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This is an open-label, Phase 1, dose escalation study of oral ARQ 092 administered to subjects with advanced solid tumors and recurrent malignant lymphoma. The study is designed to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARQ 092 and to define a recommended Phase 2 dose of ARQ 092.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARQ 092 | Drug | Subjects in this study will receive ARQ 092 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 10 mg every other day (QOD) and will escalate until the MTD or RP2D is determined. Cycles will be repeated in four-week (28 day) intervals until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment will be permitted. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety and tolerability of ARQ 092 in subjects with advanced solid tumors and recurrent malignant lymphoma by monitoring frequency and severity of adverse events | Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the pharmacokinetic profile (Cmax, AUC, and half-life) of ARQ 092 | During the first 29 days of treatment for each dose level | |
| Assess pharmacodynamic activity | During the first 29 days of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
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| Determine preliminary evidence of activity as defined by RECIST v 1.1 | Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 16 weeks |
| Determine recommended Phase 2 dose | Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 16 weeks |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Miami | Florida | 33136 | United States |
| Atlanta | Georgia | 30322 | United States |
| Atlanta | Georgia | 30341 | United States |
| Lafayette | Indiana | 47905 | United States |
| San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009369 | Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C000608559 | Miransertib |
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