KRAS Positive Patients With Non-small Cell Lung CancerPhase 2NCT02283320
A Study of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy for Patients With KRAS Positive or Squamous Cell Non-Small Cell Lung Cancer
A Phase 2 study testing BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) in people with KRAS Positive Patients With Non-small Cell Lung Cancer and Squamous Cell Non-small Cell Lung Cancer, run by BIND Therapeutics at 32 sites in 2 countries.
Trial summary
BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients with v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive or squamous cell non-small cell lung cancer (NSCLC) who have progressed after treatment of one prior platinum-containing chemotherapy regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- KRAS Positive Patients With Non-small Cell Lung Cancer, Squamous Cell Non-small Cell Lung Cancer
- What is being tested?
- BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 32 sitesin 2 countries
- Study dates
- Sep 2014to Apr 2016
- 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
- Males or females at least 18 years of age
- Diagnosis of NSCLC with locally advanced or metastatic disease
- Positive for KRAS mutation or Squamous cell histology
- Previously treated with one platinum-based chemotherapy
- Disease status must be that of measurable and/or evaluable disease
- Performance status of 0 to 1 on the ECOG Scale
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- Prior chemotherapy completed at least 3 weeks prior to study enrollment
- Prior radiation therapy allowed to < 25% of the bone marrow
- Patient compliance and geographic proximity that allow adequate follow-up
- Adequate organ function
- Patients with reproductive potential must use contraceptive methods
- Signed informed consent from patient
Who cannot join
- Active infection
- Pregnancy or planning to become pregnant
- Breast feeding
- Serious concomitant systemic disorders
- Second primary malignancy
- Patients who are symptomatic from brain metastasis
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- Presence of detectable (by physical exam) third-space fluid collections
- More than 1 prior cytotoxic chemotherapy regimen for advanced disease
- Prior treatment with docetaxel
- History of severe hypersensitivity reaction to polysorbate 80
- Peripheral neuropathy at study entry
- Patients known to be HIV positive
- Patients known to be seropositive for hepatitis C hepatitis B
- Congenital long QT syndrome, congestive heart failure, or bradyarrhythmia
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States22 sites
Investigative Site: #39
Amarillo, Texas, 79106
Investigative Site: #40
Blacksburg, Virginia, 24060
Investigative Site: #51
Chandler, Arizona, 85224
Investigative Site: #42
Dallas, Texas, 75231
Investigative Site: 38
Dallas, Texas, 75237
Investigative Site: #58
Duarte, California, 91010
Investigative Site: #46
Fort Meyers, Florida, 33916
Investigative Site: #30
Goodyear, Arizona, 85338
Investigative Site: #47
La Jolla, California, 92093
Investigative Site: #36
Las Vegas, Nevada, 89119
Investigative Site: #32
Los Angeles, California, 90048
Investigative Site: #53
Newnan, Georgia, 30265
Investigative Site: #44
Phoenix, Arizona, 85016
Investigative Site: #34
Pittsburgh, Pennsylvania, 15232
Investigative Site: # 59
Pittsburgh, Pennsylvania, 15240
Investigative Site: #60
Portland, Oregon, 97239
Investigative Site: #50
San Francisco, California, 94115
Investigative Site: #56
Savannah, Georgia, 31405
Investigative Site: #41
Sedona, Arizona, 86336
Investigative Site: #45
Vancouver, Washington, 98684
Investigative Site: #37
Yakima, Washington, 98902
Investigative Site: #35
Zion, Illinois, 60099
Russia10 sites
Investigative Site: #74
Arkhangelsk, 163045
Investigative Site: #75
Istra Settle., Moscow Oblast, 143423
Investigative Site: #78
Kazan', 420029
Investigative Site: #70
Moscow, 115478
Investigative Site: #79
Rostov-on-Don, 603024
Investigative Site: #76
Saint Petersburg, 197022
Investigative Site: #71
Saint Petersburg, 197758
Investigative Site: #73
Saint Petersburg, 197758
Investigative Site: #77
Saint Petersburg, 198255
Investigative Site: #72
Ufa, Bashkortastan, 450054
About this study
Official title: An Open Label, Multicenter, Phase 2 Study to Determine the Safety and Efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as a Second-Line Therapy for Patients With KRAS Mutation Positive or Squamous Cell Non-Small Cell Lung Cancer
BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients with v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive or squamous cell non-small cell lung cancer (NSCLC) who have progressed after treatment of one prior platinum-containing chemotherapy regimen.
- Conditions
- KRAS Positive Patients With Non-small Cell Lung Cancer, Squamous Cell Non-small Cell Lung Cancer
- Being tested
- BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)Drug
| Study group | Role | What they receive |
|---|---|---|
| BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) | Experimental | Not described Receives: Drug: BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate
Measured: Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks
Secondary outcomes (7)
Progression-free survival
Measured: Change in tumor size will be assessed using RECIST measurements. RECIST assessments will be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average of 18 weeks.
Overall survival
Measured: Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation
Duration of response
Measured: Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks
Time to response
Measured: change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 relative to first dose of study drug
Disease control rate
Measured: Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks
Safety and tolerability, as measured by number of participants with adverse events.
Measured: Measured from first dose of study drug until 30 days after study discontinuation.
Objective response rate
Measured: change in tumour size will be assessed using RECIST measurements. RECIST assessments will be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected 12 weeks,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KRAS Positive Patients With Non-small Cell 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- BIND Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283320
- Sponsor's protocol ID
- BIND-014-007
- Status last verified
- Apr 2016
- First submitted
- 21 Oct 2014
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter, Phase 2 Study to Determine the Safety and Efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as a Second-Line Therapy for Patients With KRAS Mutation Positive or Squamous Cell Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02283320
- Acronym / sponsor ID
- BIND-014-007
- Conditions
- KRAS Positive Patients With Non-small Cell Lung Cancer, Squamous Cell Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- BIND TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 5 Nov 2014 (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.
BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients with v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive or squamous cell non-small cell lung cancer (NSCLC) who have progressed after treatment of one prior platinum-containing chemotherapy regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) | Experimental | Drug: BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males or females at least 18 years of age
- Diagnosis of NSCLC with locally advanced or metastatic disease
- Positive for KRAS mutation or Squamous cell histology
- Previously treated with one platinum-based chemotherapy
- Disease status must be that of measurable and/or evaluable disease
Key exclusion criteria (14 listed)
- Active infection
- Pregnancy or planning to become pregnant
- Breast feeding
- Serious concomitant systemic disorders
- Second primary malignancy
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 |
|---|---|---|
| BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) | Drug | BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) |
Primary outcome
Disease control rate
Time frame: Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks
7 secondary outcomes
Progression-free survival
Time frame: Change in tumor size will be assessed using RECIST measurements. RECIST assessments will be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average of 18 weeks.
Overall survival
Time frame: Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation
Duration of response
Time frame: Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks
Time to response
Time frame: change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 relative to first dose of study drug
Disease control rate
Time frame: Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks
Safety and tolerability, as measured by number of participants with adverse events.
Time frame: Measured from first dose of study drug until 30 days after study discontinuation.
Objective response rate
Time frame: change in tumour size will be assessed using RECIST measurements. RECIST assessments will be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected 12 weeks,
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 18 Apr 2016.
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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.
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) in people with KRAS Positive Patients With Non-small Cell Lung Cancer and Squamous Cell Non-small Cell Lung Cancer, run by BIND Therapeutics at 32 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 12 inclusion and 14 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 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Russia. 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?
Disease control rate (time frame: Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks). 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 18 Apr 2016.