporation

Spots Global Cancer Trial Database for refractory, advanced malignancies