Neoplasms

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Thyroid Neoplasms

Thyroid Diseases

Carcinoma, Neuroendocrine

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Adenocarcinoma

Neoplasms, Nerve Tissue

Thyroid Cancer, Medullary

Neuroendocrine Tumor

Neuroepithelioma

300 mg oral dose once daily (100 mg x 3 tablets)

Vandetanib 300mg

Clinical Sciences & Operations, MD

Open-label Study to Evaluate the Safety and Tolerability of Vandetanib 300 mg/day in Japanese Patients with Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma.

A Phase I/II, Open-label Study to Evaluate the Safety and Tolerability of Vandetanib 300 mg/day in Japanese Patients with Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma

Evaluate the Safety and Tolerability of Vandetanib in Japanese Patients With Medullary Thyroid Carcinoma

A Phase I/II, Open-label Study to Evaluate the Safety and Tolerability of Vandetanib 300 mg/Day in Japanese Patients With Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma

ORR is defined as the percentage of patients who have a confirmed CR (Disappearance of all target lesions) or PR (\>=30% decrease in the sum of diameters of target lesions) prior to any evidence of progression as defined by RECIST V1.1. This percentage is calculated with only patients who had at least measurable lesion in the efficacy analysis set.

Genzyme, a Sanofi Company

Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily

Vandetanib 300 mg

Age, Continuous

>=20 - <50 years

>=50 - <65 years

>=65 years

Age, Customized

Sex: Female, Male

Asian

Race/Ethnicity, Customized

Trial Transparency Team

All patients with post-baseline efficacy assessments

Objective Response Rate Within the First 56 Weeks After the First Dose of Vandetanib

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluate the Safety and Tolerability of Vandetanib in Japanese Patients With Medullary Thyroid Carcinoma	NCT01661179	Unresectable Lo...	Vandetanib 300m...	20 Years -	Sanofi
Evaluate the Safety and Tolerability of Vandetanib in Japanese Patients With Medullary Thyroid Carcinoma	NCT01661179	Unresectable Lo...	Vandetanib 300m...	20 Years -	Sanofi

Spots Global Cancer Trial Database for unresectable locally advanced or metastatic, medullary thyroid carcinoma