IRB #

STUDY00021819

Title

A Phase 1-2 Study of the Safety, Pharmacokinetics, and Activity of ASTX029 in Subjects With Advanced Solid Tumors

Principal Investigator

Shivaani Kummar

Study Purpose

This is a first-in-human study. The purpose of the study is to learn more about the study drug, ASTX029, in people with advanced cancer. We are hoping to gather information on the safety of the study drug and find the appropriate dose of this experimental drug to use in this and other studies.

Medical Condition(s)

Phase 1b:
- advanced cancer with BRAF (BRAF V600 mutation or activating atypical non-V600 aberrations), KRAS, NRAS, or HRAS.mutation
- who are not candidates for approved or available therapies.

Phase 2:
- NRAS-mutant melanoma.
- KRAS-mutant or KRAS-amplified NSCLC.
- BRAF V600-mutant cancers
- BRAF-fusion cancers.
- Gynecological cancers with alterations in the MAPK pathway
- Other advanced cancer with upregulated MAPK signal pathway

Eligibility Criteria

1. Men or women 18 years of age or older.
2. Adequate organ function
3. Other criteria apply

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

The study is expected to last about 3 years. The amount of time you will participate on the study will depend on how you respond to the study drug. After you stop receiving the study drug, you will be asked to return to clinic for a safety follow-up visit roughly 30 days after your last dose of the study drug. Afterwards, the sponsor may contact you every 3 months continue to collect health information to evaluate the study drug’s long-term effects.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080
trials@ohsu.edu

Sponsor

Astex Pharmaceuticals, Inc.

Recruitment End

12/31/2022

Compensation Provided

No


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