Carcinoma, Non-small Cell LungPhase 1NCT00729742
Phase I Imaging Study Evaluating Dalotuzumab (MK0646) in Combination With Erlotinib for Patients With Non-Small Cell Lung Cancer (MK-0646-008)
A Phase 1 study testing Comparator: erlotinib + dalotuzumab and Comparator: erlotinib monotherapy in people with Carcinoma, Non-small Cell Lung, run by Merck Sharp & Dohme LLC.
Trial summary
This study will use imaging to look at tumor response to erlotinib (Part I) and the combination of erlotinib and dalotuzumab (Part II). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-small Cell Lung
- What is being tested?
- Comparator: erlotinib + dalotuzumab and Comparator: erlotinib monotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to May 2011
- 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
- Patient has locally advanced or metastatic stage IIIB/IV Non-small cell lung cancer
- Patient has measurable disease
- Patient has accessible tumor and consents to undergo a tumor biopsy [Part II only]
- Patient is 18 years of age or older
- Patient has a performance status of 0-2 on ECOG scale
- Women of childbearing potential have a negative pregnancy test
- Patients in Part I must: 1. be a female non-smoker with non-squamous histology who has had one or two prior systemic chemotherapies or 2. have documented EGFR mutation or EGFR gene amplification, regardless of demographic or clinical characteristics, who have had no more than two prior systemic chemotherapies.
- Patients in Part II must have had one or two chemotherapy regimens for recurrent or metastatic disease
Who cannot join
- Patient has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab) within 4 weeks
- Patient has not recovered from adverse events from previous therapy within 4 weeks
- Patient has received EGFR-TKI inhibitor/anti-EGFR mAb therapy
- Patient has received IGF1R-TKI inhibitor/anti-IGF1R mAB therapy
- Patient has untreated brain metastases
- Patient has had radiotherapy to a field that affects the chest or abdomen, or thoracic surgery within 3 months prior to entering the study
Show all 13Show fewer
- Patient is taking part in another clinical study
- Patient abuses drugs or alcohol
- Patient is pregnant or breastfeeding
- Subject is HIV positive
- Patient has active hepatitis
- Patient is using growth hormone or growth hormone inhibitors
- Patient has poorly controlled diabetes mellitus
About this study
Official title: A Phase 1b, Multicenter Trial to Evaluate Molecular Determinants of Response to Erlotinib and MK0646 in Advanced Non-Small-Cell Lung Cancer
This study will use imaging to look at tumor response to erlotinib (Part I) and the combination of erlotinib and dalotuzumab (Part II).
- Conditions
- Carcinoma, Non-small Cell Lung
- Being tested
- Comparator: erlotinib + dalotuzumab, Comparator: erlotinib monotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: erlotinib + dalotuzumabDrug
Also called TARCEVA®
Part II: All patients will receive 1 week of erlotinib 150 mg tablets per day.
Arm 1: Patients who experience a PET response will continue on erlotinib monotherapy until disease progression.
Arm 2: Patients who fail to receive a PET response will continue to take erlotinib in combination with dalotuzumab 10 mg/kg IV infusion once weekly. At the time of disease progression, patients on erlotinib monotherapy will be offered to crossover to dalotuzumab 10 mg/kg IV infusion once weekly in combination with erlotinib.
Comparator: erlotinib monotherapyDrug
Also called TARCEVA®
Part I: All patients will receive erlotinib 150 mg tablets per day until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | erlotinib Receives: Drug: Comparator: erlotinib monotherapy |
| Part 2 | Experimental | erlotinib + dalotuzumab Receives: Drug: Comparator: erlotinib + dalotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate imaging platform and molecular markers
Measured: FDG response at Weeks 1 and 3 following chemotherapy
Secondary outcomes (1)
Progression-free survival, overall survival
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2008 (estimated)
- Study startFeb 2009
- Primary completionJun 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-small Cell LungStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729742
- Sponsor's protocol ID
- 0646-008
- Other IDs
- 2008_518, CTRI/2009/091/000139
- Status last verified
- Apr 2016
- First submitted
- 4 Aug 2008
- Last updated
- 4 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Multicenter Trial to Evaluate Molecular Determinants of Response to Erlotinib and MK0646 in Advanced Non-Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00729742
- Acronym / sponsor ID
- 0646-008
- Conditions
- Carcinoma, Non-small Cell Lung
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 Aug 2008 (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.
This study will use imaging to look at tumor response to erlotinib (Part I) and the combination of erlotinib and dalotuzumab (Part II).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: Comparator: erlotinib monotherapyerlotinib |
| Part 2 | Experimental | Drug: Comparator: erlotinib + dalotuzumaberlotinib + dalotuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient has locally advanced or metastatic stage IIIB/IV Non-small cell lung cancer
- Patient has measurable disease
- Patient has accessible tumor and consents to undergo a tumor biopsy [Part II only]
- Patient is 18 years of age or older
- Patient has a performance status of 0-2 on ECOG scale
Key exclusion criteria (13 listed)
- Patient has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab) within 4 weeks
- Patient has not recovered from adverse events from previous therapy within 4 weeks
- Patient has received EGFR-TKI inhibitor/anti-EGFR mAb therapy
- Patient has received IGF1R-TKI inhibitor/anti-IGF1R mAB therapy
- Patient has untreated brain metastases
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 |
|---|---|---|
| Comparator: erlotinib + dalotuzumabAlso: TARCEVA®Part II: All patients will receive 1 week of erlotinib 150 mg tablets per day. Arm 1: Patients who experience a PET response will continue on erlotinib monotherapy until disease progression. Arm 2: Patients who fail to receive a PET response will continue to take erlotinib in combination with dalotuzumab 10 mg/kg IV infusion once weekly. At the time of disease progression, patients on erlotinib monotherapy will be offered to crossover to dalotuzumab 10 mg/kg IV infusion once weekly in combination with erlotinib. | Drug | Part 2 |
| Comparator: erlotinib monotherapyAlso: TARCEVA®Part I: All patients will receive erlotinib 150 mg tablets per day until disease progression. | Drug | Part 1 |
Primary outcome
Validate imaging platform and molecular markers
Time frame: FDG response at Weeks 1 and 3 following chemotherapy
1 secondary outcome
Progression-free survival, overall survival
Time frame: 3 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 4 Apr 2016.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Comparator: erlotinib + dalotuzumab and Comparator: erlotinib monotherapy in people with Carcinoma, Non-small Cell Lung, run by Merck Sharp & Dohme LLC.
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 8 inclusion and 13 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 4 Apr 2016. 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 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?
Validate imaging platform and molecular markers (time frame: FDG response at Weeks 1 and 3 following chemotherapy). 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 4 Apr 2016.