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Phase 1-2 Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas

Status
Active
Cancer Type
Cervical Cancer
Lymphoma
Skin Cancer (Non-Melanoma)
Unknown Primary
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT02503423
Protocol IDs
ASTX660-01 (primary)
NCI-2017-01760
Study Sponsor
Astex Pharmaceuticals

Summary

This is an open-label, dose-escalation Phase 1 / 2 study to assess the safety of ASTX660, determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing regimen, and to obtain preliminary efficacy, pharmacokinetic (PK), and target engagement data, in subjects with advanced solid tumors or lymphoma for whom standard life-prolonging measures are not available.

Objectives

ASTX660 is a synthetic small molecule dual antagonist of cellular inhibitor of apoptosis protein (cIAP) 1 and X-linked inhibitor of apoptosis protein (XIAP) that has been shown to have potent proapoptotic and tumor growth inhibitory activity in nonclinical models. ASTX660 has not been previously evaluated in human subjects. The Phase 1 portion of the study will determine the MTD, RP2D, and recommended dosing regimen. The Phase 2 portion will evaluate activity in selected tumor types. Subjects will continue to receive their assigned treatment throughout the study until the occurrence of disease progression, death, or unacceptable treatment-related toxicity, or until the study is closed by the sponsor. Tolerability and safety of study treatment will be evaluated throughout the study by collection of clinical and laboratory data. In Phase 2, antitumor response will be assessed according to standard Response Evaluation Criteria in Solid Tumors (RECIST v1.1) using computed tomography (CT) or magnetic resonance imaging (MRI) scans or assessed using another reliable method of disease evaluation appropriate for the tumor type.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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