Melanoma Clinical Trial

Effect of Pexidartinib on the Way the Body Processes CYP3A4 and CYP2C9 Substrates (Pharmacokinetics)

Summary

This study has two parts.

Part 1 will evaluate how pexidartinib affects the way the body processes CYP3A4 and CYP2C9 substrates using midazolam and tolbutamide, respectively, as probe agents.

Part 2 will test the efficacy and safety of pexidartinib treatment in various tumor types.

In Part 2, the same participants will continue to receive pexidartinib twice daily.

Participants will be allowed to continue using pexidartinib as long as the participant derives benefit.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Is the age of majority in country of residence

Has a diagnosis of:

tenosynovial giant cell tumor (TGCT), which is associated with severe morbidity or functional limitations and for whom surgery is not an option (prior pexidartinib is permitted for TGCT patients unless ineffective or not tolerated and there has been a washout period of at least 4 weeks)
KIT-mutant tumor, including melanoma or gastrointestinal stromal tumor (GIST), for which there is no standard systemic therapy, or
other solid tumors (all comers) for which there is no standard systemic therapy and there is a rationale for use of pexidartinib at the Investigator's discretion
If a female of childbearing potential, had a negative serum pregnancy test within 14 days before enrollment, or within 72 hours before enrollment where required

Is a non-sterile male or female willing to use of one of the protocol-defined highly effective contraception methods:

intra-uterine device (nonhormonal or hormonal)
sexual abstinence (only if this is in line with the patient's current lifestyle)
barrier methods (eg, condom, diaphragm) used in combination with hormonal methods associated with inhibition of ovulation
Is a surgically sterile male or female, or is postmenopausal for at least 1 year, at least 50 years of age, with a follicle-stimulating hormone level > 40 milli-International units per mL (mIU/mL)
Has adequate hematologic, hepatic, and renal function as defined by the protocol
Is able and willing to follow all study procedures
Has provided a signed informed consent

Exclusion Criteria:

Is pregnant or breastfeeding
Is unable to swallow oral medication
Is unable to follow study procedures
Is taking or has taken any medications or therapies outside of protocol-defined parameters

Has any disease or condition that, per protocol or in the opinion of the investigator, might affect:

safety and well-being of the participant or offspring
safety of study staff
analysis of results

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

32

Study ID:

NCT03291288

Recruitment Status:

Completed

Sponsor:

Daiichi Sankyo, Inc.

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There are 11 Locations for this study

See Locations Near You

HonorHealth
Scottsdale Arizona, 85258, United States
University of Arizona
Tucson Arizona, 85719, United States
Stanford University
Palo Alto California, 94304, United States
University of Kansas Cancer Center
Westwood Kansas, 66205, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Karmanos Cancer Center
Detroit Michigan, 48201, United States
Northwell Health
Lake Success New York, 10042, United States
Mary Crowley Cancer Research
Dallas Texas, 75230, United States
Leids Universitair Medisch Centrum
Leiden , 2333 , Netherlands
Christchurch Hospital NZ
Christchurch , 8011, New Zealand
National Taiwan University Hospital
Taipei , 10002, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

32

Study ID:

NCT03291288

Recruitment Status:

Completed

Sponsor:


Daiichi Sankyo, Inc.

How clear is this clinincal trial information?

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