Lung CancerPhase 2NCT00456716
Sorafenib in BAC or Never-Smokers With Lung Adenocarcinoma
A Phase 2 study testing sorafenib in people with Lung Cancer, run by Swedish Medical Center at 1 site in United States.
Trial summary
Open label study of sorafenib Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- sorafenib
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Dec 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
- Age > 18
- Life expectancy > 12 weeks
- Biopsy-proven BAC or adenocarcinoma
- Willing to provide smoking status
- Selected IIIB or stage IV cancer that is incompletely resected or unresectable
Who cannot join
- O2 saturation < 88% on room air
- Pregnant or nursing women
- Surgery or radiation therapy within 4 weeks of starting study
- Major heart condition within 6 months of starting therapy
- Certain concomitant medications prohibited
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial of Sorafenib in BAC or Never-Smokers With Any Lung Adenocarcinoma
Open label study of sorafenib
Read the detailed description
Open label study using oral sorafenib 800 mg daily in any stage III-IV BAC lung cancer and Stage III-IV adenocarcinoma of the lung in nonsmokers (less than < 100 cigarettes lifetime).
- Conditions
- Lung Cancer
- Being tested
- sorafenib
- Keywords
- BAC lung cancer, adenocarcinoma of the lung
- Medical subject headings
- Lung Neoplasms, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sorafenibDrug
Also called BAY 43-9006
400mg po bid
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: January 2009
One-year survival
Measured: January 2009
Median survival
Measured: January 2009
Secondary outcomes (2)
Median progression-free survival
Measured: January 2009
Toxicities
Measured: January 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Howard J West, M.D., Principal investigator, Swedish Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456716
- Sponsor's protocol ID
- CRC 0639
- Status last verified
- Mar 2010
- First submitted
- 3 Apr 2007
- Last updated
- 4 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Sorafenib in BAC or Never-Smokers With Any Lung Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00456716
- Acronym / sponsor ID
- CRC 0639
- Conditions
- Lung Cancer
- Keywords
- BAC lung cancer, adenocarcinoma of the lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Collaborators
- Bayer, Amgen
- Study start
- Mar 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 Apr 2007 (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.
Open label study of sorafenib
Detailed description
Open label study using oral sorafenib 800 mg daily in any stage III-IV BAC lung cancer and Stage III-IV adenocarcinoma of the lung in nonsmokers (less than < 100 cigarettes lifetime).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-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 (5 listed)
- Age > 18
- Life expectancy > 12 weeks
- Biopsy-proven BAC or adenocarcinoma
- Willing to provide smoking status
- Selected IIIB or stage IV cancer that is incompletely resected or unresectable
Key exclusion criteria (5 listed)
- O2 saturation < 88% on room air
- Pregnant or nursing women
- Surgery or radiation therapy within 4 weeks of starting study
- Major heart condition within 6 months of starting therapy
- Certain concomitant medications prohibited
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 |
|---|---|---|
| sorafenibAlso: BAY 43-9006400mg po bid | Drug | – |
Primary outcome
Response rate
Time frame: January 2009
One-year survival
Time frame: January 2009
Median survival
Time frame: January 2009
2 secondary outcomes
Median progression-free survival
Time frame: January 2009
Toxicities
Time frame: January 2009
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 Mar 2010.
- Swedish Medical Center Research StudiesLink provided by the sponsor.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Howard J West, M.D. principal investigator
Swedish Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sorafenib in people with Lung Cancer, run by Swedish Medical Center at 1 site in United States.
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 5 inclusion and 5 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 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Response rate (time frame: January 2009). The study lists 3 primary outcomes in all. 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 Mar 2010.