Non-small Cell Lung CancerPhase 2NCT01792479
A Phase 2 Study to Determine the Safety and Efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy to Patients With Non-Small Cell Lung Cancer
A Phase 2 study testing BIND-014 in people with Non-small Cell Lung Cancer, run by BIND Therapeutics at 17 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of BIND-014 in patients with advanced non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- BIND-014
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Apr 2013to 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
- 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
- Prior chemotherapy completed at least 3 weeks prior to study enrollment
Show all 11Show fewer
- 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
Show all 14Show fewer
- 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
17 sites in 2 countries.
17 sites in 2 countries
United States10 sites
Investigative Site #03
Columbus, Ohio, 43221
Investigative Site #02
Fort Meyers, Florida, 33905
Investigative Site #10
Goodyear, Arizona, 85338
Investigative Site #04
Los Angeles, California, 90048
Investigative Site #01
Nashville, Tennessee, 37203
Investigative Site #08
Newnan, Georgia, 30265
Investigative Site #11
Philadelphia, Pennsylvania, 19124
Investigative Site #05
Pittsburgh, Pennsylvania, 15232
Investigative Site #09
Tulsa, Oklahoma, 74133
Investigative Site #07
Zion, Illinois, 60099
Russia7 sites
Investigative Site #15
Chelyabinsk, 454087
Site #17
Krasnodar
Investigative Site #12
Moscow, 115478
Site # 18
Saint Petersburg
Investigative Site #14
Saint-Petersberg, 198255
Investigative Site #13
Saint-Petersberg, 97758
Investigative Site #16
Ufa, 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 Second-line Therapy to Patients With Non-Small Cell Lung Cancer
The purpose of this study is to evaluate the efficacy and safety of BIND-014 in patients with advanced non-small cell lung cancer (NSCLC).
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- BIND-014
- Keywords
- NSCLC, lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIND-014Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm A: BIND-014 every 3 weeks | Experimental | Not described Receives: Drug: BIND-014 |
| Arm B: BIND-014 weekly | Experimental | Not described Receives: Drug: BIND-014 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with either a complete or partial response
To determine the efficacy of BIND-014 as measured by objective response rate (ORR) in patients with Stage III/IV Non-small cell lung cancer (NSCLC) who have failed one prior platinum containing chemotherapy regimen for advanced or metastatic disease.
Measured: Patients will be followed for the duration of treatment, an expected average of 18 weeks
Secondary outcomes (1)
Number of patients who experience adverse events
To assess the safety and tolerability of BIND-014
Measured: Patients will be followed for the duration of treatment, an expected average of 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2016
- Study completionApr 2016
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 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
- NCT01792479
- Sponsor's protocol ID
- BIND-014-005
- Status last verified
- Apr 2016
- First submitted
- 12 Feb 2013
- Last updated
- 15 Apr 2016
- Results posted
- No
Publications
Hrkach J, Von Hoff D, Mukkaram Ali M, Andrianova E, Auer J, Campbell T, De Witt D, Figa M, Figueiredo M, Horhota A, Low S, McDonnell K, Peeke E, Retnarajan B, Sabnis A, Schnipper E, Song JJ, Song YH, Summa J, Tompsett D, Troiano G, Van Geen Hoven T, Wright J, LoRusso P, Kantoff PW, Bander NH, Sweeney C, Farokhzad OC, Langer R, Zale S. Preclinical development and clinical translation of a PSMA-targeted docetaxel nanoparticle with a differentiated pharmacological profile. Sci Transl Med. 2012 Apr 4;4(128):128ra39. doi: 10.1126/scitranslmed.3003651.
PubMed 22491949
Study at a glance
From the registry record, last updated by the sponsor on 15 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 Second-line Therapy to Patients With Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01792479
- Acronym / sponsor ID
- BIND-014-005
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- NSCLC, lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- BIND TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Feb 2013 (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 safety of BIND-014 in patients with advanced non-small cell lung cancer (NSCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: BIND-014 every 3 weeks | Experimental | Drug: BIND-014 |
| Arm B: BIND-014 weekly | Experimental | Drug: BIND-014 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males or females at least 18 years of age
- Diagnosis of NSCLC with locally advanced or metastatic disease
- 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
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 | Drug | Arm A: BIND-014 every 3 weeks, Arm B: BIND-014 weekly |
Primary outcome
Number of patients with either a complete or partial response
Time frame: Patients will be followed for the duration of treatment, an expected average of 18 weeks
To determine the efficacy of BIND-014 as measured by objective response rate (ORR) in patients with Stage III/IV Non-small cell lung cancer (NSCLC) who have failed one prior platinum containing chemotherapy regimen for advanced or metastatic disease.
1 secondary outcome
Number of patients who experience adverse events
Time frame: Patients will be followed for the duration of treatment, an expected average of 18 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 15 Apr 2016.
- Background: PubMed 22491949Hrkach J, Von Hoff D, Mukkaram Ali M, Andrianova E, Auer J, Campbell T, De Witt D, Figa M, Figueiredo M, Horhota A, Low S, McDonnell K, Peeke E, Retnarajan B, Sabnis A, Schnipper E, Song JJ, Song YH, Summa J, Tompsett D, Troiano G, Van Geen Hoven T, Wright J, LoRusso P, Kantoff PW, Bander NH, Sweeney C, Farokhzad OC, Langer R, Zale S. Preclinical development and clinical translation of a PSMA-targeted docetaxel nanoparticle with a differentiated pharmacological profile. Sci Transl Med. 2012 Apr 4;4(128):128ra39. doi: 10.1126/scitranslmed.3003651.
Related trials for Non-small Cell Lung Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Non-small Cell Lung Cancer
Recruiting
Understanding the Feasibility of a Co-designed Pre-radiotherapy Exercise Programme - A Single-arm Study
Lung Cancer
RecruitingPhase 2
Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)
Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Stage I
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.
17 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 in people with Non-small Cell Lung Cancer, run by BIND Therapeutics at 17 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 11 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 15 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 17 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?
Number of patients with either a complete or partial response (time frame: Patients will be followed for the duration of treatment, an expected average of 18 weeks). 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 NCT01792479, 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 15 Apr 2016.