Non-Small Cell Lung CancerPhase 2NCT01024062
Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Paclitaxel in people with Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent non-small cell lung cancer Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to Mar 2005
- 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with no prior chemotherapy who meet either of the listed below:
- Patient with stage IIIB or IV disease
- Patients with recurrent disease following potentially curative surgical resection
- Patients with previous chemotherapy up to one regimen
Who cannot join
- Patients with serious, uncontrolled medical illness
- Patients with previous therapy with taxanes
About this study
The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent non-small cell lung cancer
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Paclitaxel
- 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.
PaclitaxelDrug
Also called Taxol, BMS-181339
Solution, IV, 100 mg/m², weekly for 6 of 7 weeks, until disease progression or unacceptable toxicity became apparent
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel | Experimental | Not described Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate [defined as total number of patients with complete and partial response divided by number of response-evaluable patients] based on "Response Evaluation Criteria in Solid Tumors (RECIST)" in patients with no prior chemotherapy
Measured: Each 49 day course of treatment until withdrawal or unacceptable toxicity
Safety: incidence and severity of adverse events, laboratory test abnormalities
Measured: Each 49 day course of treatment until withdrawal or unacceptable toxicity
Secondary outcomes (1)
Duration of response, [measured from the time that measurement criteria are met for complete or partial response until the first date that recurrent or progressive disease is objectively documents]
Measured: Each 49 day course of treatment until withdrawal or unacceptable toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startDec 2002
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024062
- Sponsor's protocol ID
- CA139-373
- Status last verified
- Apr 2011
- First submitted
- 30 Nov 2009
- Last updated
- 25 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT01024062
- Acronym / sponsor ID
- CA139-373
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 2 Dec 2009 (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 purpose of this study is to evaluate the efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent non-small cell lung cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel | Experimental | Drug: Paclitaxel |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with no prior chemotherapy who meet either of the listed below:
- Patient with stage IIIB or IV disease
- Patients with recurrent disease following potentially curative surgical resection
- Patients with previous chemotherapy up to one regimen
Key exclusion criteria (2 listed)
- Patients with serious, uncontrolled medical illness
- Patients with previous therapy with taxanes
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 |
|---|---|---|
| PaclitaxelAlso: Taxol, BMS-181339Solution, IV, 100 mg/m², weekly for 6 of 7 weeks, until disease progression or unacceptable toxicity became apparent | Drug | Paclitaxel |
Primary outcome
Response rate [defined as total number of patients with complete and partial response divided by number of response-evaluable patients] based on "Response Evaluation Criteria in Solid Tumors (RECIST)" in patients with no prior chemotherapy
Time frame: Each 49 day course of treatment until withdrawal or unacceptable toxicity
Safety: incidence and severity of adverse events, laboratory test abnormalities
Time frame: Each 49 day course of treatment until withdrawal or unacceptable toxicity
1 secondary outcome
Duration of response, [measured from the time that measurement criteria are met for complete or partial response until the first date that recurrent or progressive disease is objectively documents]
Time frame: Each 49 day course of treatment until withdrawal or unacceptable toxicity
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 25 Apr 2011.
Related trials for Non-Small Cell 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
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
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, 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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel in people with Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb.
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 4 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: finished, as of the sponsor's last update on 25 Apr 2011. 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 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 [defined as total number of patients with complete and partial response divided by number of response-evaluable patients] based on "Response Evaluation Criteria in Solid Tumors (RECIST)" in patients with no prior chemotherapy (time frame: Each 49 day course of treatment until withdrawal or unacceptable toxicity). The study lists 2 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 25 Apr 2011.