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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

An Open-Label Study of the Safety, Tolerability, and Pharmacokinetic / Pharmacodynamic Profile of VX-803 / M4344 as a Single Agent and in Combination With Cytotoxic Chemotherapy in Participants With Advanced Solid Tumors

The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of single-agent M4344 administered twice-weekly (BIW), twice daily (BID) or once daily dose schedule in participants with advanced solid tumors. This investigation is a three part study examining M4344 alone and in combination with carboplatin, gemcitabine, and cisplatin to determine the safety and maximum tolerated dose.
Not Available
Phase I
Adults
Not Available
Not Available
Not Available
National
Vanderbilt University
09-03-2015
Treatment
VICCPHI14126
NCT02278250

Eligibility

18 Years
BOTH
NO
Inclusion Criteria:

Part A and A2: Participants with one histologically or cytologically confirmed malignant advanced solid tumor, for which no standard therapy is available which may convey clinical benefit

Part B: Participants with one histologically or cytologically confirmed malignant advanced solid tumor, for which no standard therapy is available which may convey clinical benefit and/or participants must have progressed after at least 1 prior chemotherapy regimen in the metastatic setting, and for which carboplatin (for Part B1), gemcitabine (for Part B2), or cisplatin (for Part B3) would be considered standard of care.

Part C: Participants with advanced (locally advanced incurable or metastatic) histologically or cytologically confirmed high-grade serous ovarian cancer (high nuclear Grades 2 or 3). Participants should have either platinum-refractory (disease progression during initial platinum therapy) or platinum-resistant (disease progression
Measurable disease according to RECIST criteria (Version 1.1)

WHO performance status of 0 or 1

Life expectancy of >=12 weeks

Hematological and biochemical indices within acceptable ranges at Screening.



Exclusion Criteria:

Radiotherapy, unless brief course for palliative therapy, endocrine therapy, target-specific therapy, immunotherapy, or chemotherapy during the 4 weeks (6 weeks for nitrosoureas and Mitomycin-C, and 4 weeks for investigational medicinal products) or 4 drug half-lives before first dose of study drug, whichever is greater

Part B: More than 6 cycles of prior therapy with carboplatin

Parts B1, B3, and C: During prior platinum therapy, requirement for dose reduction or discontinuation of carboplatin or cisplatin for toxicity or lack of tolerability

Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 1 toxicities, which in the opinion of the investigator should not exclude the participant a. Any known history of Grade 4 thrombocytopenia with any prior chemotherapy regimen

Spinal cord compression or brain metastases unless asymptomatic, treated, stable, and not requiring steroids for at least 4 weeks before first dose of study drug

Female participants who are already pregnant or lactating, or plan to become pregnant within 6 months of the last dose of study drug are excluded. Female participants of childbearing potential must adhere to contraception guidelines. Female participants will be considered to be of nonchildbearing potential if they have undergone surgical hysterectomy or bilateral oophorectomy or have been amenorrheic for over 2 years with a screening serum follicle-stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females.

Male participants with partners of childbearing potential must agree to adhere to contraception guidelines. Men with pregnant or lactating partners or partners who plan to become pregnant during the study or within 6 months of the last dose of study drug are excluded.

Major surgery =
Serious co-morbid medical conditions, including clinically-significant cardiac disease

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