Solid tumors MedDRA version: 16.1 Level: PT Classification code 10001388 Term: Adrenocortical carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.1 Level: LLT Classification code 10065147 Term: Malignant solid tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ
Conditions
Interventions
Product Name: Linsitinib 25 mg
Product Code: OSI-906
Pharmaceutical Form: Tablet
Product Name: Linsitinib 100 mg
Product Code: OSI-906
Pharmaceutical Form: Tablet
Product Name: Linsitinib 150 mg
Pro
Sponsors
Astellas Pharma Global Development, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable). 2. Subject must currently be participating in an Astellas sponsored linsitinib trial that has ended with respect to the overall study analysis. 3. Subject must not have met criteria for discontinuation or have progressed on the current linsitinib study in which they are participating. 4. Subject must be deriving benefit from continued treatment as determined by the investigator. 5. Female subject must be either: a. Of non-child bearing potential i. post-menopausal (defined as at least 1 year without any menses) prior to Screening, or ii. documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening). b. or, if of childbearing potential i. must have a negative urine pregnancy test at study entry, and ii. must use two forms of birth control* (at least one of which must be a barrier method) starting at study entry and throughout the study period and for 30 days after final study drug administration. 6. Female subject must not be breastfeeding at study entry or during the study period and for 30 days after final study drug administration. 7. Female subject must not donate ova starting at study entry and throughout the study period and for 30 days after final study drug administration. 8. Male subject and their female spouse/partner(s) who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control* (one of which must be a barrier method) starting at study entry and continue throughout the study period and for 30 days after final study drug administration. 9. Male subject must not donate sperm starting at Screening and throughout the study period, and for at least 30 days after final study drug administration. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: No exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to provide treatment continuation for subjects participating in other Astellas-sponsored studies with linsitinib.;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint of the study is the number of subjects with adverse events.;Timepoint(s) of evaluation of this end point: End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Australia, Brazil, Canada, Czech Republic, Korea, Republic of, Poland, Russian Federation, Singapore, Thailand, United States
Contacts
Public ContactAstellas Pharma Service Desk
Astellas Pharma Europe B.V.
Outcome results
None listed