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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01792479
• Other study ID #: BIND-014-005
• Status: Completed
• Phase: Phase 2
• First received: February 12, 2013
• Last updated: April 14, 2016
• Start date: April 2013
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: BIND Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• BIND-014

Locations

Country	Name	City	State
Russian Federation	Investigative Site #15	Chelyabinsk
Russian Federation	Site #17	Krasnodar
Russian Federation	Investigative Site #12	Moscow
Russian Federation	Site # 18	Saint Petersburg
Russian Federation	Investigative Site #13	Saint-Petersberg
Russian Federation	Investigative Site #14	Saint-Petersberg
Russian Federation	Investigative Site #16	Ufa
United States	Investigative Site #03	Columbus	Ohio
United States	Investigative Site #02	Fort Meyers	Florida
United States	Investigative Site #10	Goodyear	Arizona
United States	Investigative Site #04	Los Angeles	California
United States	Investigative Site #01	Nashville	Tennessee
United States	Investigative Site #08	Newnan	Georgia
United States	Investigative Site #11	Philadelphia	Pennsylvania
United States	Investigative Site #05	Pittsburgh	Pennsylvania
United States	Investigative Site #09	Tulsa	Oklahoma
United States	Investigative Site #07	Zion	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
BIND Therapeutics

Countries where clinical trial is conducted

United States,  Russian Federation, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Patients will be followed for the duration of treatment, an expected average of 18 weeks	No
Secondary	Number of patients who experience adverse events	To assess the safety and tolerability of BIND-014	Patients will be followed for the duration of treatment, an expected average of 18 weeks	Yes