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

Part of paid clinical trials in La Jolla, California.

Sponsor
Astellas Pharma Global Development, Inc.
Study ID
NCT02057380
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Feb 7, 2014
Start date
Apr 16, 2014
Status verified
Nov 2024
Primary completion
Oct 14, 2016
Completion
Dec 21, 2016

Study Design

Enrollment
13 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: High dose linsitinib twice daily monotherapy
    Arm A includes subjects from Protocol OSI-906-301
  • Experimental: Arm B: High dose linsitinib BID plus high dose erlotinib QD
    Arm B includes subjects from Protocol OSI-906-205
  • Experimental: Arm C: High dose erlotinib monotherapy once daily
    Arm C includes subjects from Protocol OSI-906-205 and OSI-906-207
  • Experimental: Arm D: High dose linsitinib BID plus weekly paclitaxel
    Arm D includes subjects from Protocol OSI-906-202
  • Experimental: Arm E: Highest dose linsitinib intermittent once daily
    Arm E includes subjects from Protocol OSI-906-202, linsitinib on Days 1-3 of each week plus weekly paclitaxel
  • Experimental: Arm F: Paclitaxel alone weekly
    Arm F includes subjects from Protocol OSI-906-202
  • Experimental: Arm G: Lowest dose linsitinib twice daily + low dose erlotinib
    Arm G includes subjects from Protocol OSI-906-103
  • Experimental: Arm H: high dose linsitinib twice daily
    includes subjects from protocols SARC 022/CTEP 8945, linsitinib x28 days (each cycle)
  • Experimental: Arm I: highest dose linsitinib once daily
    includes subjects from EuroSARC protocol, linsitinib on Days 1-3; Days 8-10 and Days 15-17
  • Experimental: Arm J: Low dose linsitinib 2x daily+bortezomib & dexamethasone
    includes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+)
  • Experimental: Arm K: med. dose linsitinib 2x daily+bortezomib&dexamethasone
    includes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+)
  • Experimental: Arm L: high dose linsitinib 2x daily+bortezomib&dexamethasone
    includes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+)

Primary Outcome Measure

Number of subjects with adverse events [ Time Frame: 24 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Site US10004La JollaCalifornia92093-0987-
Site US10006TampaFlorida33612-
Site US10002BaltimoreMaryland21287-
Site US10008Ann ArborMichigan48109-
Site US10001Oklahoma CityOklahoma73104-

Find similar trials in La Jolla, CA

By research site
Site US10004· La Jolla, CASite US10006· Tampa, FLSite US10002· Baltimore, MDSite US10008· Ann Arbor, MISite US10001· Oklahoma City, OK

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