Neoplasms

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Adrenocortical Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Adrenal Cortex Neoplasms

Adrenal Gland Neoplasms

Endocrine Gland Neoplasms

Adrenal Cortex Diseases

Adrenal Gland Diseases

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Insulin

Insulin, Globin Zinc

Mitogens

OSI-906

Placebo

Medical Director

A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent OSI-906 in patients with locally advanced/metastatic Adrenocortical Carcinoma (ACC) who received at least 1 but no more than 2 prior drug regimens

Patients will be randomized 2:1 to receive either single agent OSI-906 (Arm A) or placebo (Arm B) and will be stratified according to prior systemic cytotoxic chemotherapy for ACC, and Eastern Cooperative Oncology Group (ECOG) performance status, and use of \>= 1 oral antihyperglycemic therapy at randomization

A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma

Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

Time from date of randomization until time of documented death

Time from randomization to disease progression based on RECIST version 1.1 or death due to any cause, whichever comes first

Proportion of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD), based on RECIST criteria

Proportion of patients with a best overall response of CR or PR based on RECIST criteria

Time from date of the first documented response (CP/PR) to documented progression or death due to underlying cancer

Measured by European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma	NCT00924989	Adrenocortical ...	OSI-906 Placebo	18 Years -	Astellas Pharma Inc
A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma	NCT00924989	Adrenocortical ...	OSI-906 Placebo	18 Years -	Astellas Pharma Inc

Spots Global Cancer Trial Database for galacctic

Every month we try and update this database with for galacctic cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for galacctic

Every month we try and update this database with for galacctic cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for galacctic cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.