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Anti-metabolites

Aza-TdC for Solid Tumors

Q: Are there any slots available to join this experiment?

Affirmative. On clinicaltrials.gov, the details of this medical endeavour are available for inspection and it is currently recruiting applicants. This research was initially posted on November 5th 2018 and last amended on November 18th 2022, with 50 participants being sought from 1 clinic.

Q: To whom is this experiment accessible?

This clinical trial is open to 50 people suffering from <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a> aged 18-120. To be considered, patients must demonstrate a histologically documented solid tumors that has not responded well to traditional treatments or for which there are no available therapies, an ECOG performance status of less than 2, and an age greater than 18 years old.

Q: What is the population size of participants involved in this research endeavor?

Affirmative. According to clinicaltrials.gov, this research initiative initiated on November 5th 2018 is currently recruiting participants from a single location with the aim of enrolling 50 individuals in total.

Q: Has the Food and Drug Administration accepted aza-TdC as safe for general use?

Aza-TdC possesses a low safety rating of 1 due to the limited data backing its efficacy and lack of clinical evidence regarding its potential risks.

Q: Is the eligibility criteria of this clinical trial restricted to individuals aged 30 and below?

Compatible with the study's terms, individuals aged 18 and up to 120 are eligible for enrolment.

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1Experimental Treatment1 Intervention

Aza-TdCyd will be administered orally once a day for 5 days of each week for 2 weeks, with one week off, in 21-day cycles

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,663 Previous Clinical Trials

40,925,855 Total Patients Enrolled

3 Trials studying Tumors

1,244 Patients Enrolled for Tumors

James H Doroshow, M.D.Principal InvestigatorNational Cancer Institute (NCI)

4 Previous Clinical Trials

5,181 Total Patients Enrolled

Media Library

Aza-TdC (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03366116 — Phase 1

Tumors Clinical Trial 2023: Aza-TdC Highlights & Side Effects. Trial Name: NCT03366116 — Phase 1

Aza-TdC (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03366116 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any slots available to join this experiment?

"Affirmative. On clinicaltrials.gov, the details of this medical endeavour are available for inspection and it is currently recruiting applicants. This research was initially posted on November 5th 2018 and last amended on November 18th 2022, with 50 participants being sought from 1 clinic."

Answered by AI

To whom is this experiment accessible?

"This clinical trial is open to 50 people suffering from cancer aged 18-120. To be considered, patients must demonstrate a histologically documented solid tumors that has not responded well to traditional treatments or for which there are no available therapies, an ECOG performance status of less than 2, and an age greater than 18 years old."

Answered by AI

What is the population size of participants involved in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this research initiative initiated on November 5th 2018 is currently recruiting participants from a single location with the aim of enrolling 50 individuals in total."

Answered by AI

Has the Food and Drug Administration accepted aza-TdC as safe for general use?

"Aza-TdC possesses a low safety rating of 1 due to the limited data backing its efficacy and lack of clinical evidence regarding its potential risks."

Answered by AI