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Anti-metabolites

Aza-TdC for Solid Tumors

Phase 1

Recruiting

Led By James H Doroshow, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status < 2

Patients must have normal organ and marrow function as defined below: absolute neutrophil count greater than or equal to 1,500/mcL, platelets greater than or equal to 100,000/mcL, total bilirubin less than or equal to 1.5 X institutional upper limit of normal (<=3 (SqrRoot) upper limit of normal in the presence of documented Gilbert s syndrome), AST(SGOT)/ALT(SGPT) less than or equal to 3 X institutional upper limit of normal OR AST(SGOT)/ALT(SGPT) less than or equal to 5 X institutional upper limit of normal for patients with liver metastases, creatinine less than or equal to 1.5X institutional upper limit of normal OR creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for patients with creatinine levels above 1.5X institutional normal

Must not have

Patients on anti-seizure medications

Patients with clinically significant illnesses which would compromise participation in the study, including, but not limited to active or uncontrolled infection, immune deficiencies, known HIV infection requiring protease inhibitor therapy, known Hepatitis B, known Hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-treatment, cycle 1 day 2, cycle 2 day 10

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, Aza-TdC, to see if it can turn genes back on and slow the growth of tumors in people with cancer.

Who is the study for?

Adults over 18 with advanced solid tumors that have worsened after standard treatment or for which no effective therapy exists. They must be in relatively good health, able to swallow pills, and willing to use two forms of contraception. Excluded are pregnant or breastfeeding women, those with significant illnesses like uncontrolled infections or heart problems, known HIV requiring specific therapy, Hepatitis B/C, brain metastases unless stable and not on anti-seizure meds.

What is being tested?

The trial is testing the safety and appropriate dosage of a new drug called Aza-TdC taken orally by patients with advanced solid tumors. The drug is given in cycles: daily for five days followed by two days off in weeks one and two; no drug in week three. Treatment continues if tolerated well and cancer doesn't progress.

What are the potential side effects?

Specific side effects aren't listed but generally could include typical reactions from anticancer drugs such as nausea, fatigue, blood count changes leading to increased infection risk or bleeding tendencies, liver function alterations affecting metabolism of other drugs/chemicals in the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can do most of my daily activities without help.

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My blood, liver, and kidney functions are within normal ranges.

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My cancer has worsened despite treatment or lacks a standard treatment.

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I agree to use two forms of birth control during and for 3 months after the study.

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I finished my last cancer treatment at least 4 weeks ago, or 6 weeks for specific drugs.

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My heart pumps well, with an ejection fraction over 45%.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking medication for seizures.

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I do not have any major health issues that would stop me from participating in the study.

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I do not have conditions affecting my body's ability to absorb nutrients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-treatment, cycle 1 day 2, cycle 2 day 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-treatment, cycle 1 day 2, cycle 2 day 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-treatment, cycle 1 day 2, cycle 2 day 10 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine the safety, tolerability, and MTD of oral aza-TdCyd administered daily for 5 days a week for 2 weeks, with one week off, in 21-day cycles

Secondary study objectives

To determine effect of study treatment on re-expression of select genes silenced by methylation in circulating tumor cells

To determine the effects of Aza-TdC on DNA damage response (DDR) signaling and on genome-wide DNA methylation in tumor biopsy tissue

To determine the pharmacokinetics of oral aza-TdCyd

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