Trial record 2 of 2 for:    OSI-906-207

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier:
NCT02057380
First received: February 5, 2014
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Advanced Solid Tumors
Drug: linsitinib
Drug: erlotinib
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Open-label Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Number of subjects with adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Medium dose linsitinib twice daily monotherapy
Arm A includes subjects from Protocol OSI-906-301
Drug: linsitinib
oral
Other Name: OSI-906
Experimental: Arm B:Medium dose linsitinib twice daily plus high dose erlot
Arm B includes subjects from Protocol OSI-906-205
Drug: linsitinib
oral
Other Name: OSI-906
Drug: erlotinib
oral
Other Names:
  • Tarceva
  • OSI-774
Experimental: Arm C: High dose erlotinib monotherapy once daily
Arm C includes subjects from Protocol OSI-906-205 and OSI-906-207
Drug: erlotinib
oral
Other Names:
  • Tarceva
  • OSI-774
Experimental: Arm D:Medium dose linsitinib twice daily plus weekly paclitaxe
Arm D includes subjects from Protocol OSI-906-202
Drug: linsitinib
oral
Other Name: OSI-906
Drug: paclitaxel
Intravenous (IV) infusion
Experimental: Arm E:High dose linsitinib intermittent once daily on Days 1-3
Arm E includes subjects from Protocol OSI-906-202
Drug: linsitinib
oral
Other Name: OSI-906
Drug: paclitaxel
Intravenous (IV) infusion
Experimental: Arm F: Paclitaxel alone weekly
Arm F includes subjects from Protocol OSI-906-202
Drug: paclitaxel
Intravenous (IV) infusion
Experimental: Arm G: Low dose linsitinib twice daily plus low dose erlotinib
Arm G includes subjects from Protocol OSI-906-103
Drug: linsitinib
oral
Other Name: OSI-906
Drug: erlotinib
oral
Other Names:
  • Tarceva
  • OSI-774

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02057380

Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Investigators
Study Director: Executive Medical Director Astellas Pharma Global Development, Inc.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier: NCT02057380     History of Changes
Other Study ID Numbers: 7487-CL-0209, 2013-004076-34
Study First Received: February 5, 2014
Last Updated: March 13, 2014
Health Authority: Brazil: National Health Surveillance Agency
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Agency for Medicines and Medical Devices
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
Thailand: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Linsitinib
OSI-906
Erlotinib
OSI-774
Tarceva
Paclitaxel
Advanced Solid Tumor

Additional relevant MeSH terms:
Paclitaxel
Erlotinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014