NeoplasmsPhase 1NCT00225121
Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-00299804 In Patients With Advanced Solid Tumors
A Phase 1 study testing PF-00299804 in people with Neoplasms, run by Pfizer at 9 sites in 2 countries.
Trial summary
The primary purpose of this study is to study the side effects of PF-00299804 and determine the highest dose that can be safely administered in patients with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Neoplasms
- What is being tested?
- PF-00299804
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 11 Oct 2005to 23 Sep 2010
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Malignant solid tumor for which there is no currently approved treatment
- Adequate bone marrow, liver, cardiac, and kidney function
Who cannot join
- Cardiac disease
- Anticancer therapy within 4-6 weeks (depending on therapy)
- Pregnant or breast-feeding
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
University of Colorado Hospital
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
UCLA Hematology/Oncology
Los Angeles, California, 90095
UCLA Oncology Center
Los Angeles, California, 90095
UCLA Hematology Oncology - Santa Monica
Santa Monica, California, 90404
UCLA Santa Monica Hematology/Oncology
Santa Monica, California, 90404
Netherlands1 site
Vereniging het Nederlandse Kanker Instituut
Amsterdam, 1066 CX
About this study
Official title: A PHASE 1, OPEN-LABEL, DOSE-ESCALATION STUDY TO EVALUATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF 2 DOSING SCHEDULES OF PF-00299804 IN PATIENTS WITH ADVANCED MALIGNANT SOLID TUMORS
The primary purpose of this study is to study the side effects of PF-00299804 and determine the highest dose that can be safely administered in patients with advanced cancer.
- Conditions
- Neoplasms
- Being tested
- PF-00299804
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-00299804Drug
investigational drug by oral route (escalating doses depending on safety) administered until progression
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | open label single arm trial Receives: Drug: PF-00299804 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: 6 months
Secondary outcomes (3)
Pharmacokinetics
Measured: 6 months
Pharmacodynamics
Measured: 6 months
Efficacy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study start11 Oct 2005
- Primary completion3 Apr 2007
- Study completion23 Sep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies 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 1
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225121
- Sponsor's protocol ID
- A7471001
- Other IDs
- 2005-001140-23, 2005
- Status last verified
- Dec 2018
- First submitted
- 21 Sep 2005
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Publications
Janne PA, Boss DS, Camidge DR, Britten CD, Engelman JA, Garon EB, Guo F, Wong S, Liang J, Letrent S, Millham R, Taylor I, Eckhardt SG, Schellens JH. Phase I dose-escalation study of the pan-HER inhibitor, PF299804, in patients with advanced malignant solid tumors. Clin Cancer Res. 2011 Mar 1;17(5):1131-9. doi: 10.1158/1078-0432.CCR-10-1220. Epub 2011 Jan 10.
PubMed 21220471
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, DOSE-ESCALATION STUDY TO EVALUATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF 2 DOSING SCHEDULES OF PF-00299804 IN PATIENTS WITH ADVANCED MALIGNANT SOLID TUMORS
- ClinicalTrials.gov ID
- NCT00225121
- Acronym / sponsor ID
- A7471001
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2005 (actual)
- Primary completion
- 3 Apr 2007 (actual)
- Study completion
- 23 Sep 2010 (actual)
- First posted
- 23 Sep 2005 (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 primary purpose of this study is to study the side effects of PF-00299804 and determine the highest dose that can be safely administered in patients with advanced cancer.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PF-00299804open label single arm trial |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Malignant solid tumor for which there is no currently approved treatment
- Adequate bone marrow, liver, cardiac, and kidney function
Key exclusion criteria (3 listed)
- Cardiac disease
- Anticancer therapy within 4-6 weeks (depending on therapy)
- Pregnant or breast-feeding
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 |
|---|---|---|
| PF-00299804investigational drug by oral route (escalating doses depending on safety) administered until progression | Drug | 1 |
Primary outcome
Safety
Time frame: 6 months
3 secondary outcomes
Pharmacokinetics
Time frame: 6 months
Pharmacodynamics
Time frame: 6 months
Efficacy
Time frame: 6 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 21 Dec 2018.
- Derived from this study: PubMed 21220471Janne PA, Boss DS, Camidge DR, Britten CD, Engelman JA, Garon EB, Guo F, Wong S, Liang J, Letrent S, Millham R, Taylor I, Eckhardt SG, Schellens JH. Phase I dose-escalation study of the pan-HER inhibitor, PF299804, in patients with advanced malignant solid tumors. Clin Cancer Res. 2011 Mar 1;17(5):1131-9. doi: 10.1158/1078-0432.CCR-10-1220. Epub 2011 Jan 10.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-00299804 in people with Neoplasms, run by Pfizer at 9 sites in 2 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 2 inclusion and 3 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 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Netherlands. 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 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?
Safety (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00225121, which also lists 1 linked publication.
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 21 Dec 2018.