Linsitinib

Generic Name: Linsitinib

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₂₃N_₅O

CAS Number: 867160-71-2

Unique Ingredient Identifier: 15A52GPT8T

Background: An orally bioavailable small molecule inhibitor of the insulin-like growth factor 1 receptor (IGF-1R) with potential antineoplastic activity. IGF-1R inhibitor OSI-906 selectively inhibits IGF-1R, which may result in the inhibition of tumor cell proliferation and the induction of tumor cell apoptosis.

Indication: Investigated for use/treatment in cancer/tumors (unspecified) and solid tumors.

Clinical Trials

Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

Phase 2

Recruiting

Conditions: Exophthalmos
Eye Diseases
Proptosis
Thyroid Eye Disease
Graves Orbitopathy
Thyroid Associated Ophthalmopathy
Graves Ophthalmopathy
Orbital Diseases
Endocrine System Diseases
Thyroid Diseases

Interventions: Drug: linsitinib

First Posted Date: 2023-11-01

Last Posted Date: 2025-02-25

Lead Sponsor: Sling Therapeutics, Inc.

Target Recruit Count: 75

Registration Number: NCT06112340

Locations: 🇺🇸
Bascom Palmer Eye Institute, Miami, Florida, United States
🇺🇸
West Virginia University Eye Institute, Morgantown, West Virginia, United States

A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

Phase 2

Active, not recruiting

Conditions: Thyroid Eye Disease
Orbital Diseases
Exophthalmos
Thyroid Associated Ophthalmopathy
Graves Orbitopathy
Endocrine System Diseases
Thyroid Diseases
IGF1R
Eye Diseases
Graves Ophthalmopathy

Interventions: Drug: Placebo
Drug: Linsitinib

First Posted Date: 2022-03-11

Last Posted Date: 2025-01-29

Lead Sponsor: Sling Therapeutics, Inc.

Target Recruit Count: 90

Registration Number: NCT05276063

Locations: 🇺🇸
Bascom Palmer Eye Institute, Miami, Florida, United States
🇺🇸
Sarasota Retina Institute, Sarasota, Florida, United States
🇺🇸
Mass Eye and Ear, Boston, Massachusetts, United States

and more 27 locations

Eurosarc Trial of Linsitinib in Advanced Ewing Sarcoma

Phase 2

Completed

Conditions: Relapsed Ewing Sarcoma
Refractory Ewing Sarcoma

Interventions: Drug: Linsitinib

First Posted Date: 2015-09-11

Last Posted Date: 2019-06-03

Lead Sponsor: University of Oxford

Target Recruit Count: 16

Registration Number: NCT02546544

Locations: 🇳🇱
Department of Clinical Oncology, Leiden University Medical Center, Leiden, Postzone K1-P, Netherlands
🇮🇹
Istituti Ortopedici Rizzoli, Bologna, Italy
🇫🇷
Universitè Lyon 1 Claude Bernard, Lyon, France

and more 2 locations

A Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial

Phase 2

Completed

Conditions: Advanced Solid Tumors

Interventions: Drug: linsitinib
Drug: paclitaxel
Drug: erlotinib
Drug: Bortezomib
Drug: Dexamethasone

First Posted Date: 2014-02-07

Last Posted Date: 2024-11-20

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 13

Registration Number: NCT02057380

Locations: 🇺🇸
Site US10004, La Jolla, California, United States
🇺🇸
Site US10006, Tampa, Florida, United States
🇺🇸
Site US10002, Baltimore, Maryland, United States

and more 9 locations

Linsitinib in Treating Patients With Gastrointestinal Stromal Tumors

Phase 2

Completed

Conditions: Chondrosarcoma
Carney Complex
Gastrointestinal Stromal Tumor
Paraganglioma

Interventions: Other: Laboratory Biomarker Analysis
Drug: Linsitinib
Other: Pharmacological Study

First Posted Date: 2012-03-22

Last Posted Date: 2018-09-21

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 20

Registration Number: NCT01560260

Locations: 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸
Stanford Cancer Institute, Palo Alto, California, United States
🇺🇸
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States

and more 5 locations

Linsitinib or Topotecan Hydrochloride in Treating Patients With Relapsed Small Cell Lung Cancer

Phase 2

Completed

Conditions: Recurrent Small Cell Lung Carcinoma

Interventions: Other: Laboratory Biomarker Analysis
Drug: Linsitinib
Other: Pharmacological Study
Drug: Topotecan Hydrochloride

First Posted Date: 2012-02-15

Last Posted Date: 2016-01-14

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 44

Registration Number: NCT01533181

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital, Baltimore, Maryland, United States
🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States

and more 8 locations

Linsitinib in Treating Patients With Asymptomatic or Mildly Symptomatic Metastatic Prostate Cancer

Phase 2

Completed

Conditions: Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Hormone-resistant Prostate Cancer

Interventions: Drug: linsitinib
Other: laboratory biomarker analysis

First Posted Date: 2012-02-15

Last Posted Date: 2015-03-13

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 17

Registration Number: NCT01533246

Locations: 🇺🇸
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
🇺🇸
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

A Study to Look at How a Single Oral Dose of 14C-OSI-906 is Absorbed, Broken Down and Eliminated in the Body

Phase 1

Completed

Conditions: Advanced Solid Tumors
Pharmacokinetics of 14C-OSI-906

Interventions: Drug: radio-labeled OSI-906
Drug: OSI-906

First Posted Date: 2012-02-09

Last Posted Date: 2024-11-07

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 5

Registration Number: NCT01529684

Locations: 🇺🇸
Northwest Medical Specialties, PLLC, Tacoma, Washington, United States
🇺🇸
Comprehensive Clinical Development NW, Inc., Tacoma, Washington, United States

Phase I/II Study of Postoperative Adjuvant Chemoradiation for Advanced-Stage Cutaneous Squamous Cell Carcinoma of the Head and Neck (cSCCHN)

Phase 1

Withdrawn

Conditions: Squamous Cell Carcinoma of the Skin
Recurrent Skin Cancer
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity

Interventions: Drug: erlotinib hydrochloride
Drug: placebo
Drug: linsitinib
Radiation: radiation therapy
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis

First Posted Date: 2011-11-06

Last Posted Date: 2014-11-19

Lead Sponsor: OHSU Knight Cancer Institute

Registration Number: NCT01465815

Locations: 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States

Phase II Study of Cetuximab With or Without OSI-906 in Head and Neck Squamous Cell Carcinoma (HNSCC)

Phase 2

Withdrawn

Conditions: Head and Neck Cancer

Interventions: Drug: Cetuximab
Other: Placebo
Drug: OSI-906

First Posted Date: 2011-09-01

Last Posted Date: 2013-04-05

Lead Sponsor: M.D. Anderson Cancer Center

Registration Number: NCT01427205

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