Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Can a pill turn on genes that stop cancer? new trial begins

NCT ID NCT03366116

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 24 times

Summary

This early-phase trial tests a new drug called Aza-TdC in adults with advanced solid tumors that have worsened after standard treatment or have no effective therapy. The drug is taken by mouth in 21-day cycles and aims to reactivate genes that may slow tumor growth. The main goals are to check the drug's safety and find the best dose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Aza-TdC (a drug that may turn back on genes that slow tumor growth)
What this could lead to
If it works, this could lead to a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is an early Phase 1 trial with only 65 participants, focused on safety and dosing. It is too soon to know if the drug will effectively shrink tumors or improve survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2018

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 120 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: * Patients must have histologically documented solid tumors whose disease has progressed on standard therapy or for which there is no available standard therapy. * Age \>=18 years of age. * ECOG performance status \<= 2. * Patients must have normal organ and marrow function as defined below: * absolute neutrophil count \>= 1,500/mcL * platelets \>=100,000/mcL * total bilirubin \<=1.5 X institutional upper limit of normal (\<=3 x upper limit of normal in the presence of documented Gilbert s syndrome) * AST(SGOT)/ALT(SGPT) \<=3 X institutional upper limit of normal OR * AST(SGOT)/ALT(SGPT) \<=5 X institutional upper limit of normal for patients with liver metastases * creatinine \<=1.5X institutional upper limit of normal OR * creatinine clearance \>=60 mL/min/1.73 m\^2 for patients with creatinine levels above 1.5X institutional normal * Because nucleoside analogs are known to be teratogenic, women of child-bearing potential and men must agree to use two forms of contraception (hormonal or barrier method of birth control; abstinence; sterilization) prior to study entry, for the duration of study participation, and for 3 months after completing study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use two forms of contraception prior to the study, for the duration of study participation, and for 3 months after completion of administration of Aza-TdC. * Patients must have completed any chemotherapy or biologic therapy \>= 4 weeks or 5 half-lives (whichever is shorter) (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. Patients must be \>= 2 weeks since any prior palliative radiation or cyberknife therapy. Patients must have recovered to grade 1 from prior toxicity or adverse events. Patients on study may be eligible for palliative radiotherapy to non-targeted lesions after 2 cycles of therapy at the PI's discretion. Patients with bone metastases or hypercalcemia on intravenous bisphosphonate treatment prior to study entry may continue this treatment. * Ability to understand and the willingness to sign a written informed consent document. * Willingness to provide blood and urine samples for research purposes. * Ability to swallow pills/capsules. * Left ventricular ejection fraction greater than 45% or the institutional lower limit of normal by either ECHO or MUGA at entry. * For patients enrolled on the expansion cohort, patients must have tumor amenable to biopsy (excisional or incision biopsies of skin or H \& N lesions under visualization) and willingness to undergo tumor biopsies. EXCLUSION CRITERIA: * Patients who are receiving any other investigational agents. * Pregnant women and women who are breastfeeding are excluded from this study. * 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. * Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions: * Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met: * Evaluable or measurable disease outside the CNS * No metastases to brain stem, midbrain, pons, medulla, or cerebellum * No history of intracranial hemorrhage or spinal cord hemorrhage * No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted. * No neurosurgical resection or brain biopsy within 28 days prior to Cycle 1, Day 1 * Patients with treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following: * No stereotactic radiation or whole-brain radiation within 14 days prior to Cycle 1, Day 1 * Screening CNS radiographic study 2 weeks from completion of radiotherapy and \>=1 week from discontinuation of corticosteroids. The presence of new CNS mets will not exclude the patient but provide a baseline. If the irradiated lesion showed increased edema or growth, patient may be enrolled if asymptomatic but a repeat MRI should be done within the next 2-4 weeks for follow up. * Malabsorption syndrome or other conditions that would interfere with intestinal absorption.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Neoplasms are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.