Carcinoma, Non-Small Cell LungPhase 2NCT00321308
Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing pemetrexed and pemetrexed + PF-3512676 in people with Carcinoma, Non-Small Cell Lung, run by Pfizer at 20 sites in 3 countries.
Trial summary
To assess the efficacy and safety of PF-3512676 administered in combination with pemetrexed for the treatment of patients with locally advanced or metastatic NSCLC who have failed one prior chemotherapy regimen 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?
- pemetrexed and pemetrexed + PF-3512676
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 20 sitesin 3 countries
- Study dates
- Sep 2006to Jan 2008
- 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
- Locally advanced or metastatic NSCLC
- Measurable disease
- ECOG PS 0 or 1
Who cannot join
- Known CNS metastasis
- Pre-existing autoimmune or antibody mediated disease
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
United States17 sites
Pfizer Investigational Site
Bentonville, Arkansas, 72712
Pfizer Investigational Site
Fayetteville, Arkansas, 72703
Pfizer Investigational Site
Hudson, Florida, 34667
Pfizer Investigational Site
Litchfield Park, Arizona, 85340
Pfizer Investigational Site
Mahwah, New Jersey, 07430
Pfizer Investigational Site
Midland Park, New Jersey, 07432
Pfizer Investigational Site
New Port Richey, Florida, 34655
Pfizer Investigational Site
Oneida, New York, 13421
Pfizer Investigational Site
Oswego, New York, 13126
Pfizer Investigational Site
Paramus, New Jersey, 07652
Pfizer Investigational Site
Seattle, Washington, 89109
Pfizer Investigational Site
Seattle, Washington, 98195
Pfizer Investigational Site
Sun City, Arizona, 85351
Pfizer Investigational Site
Sylvania, Ohio, 43560
Pfizer Investigational Site
Syracuse, New York, 13210-2306
Pfizer Investigational Site
Syracuse, New York, 13210
Pfizer Investigational Site
Westwood, New Jersey, 07675
Germany2 sites
Pfizer Investigational Site
Großhansdorf, 22927
Pfizer Investigational Site
Mannheim, 68167
About this study
Official title: A Randomized Phase II Trial Of Pemetrexed With Or Without PF-3512676 For The Treatment Of Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer After Failure Of One Prior Chemotherapy Regimen For Advanced Disease
To assess the efficacy and safety of PF-3512676 administered in combination with pemetrexed for the treatment of patients with locally advanced or metastatic NSCLC who have failed one prior chemotherapy regimen
Read the detailed description
PF-3512676 dosing was stopped 21 June 2007 when Pfizer decided to stop the administration of PF-3512676 in all trials which combined PF-3512676 with cytotoxic chemotherapy. The decision was made subsequent to DSMC recommendation to close two phase III randomized trials in non-small cell lung cancer which also combined PF-3512676 with cytotoxic chemotherapy, citing lack of efficacy concerns as the primary reason with safety issues (sepsis, thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment and protocol follow-up. Data collection was completed on 31 January 2008.
- Conditions
- Carcinoma, Non-Small Cell Lung
- Being tested
- pemetrexed, pemetrexed + PF-3512676
- Keywords
- advanced carcinoma, non-small cell lung cancer, phase II, pemetrexed, Alimta, PF-3512676, immunotherapy, immunomodulator
- 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.
pemetrexedDrug
Also called Alimta
500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity
pemetrexed + PF-3512676Drug
Also called Alimta
pemetrexed 500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| B | Active comparator | Standard of care chemotherapy Receives: Drug: pemetrexed |
| A | Experimental | Standard of care chemotherapy plus experimental intervention (PF-3512676) Receives: Drug: pemetrexed + PF-3512676 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 110 Events
Secondary outcomes (6)
Overall Survival
Measured: Time of death
Overall Safety Profile
Measured: 28 days post treatment
Patient Reported Outcome
Measured: End of Treatment
Time to Tumor Progression
Measured: End of treatment
Overall Objective Response Rate
Measured: Time of disease progressive disease
Duration of Response
Measured: Time of disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startSep 2006
- Primary completionJan 2008
- Study completionJan 2008
Why it stopped: See Termination Reason in Detailed Description.
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 PfizerThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321308
- Sponsor's protocol ID
- A8501004
- Status last verified
- Sep 2009
- First submitted
- 2 May 2006
- Last updated
- 28 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial Of Pemetrexed With Or Without PF-3512676 For The Treatment Of Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer After Failure Of One Prior Chemotherapy Regimen For Advanced Disease
- ClinicalTrials.gov ID
- NCT00321308
- Acronym / sponsor ID
- A8501004
- Conditions
- Carcinoma, Non-Small Cell Lung
- Keywords
- advanced carcinoma, non-small cell lung cancer, phase II, pemetrexed, Alimta, PF-3512676, immunotherapy, immunomodulator
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See Termination Reason in Detailed Description.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 3 May 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 assess the efficacy and safety of PF-3512676 administered in combination with pemetrexed for the treatment of patients with locally advanced or metastatic NSCLC who have failed one prior chemotherapy regimen
Detailed description
PF-3512676 dosing was stopped 21 June 2007 when Pfizer decided to stop the administration of PF-3512676 in all trials which combined PF-3512676 with cytotoxic chemotherapy. The decision was made subsequent to DSMC recommendation to close two phase III randomized trials in non-small cell lung cancer which also combined PF-3512676 with cytotoxic chemotherapy, citing lack of efficacy concerns as the primary reason with safety issues (sepsis, thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment and protocol follow-up. Data collection was completed on 31 January 2008.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Active comparator | Drug: pemetrexedStandard of care chemotherapy |
| A | Experimental | Drug: pemetrexed + PF-3512676Standard of care chemotherapy plus experimental intervention (PF-3512676) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Locally advanced or metastatic NSCLC
- Measurable disease
- ECOG PS 0 or 1
Key exclusion criteria (2 listed)
- Known CNS metastasis
- Pre-existing autoimmune or antibody mediated disease
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 |
|---|---|---|
| pemetrexedAlso: Alimta500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity | Drug | B |
| pemetrexed + PF-3512676Also: Alimtapemetrexed 500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity | Drug | A |
Primary outcome
Progression-free survival
Time frame: 110 Events
6 secondary outcomes
Overall Survival
Time frame: Time of death
Overall Safety Profile
Time frame: 28 days post treatment
Patient Reported Outcome
Time frame: End of Treatment
Time to Tumor Progression
Time frame: End of treatment
Overall Objective Response Rate
Time frame: Time of disease progressive disease
Duration of Response
Time frame: Time of disease progression
Results and safety
The study was stopped early (reason given: See Termination Reason in Detailed Description.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2009.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pemetrexed and pemetrexed + PF-3512676 in people with Carcinoma, Non-Small Cell Lung, run by Pfizer at 20 sites in 3 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 2 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: stopped early, as of the sponsor's last update on 28 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Germany, Italy. 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 was stopped early (reason given: See Termination Reason in Detailed Description.). Results are not available in the source record.
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?
Progression-free survival (time frame: 110 Events). 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 28 Sep 2009.