Stage IV NSCLCPhase 2NCT01640730
Safety and Exploratory Efficacy of Kanglaite Injection in Non Small Cell Lung Cancer
A Phase 2 study testing Kanglaite Injection in people with Stage IV NSCLC, run by KangLaiTe USA at 1 site in United States.
Trial summary
This study is for patients with advanced non small cell lung cancer that has progressed despite standard of care. The purpose of the study is to see if Kanglaite injection has any effect on survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV NSCLC
- What is being tested?
- Kanglaite Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Oct 2012
- 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
- confirmed (within last 3 months)progressive Stage IV NSCLC
- estimated life span of 3 months
- phase angle of at least 5 as measured by bioimpedance
Who cannot join
- currently taking a lipid lowering medications
- has an imminently life threatening condition
- has pre-existing liver disease
- known allergy to soybeans
- uncontrolled diabetes or uncontrolled disturbance of lipid metabolism
- pregnant or lactating
- has a pacemaker or other implantable electronic medical device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Safety and Exploratory Efficacy Study of Kanglaite Injection in Patients Having Progressive Stage IV NSCLC Who Are Not Candidates for Other Anti-cancer Treatment
This study is for patients with advanced non small cell lung cancer that has progressed despite standard of care. The purpose of the study is to see if Kanglaite injection has any effect on survival.
- Conditions
- Stage IV NSCLC
- Being tested
- Kanglaite Injection
- 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.
Kanglaite InjectionDrug
Also called KLTi
30gm IV infusion 5 days a week for 3 weeks every 28 days
| Study group | Role | What they receive |
|---|---|---|
| Kanglaite injection | Experimental | Not described Receives: Drug: Kanglaite Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: from date of enrollment until date of death from any cause assessed up to 12 months
Secondary outcomes (2)
Bioimpedance Phase Angle
Measured: measured each month up to one year
Palliation Response Measure
quality of life survey and performance status
Measured: each month up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV NSCLCStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- KangLaiTe USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640730
- Sponsor's protocol ID
- KLT-NSCLC-004
- Status last verified
- Jan 2014
- First submitted
- 15 Jun 2012
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Safety and Exploratory Efficacy Study of Kanglaite Injection in Patients Having Progressive Stage IV NSCLC Who Are Not Candidates for Other Anti-cancer Treatment
- ClinicalTrials.gov ID
- NCT01640730
- Acronym / sponsor ID
- KLT-NSCLC-004
- Conditions
- Stage IV NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- KangLaiTe USAIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 16 Jul 2012 (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 is for patients with advanced non small cell lung cancer that has progressed despite standard of care. The purpose of the study is to see if Kanglaite injection has any effect on survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kanglaite injection | Experimental | Drug: Kanglaite Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- confirmed (within last 3 months)progressive Stage IV NSCLC
- estimated life span of 3 months
- phase angle of at least 5 as measured by bioimpedance
Key exclusion criteria (7 listed)
- currently taking a lipid lowering medications
- has an imminently life threatening condition
- has pre-existing liver disease
- known allergy to soybeans
- uncontrolled diabetes or uncontrolled disturbance of lipid metabolism
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 |
|---|---|---|
| Kanglaite InjectionAlso: KLTi30gm IV infusion 5 days a week for 3 weeks every 28 days | Drug | Kanglaite injection |
Primary outcome
Overall Survival
Time frame: from date of enrollment until date of death from any cause assessed up to 12 months
2 secondary outcomes
Bioimpedance Phase Angle
Time frame: measured each month up to one year
Palliation Response Measure
Time frame: each month up to one year
Results and safety
The study was stopped early (reason given: poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Kanglaite Injection in people with Stage IV NSCLC, run by KangLaiTe USA 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 3 inclusion and 7 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 16 Jan 2014. 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 was stopped early (reason given: poor enrollment). 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?
Overall Survival (time frame: from date of enrollment until date of death from any cause assessed up to 12 months). 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 16 Jan 2014.