OncologyPhase 1NCT00352950
Safety Evaluation of Panitumumab and Sirolimus in Advanced Non-Small Cell Lung Cancer
A Phase 1 study testing AMG 954/Panitumumab in people with Oncology and Non-Small Cell Lung Cancer, run by Amgen.
Trial summary
To determine the dose and schedule of sirolimus when given in combination with panitumumab in adult subjects with Stage IIIB/IV NSCLC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology, Non-Small Cell Lung Cancer
- What is being tested?
- AMG 954/Panitumumab
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Feb 2008
- Phase
- Phase 1
- 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
- Histologically- or cytologically-confirmed diagnosis of stage IIIB or IV Non-Small Cell Lung Cancer
- Received only one prior treatment (not including radiation)
- Measurable disease per Response Evaluation Criteria in Solid Tumors Group (RECIST) guidelines
- Life expectancy of ≥ 4 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hematologic, renal and hepatic function
Show all 14Show fewer
- Serum-fasting cholesterol ≤ 300 mg/dL Serum-fasting triglycerides ≤ 2.5 X ULN Exclusion Criteria:
- Brain metastases requiring treatment
- History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline
- Systemic chemotherapy, radiotherapy, hormonal therapy or immunotherapy within 30 days before enrollment
- Prior epidermal growth factor receptor targeting agents with the exception of the small molecule EGFr tyrosine kinase inhibitors
- Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short serum half-life (less than 1 week) within 30 days before enrollment, or prior experimental or approved proteins/antibodies with longer serum half-life within 6 weeks before enrollment
- Prior therapy with sirolimus, sirolimus analogs
- Immunosuppressive agents within 28 days before enrollment
Who cannot join
None listed.
About this study
Official title: An Open-Label Clinical Trial Evaluating the Safety and Pharmacodynamics of Sirolimus and Panitumumab in Subjects With Advanced Non-Small Cell Lung Cancer
To determine the dose and schedule of sirolimus when given in combination with panitumumab in adult subjects with Stage IIIB/IV NSCLC
- Conditions
- Oncology, Non-Small Cell Lung Cancer
- Being tested
- AMG 954/Panitumumab
- Keywords
- NSCLC, Lung cancer, Panitumumab, Sirolimus, mTOR, Monoclonal antibody
- Medical subject headings
- Neoplasms, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 954/PanitumumabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
safety within the first 3 weeks
Secondary outcomes (1)
pharmacodynamic analysis of mTOR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2006 (estimated)
- Study startMar 2006
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352950
- Sponsor's protocol ID
- 20040145
- Status last verified
- Sep 2018
- First submitted
- 6 Apr 2006
- Last updated
- 6 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Clinical Trial Evaluating the Safety and Pharmacodynamics of Sirolimus and Panitumumab in Subjects With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00352950
- Acronym / sponsor ID
- 20040145
- Conditions
- Oncology, Non-Small Cell Lung Cancer
- Keywords
- NSCLC, Lung cancer, Panitumumab, Sirolimus, mTOR, Monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Study completion
- Feb 2008
- First posted
- 17 Jul 2006 (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.
To determine the dose and schedule of sirolimus when given in combination with panitumumab in adult subjects with Stage IIIB/IV NSCLC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically- or cytologically-confirmed diagnosis of stage IIIB or IV Non-Small Cell Lung Cancer
- Received only one prior treatment (not including radiation)
- Measurable disease per Response Evaluation Criteria in Solid Tumors Group (RECIST) guidelines
- Life expectancy of ≥ 4 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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 |
|---|---|---|
| AMG 954/Panitumumab | Drug | – |
Primary outcome
safety within the first 3 weeks
1 secondary outcome
pharmacodynamic analysis of mTOR
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 954/Panitumumab in people with Oncology and Non-Small Cell Lung Cancer, run by Amgen.
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 14 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: withdrawn, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
safety within the first 3 weeks. 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 6 Sep 2018.