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Treatment of poorly differentiated thyroid carcinoma resistant to conventional therapy, with reverse transcriptase inhibitors. - ND

Treatment of poorly differentiated thyroid carcinoma resistant to conventional therapy, with reverse transcriptase inhibitors. - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-000215-28-IT
Enrollment
Unknown
Registered
2007-03-09
Start date
Unknown
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients affected by thyroid carcinoma MedDRA version: 9.1 Level: HLT Classification code 10043747 Term: Thyroid neoplasms

Interventions

Trade Name: VIRAMUNE Pharmaceutical Form: Tablet Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-

Sponsors

AZIENDA OSPEDALIERA SENESE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: HISTOLOGICAL DIAGNOSIS OF POORLY DIFFERENTIATED THYROID CARCINOMA PRESENCE OF DISTANT METASTASES DEVOTED OF IODINE UPTAKE NON-SUITABLE FOR SURGICAL THERAPY OR OTHER CONVNETIONAL TREATMENT MODALITIES AGE GREATER THAN 18 YEARS LOSS OF IODINE UPTAKE CHRONIC ACTIVE LIVER DISEASE Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: CHRONIC ACTIVE LIVER DISEASE OTHER MALIGNANCIES DIAGNOSED WITHIN 5 YEARS PREGNANCY AND BREAST FEEDING

Design outcomes

Primary

MeasureTime frame
Secondary Objective: see above;Primary end point(s): To demonstrate the ability of the drug to re-induce thyroglobulin synthesis, expression of the NIS gene and re-induction of iodine uptake.;Main Objective: TO TEST THE EFFICACY OF REVERSE TRANSCRIPTASE INHIBITORS IN INDUCING RE-DIFFERENTIATION OF UNDIFFERENTIATED THYROID CARCINOMA, THROUGHT RE-INDUCTION OF THYROGLOBULIN SECRETION, NIS GENE EXPRESSION AND IODINE UPTAKE. TO DEMONSTRATE THE PRESENCE OF RADIOIODINE UPTAKE AND EFFICACY IN THE TUMOR AFTER TREATMENT WITH THE DRUG, AS DEMONSTRATED BY A REDUCTION IN TUMOR VOLUME AND NUMBER OF LESIONS. TO DEMONSTRATE A SIGNIFICANT INCREASE IN SURVIVAL.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026