Advanced Solid TumorsPhase 2NCT02057380
A Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial
A Phase 2 study testing linsitinib, erlotinib and paclitaxel in people with Advanced Solid Tumors, run by Astellas Pharma Global Development, Inc. at 12 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- linsitinib, erlotinib and paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 12 sitesin 7 countries
- Study dates
- 16 Apr 2014to 21 Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
12 sites in 7 countries.
12 sites in 7 countries
United States5 sites
Site US10008
Ann Arbor, Michigan, 48109
Site US10002
Baltimore, Maryland, 21287
Site US10004
La Jolla, California, 92093-0987
Site US10001
Oklahoma City, Oklahoma, 73104
Site US10006
Tampa, Florida, 33612
About this study
Official title: A Phase II Open-label Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial
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.
- Conditions
- Advanced Solid Tumors
- Being tested
- linsitinib, erlotinib, paclitaxel, Bortezomib, Dexamethasone
- Keywords
- Paclitaxel, Linsitinib, OSI-774, Advanced Solid Tumor, Tarceva, Erlotinib, OSI-906
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
linsitinibDrug
Also called OSI-906
oral
erlotinibDrug
Also called OSI-774, Tarceva
oral
paclitaxelDrug
Intravenous (IV) infusion
BortezomibDrug
Also called Velcade
Subcutaneous or IV
DexamethasoneDrug
Also called Maxidex, Baycadron, Ozurdex, Decadron
IV, Oral
| Study group | Role | What they receive |
|---|---|---|
| Arm A: High dose linsitinib twice daily monotherapy | Experimental | Arm A includes subjects from Protocol OSI-906-301 Receives: Drug: linsitinib |
| Arm B: High dose linsitinib BID plus high dose erlotinib QD | Experimental | Arm B includes subjects from Protocol OSI-906-205 Receives: Drug: linsitinib; Drug: erlotinib |
| Arm C: High dose erlotinib monotherapy once daily | Experimental | Arm C includes subjects from Protocol OSI-906-205 and OSI-906-207 Receives: Drug: erlotinib |
| Arm D: High dose linsitinib BID plus weekly paclitaxel | Experimental | Arm D includes subjects from Protocol OSI-906-202 Receives: Drug: linsitinib; Drug: paclitaxel |
| Arm E: Highest dose linsitinib intermittent once daily | Experimental | Arm E includes subjects from Protocol OSI-906-202, linsitinib on Days 1-3 of each week plus weekly paclitaxel Receives: Drug: linsitinib; Drug: paclitaxel |
| Arm F: Paclitaxel alone weekly | Experimental | Arm F includes subjects from Protocol OSI-906-202 Receives: Drug: paclitaxel |
| Arm G: Lowest dose linsitinib twice daily + low dose erlotinib | Experimental | Arm G includes subjects from Protocol OSI-906-103 Receives: Drug: linsitinib; Drug: erlotinib |
| Arm H: high dose linsitinib twice daily | Experimental | includes subjects from protocols SARC 022/CTEP 8945, linsitinib x28 days (each cycle) Receives: Drug: linsitinib |
| Arm I: highest dose linsitinib once daily | Experimental | includes subjects from EuroSARC protocol, linsitinib on Days 1-3; Days 8-10 and Days 15-17 Receives: Drug: linsitinib |
| Arm J: Low dose linsitinib 2x daily+bortezomib & dexamethasone | Experimental | includes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+) Receives: Drug: linsitinib; Drug: Bortezomib; Drug: Dexamethasone |
| Arm K: med. dose linsitinib 2x daily+bortezomib&dexamethasone | Experimental | includes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+) Receives: Drug: linsitinib; Drug: Bortezomib; Drug: Dexamethasone |
| Arm L: high dose linsitinib 2x daily+bortezomib&dexamethasone | Experimental | includes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+) Receives: Drug: linsitinib; Drug: Bortezomib; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study start16 Apr 2014
- Primary completion14 Oct 2016
- Study completion21 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Executive Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057380
- Sponsor's protocol ID
- 7487-CL-0209
- Other IDs
- 2013-004076-34
- Status last verified
- Nov 2024
- First submitted
- 5 Feb 2014
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open-label Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial
- ClinicalTrials.gov ID
- NCT02057380
- Acronym / sponsor ID
- 7487-CL-0209
- Conditions
- Advanced Solid Tumors
- Keywords
- Paclitaxel, Linsitinib, OSI-774, Advanced Solid Tumor, Tarceva, Erlotinib, OSI-906
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2014 (actual)
- Primary completion
- 14 Oct 2016 (actual)
- Study completion
- 21 Dec 2016 (actual)
- First posted
- 7 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Arm A: High dose linsitinib twice daily monotherapy | Experimental | Drug: linsitinibArm A includes subjects from Protocol OSI-906-301 |
| Arm B: High dose linsitinib BID plus high dose erlotinib QD | Experimental | Drug: linsitinib, Drug: erlotinibArm B includes subjects from Protocol OSI-906-205 |
| Arm C: High dose erlotinib monotherapy once daily | Experimental | Drug: erlotinibArm C includes subjects from Protocol OSI-906-205 and OSI-906-207 |
| Arm D: High dose linsitinib BID plus weekly paclitaxel | Experimental | Drug: linsitinib, Drug: paclitaxelArm D includes subjects from Protocol OSI-906-202 |
| Arm E: Highest dose linsitinib intermittent once daily | Experimental | Drug: linsitinib, Drug: paclitaxelArm E includes subjects from Protocol OSI-906-202, linsitinib on Days 1-3 of each week plus weekly paclitaxel |
| Arm F: Paclitaxel alone weekly | Experimental | Drug: paclitaxelArm F includes subjects from Protocol OSI-906-202 |
| Arm G: Lowest dose linsitinib twice daily + low dose erlotinib | Experimental | Drug: linsitinib, Drug: erlotinibArm G includes subjects from Protocol OSI-906-103 |
| Arm H: high dose linsitinib twice daily | Experimental | Drug: linsitinibincludes subjects from protocols SARC 022/CTEP 8945, linsitinib x28 days (each cycle) |
| Arm I: highest dose linsitinib once daily | Experimental | Drug: linsitinibincludes subjects from EuroSARC protocol, linsitinib on Days 1-3; Days 8-10 and Days 15-17 |
| Arm J: Low dose linsitinib 2x daily+bortezomib & dexamethasone | Experimental | Drug: linsitinib, Drug: Bortezomib, Drug: Dexamethasoneincludes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+) |
| Arm K: med. dose linsitinib 2x daily+bortezomib&dexamethasone | Experimental | Drug: linsitinib, Drug: Bortezomib, Drug: Dexamethasoneincludes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+) |
| Arm L: high dose linsitinib 2x daily+bortezomib&dexamethasone | Experimental | Drug: linsitinib, Drug: Bortezomib, Drug: Dexamethasoneincludes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| linsitinibAlso: OSI-906oral | Drug | Arm A: High dose linsitinib twice daily monotherapy, Arm B: High dose linsitinib BID plus high dose erlotinib QD, Arm D: High dose linsitinib BID plus weekly paclitaxel, Arm E: Highest dose linsitinib intermittent once daily, Arm G: Lowest dose linsitinib twice daily + low dose erlotinib, Arm H: high dose linsitinib twice daily, Arm I: highest dose linsitinib once daily, Arm J: Low dose linsitinib 2x daily+bortezomib & dexamethasone, Arm K: med. dose linsitinib 2x daily+bortezomib&dexamethasone, Arm L: high dose linsitinib 2x daily+bortezomib&dexamethasone |
| erlotinibAlso: OSI-774, Tarcevaoral | Drug | Arm B: High dose linsitinib BID plus high dose erlotinib QD, Arm C: High dose erlotinib monotherapy once daily, Arm G: Lowest dose linsitinib twice daily + low dose erlotinib |
| paclitaxelIntravenous (IV) infusion | Drug | Arm D: High dose linsitinib BID plus weekly paclitaxel, Arm E: Highest dose linsitinib intermittent once daily, Arm F: Paclitaxel alone weekly |
| BortezomibAlso: VelcadeSubcutaneous or IV | Drug | Arm J: Low dose linsitinib 2x daily+bortezomib & dexamethasone, Arm K: med. dose linsitinib 2x daily+bortezomib&dexamethasone, Arm L: high dose linsitinib 2x daily+bortezomib&dexamethasone |
| DexamethasoneAlso: Maxidex, Baycadron, Ozurdex, DecadronIV, Oral | Drug | Arm J: Low dose linsitinib 2x daily+bortezomib & dexamethasone, Arm K: med. dose linsitinib 2x daily+bortezomib&dexamethasone, Arm L: high dose linsitinib 2x daily+bortezomib&dexamethasone |
Primary outcome
Number of subjects with adverse events
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Related trials for Advanced Solid Tumors
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
RecruitingPhase 1/2
A 2-part Phase 1/2 Open-label Trial on ODM-212
Mesothelioma, Pancreatic Cancer
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Executive Medical Director study director
Astellas Pharma Global Development, Inc.
12 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing linsitinib, erlotinib and paclitaxel in people with Advanced Solid Tumors, run by Astellas Pharma Global Development, Inc. at 12 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Germany, Brazil, Czechia, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.