Clinical trial · Interventional
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
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
NCT01792479CI-TRIAL-00021781completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIND-014 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: BIND-014 every 3 weeks
- interventionNames
- Drug: BIND-014
- type
- EXPERIMENTAL
- label
- Arm B: BIND-014 weekly
- interventionNames
- Drug: BIND-014
Primary outcomes (1)
- measure
- Number of patients with either a complete or partial response
- timeFrame
- Patients will be followed for the duration of treatment, an expected average of 18 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * Active infection * Pregnancy or planning to become pregnant * Breast feeding * Serious concomitant systemic disorders * Second primary malignancy * Patients who are symptomatic from brain metastasis * 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
References
Publications (1)
- BACKGROUNDHrkach 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. PMID 22491949