Clinical Trials Logo
  1. Home
  2. Advanced Solid Tumors
  3. NCT02057380
  4. Details
NCT02057380 Clinical Trial

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

Advanced Solid Tumors Clinical Trial

Official title:
A Phase II Open-label Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02057380
Other study ID # 7487-CL-0209
Secondary ID 2013-004076-34
Status Completed
Phase Phase 2
First received
Last updated
Start date April 16, 2014
Est. completion date December 21, 2016

Study information
Verified date August 2018
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to provide access to continued treatment for subjects who participated in other Astellas sponsored trials and for whom the investigator feels the subject may benefit from continued treatment.

Recruitment information / eligibility
Status Completed
Enrollment 13
Est. completion date December 21, 2016
Est. primary completion date October 14, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subject must currently be participating in an Astellas sponsored linsitinib trial that has ended with respect to the overall study analysis.

- Subject must not have met criteria for discontinuation or have progressed on the current linsitinib study in which they are participating.

- Subject must be deriving benefit from continued treatment.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• linsitinib
oral
• erlotinib
oral
• paclitaxel
Intravenous (IV) infusion
• Bortezomib
Subcutaneous or IV
• Dexamethasone
IV, Oral

Locations
Country Name City State
Brazil Site BR55005 Porto Alegre Rio Grande Do Sul
Czechia Site CZ42001 Ostrava-Poruba
Germany Site DE49002 Berlin
Germany Site DE49001 Wuerzburg
Poland Site PL48001 Szczecin Zachodniopomorskie
Singapore Site SG65002 Singapore
Thailand Site TH66003 Khon Kaen
United States Site US10008 Ann Arbor Michigan
United States Site US10002 Baltimore Maryland
United States Site US10004 La Jolla California
United States Site US10001 Oklahoma City Oklahoma
United States Site US10006 Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Global Development, Inc.

Countries where clinical trial is conducted

United States,  Brazil,  Czechia,  Germany,  Poland,  Singapore,  Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of subjects with adverse events 24 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04972981 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 in Participants With Selected Advanced Solid Tumors Phase 1
Completed NCT05086822 - A Study of Irinotecan Hydrochloride Liposome in Advanced Solid Tumors Phase 1
Completed NCT03260322 - A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Phase 1
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Recruiting NCT06040541 - Study of RMC-9805 in Participants With KRASG12D-Mutant Solid Tumors Phase 1
Recruiting NCT05862831 - Clinical Study of PM1003 in Phase I/IIa Treatment of Advanced Malignant Solid Tumors Phase 1/Phase 2
Recruiting NCT03641794 - Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Healthy Volunteers Phase 1
Terminated NCT03665129 - IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors Phase 1
Not yet recruiting NCT06413680 - A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies Phase 1/Phase 2
Recruiting NCT05914116 - A Study of DB-1311 in Advanced/Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT01693562 - A Phase 1/2 Study to Evaluate MEDI4736 Phase 1/Phase 2
Recruiting NCT04387916 - A Study of KC1036 in Patients With Advanced Solid Tumors Phase 1
Completed NCT04095273 - Study to Test How Well Patients With Advanced Solid Tumors Respond to Treatment With the Elimusertib in Combination With Pembrolizumab, to Find the Optimal Dose for Patients, How the Drug is Tolerated and the Way the Body Absorbs, Distributes and Discharges the Drug Phase 1
Not yet recruiting NCT03692520 - Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCT200 in Patients With Advanced Solid Tumors Phase 1
Completed NCT02997176 - An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800) Phase 1
Recruiting NCT04446260 - A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors Phase 1
Recruiting NCT06239155 - A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Terminated NCT02253992 - An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma Phase 1/Phase 2
Recruiting NCT06076291 - An Open-label Study of SG1827 in Subjects With Advanced Solid Tumors Phase 1
Completed NCT03545971 - A Study of IBI310 for the Treatment of Patients With Advanced Solid Tumors. Phase 1

External Links