A Study of BIND-014 Given to Patients With Advanced or Metastatic Cancer

NCT01300533 | Completed Phase 1 DMC

• 1 other identifier: BIND-014-001
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 6

Brief Summary

The goal of this Phase 1 clinical research study is to find the highest safe dose of BIND-014 that can be given in the treatment of patients with advanced or metastatic cancer.

Conditions

Metastatic Cancer; Cancer; Solid Tumors

Keywords

Cancer; Neoplasms; Solid Tumor; Ovarian Cancer; Lung Cancer; Non-Small Cell Lung Cancer; Pancreatic Cancer; Breast Cancer; Endometrial Cancer; Melanoma; Prostate Cancer; Skin Cancer; Head and Neck Cancer; Solid Malignancies

Outcome Measures

Primary Outcomes (1)

• To assess the dose limiting toxicities (DLTs) of BIND-014 when on day 1 of a 21-day cycle or when given on day 1, 8 and 15 of a 28-day cycle.

  This information will be used to determine the maximum tolerated dose (MTD) of BIND-014 when given weekly or three weeks.

Secondary Outcomes (3)

• To characterize the pharmacokinetics of BIND-014 following an IV infusion.

  First two cycles of BIND-014

• To assess any preliminary evidence of anti-tumor activity observed with BIND-014.

  18 months

• To assess changes in serum tumor markers when appropriate.

  18 months

Interventions

BIND-014 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form. (ICF)
• At least 18 years old.
• Patients with histologically or cytologically confirmed advanced or metastatic cancer for which no standard or curative therapy exists.
• Measurable or evaluable disease per RECIST version 1.1.
• Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 1.
• Life expectancy of greater than 12 weeks.
• Female subjects are eligible to enter and participate in the study if they are of:
• Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any woman who:
• Has had a hysterectomy, or
• Has had a bilateral oophorectomy (ovariectomy), or
• Has had a bilateral tubal ligation, or
• Is post-menopausal (demonstrated total cessation of menses for at least 1 year).
• Childbearing (CB) potential, as long as they have a negative serum pregnancy test at screening and at follow-up, and agrees to one of the following:
• Use an intrauterine device (IUD) with a documented failure rate of less than 1% per year.
• Use double barrier contraception method defined as condom with spermicidal jelly, foam, suppository, or film; OR diaphragm with spermicide; OR male condom and diaphragm.

You may not qualify if:

• Brain metastases or spinal cord compression, unless treatment was completed at least 4 weeks before entry, and stable without steroid treatment for at least 4 weeks.
• Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count (ANC) \< 1.5 x 10\^9/L or platelet count \< 100 x 10\^9/L (cannot be post-transfusion) or hemoglobin \< 9 g/dL (can be post-transfusion).
• Serum bilirubin \> 1.2 times the upper limit of normal (ULN).
• An alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level \> 1.5 x ULN with alkaline phosphatase \> 2.5 x ULN.
• Serum creatinine \> 1.5 x ULN or a creatinine clearance of \< 50 mL/min calculated by Cockcroft-Gault.
• Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac \[including life-threatening arrhythmias\], hepatic, or renal disease).
• Unresolved toxicity ≥ Common Toxicity Criteria (CTC) grade 2 from previous anti-cancer therapy except alopecia (if applicable) unless agreed that the patient can be entered after discussion with the Medical Monitor.
• QTc prolongation defined as a QTc with Framingham correction greater than or equal to 470 ms or a prior history of arrhythmias or significant electrocardiogram (ECG) abnormalities. Certain conditions are acceptable (e.g., controlled atrial fibrillation) if agreed to by Medical Monitor.
• Participation in a study of an investigational agent within 30 days prior to screening.
• Having received treatment for their cancer (including chemotherapy, surgery and/or radiation) within the 30 days prior to screening.
• Pregnant or breast-feeding females.
• Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study (and for up to 26 weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized
• Peritoneal or pleural effusions requiring a tap more frequently than every 14 days.
• Any concurrent condition which, in the Investigator's opinion, makes it undesirable for the subject to participate in this study or which would jeopardize compliance with the protocol.

Sponsors & Collaborators

• BIND Therapeutics: lead

Study Sites (6)

Investigational Site #01

Scottsdale, Arizona, 85258, United States

Location

Investigational Site #02

Greenbrae, California, 94904, United States

Location

Investigational Site #04

Los Angeles, California, 90048, United States

Location

Investigational Site #06

Fort Meyers, Florida, 33905, United States

Location

Investigational Site #03

Detriot, Michigan, 48201, United States

Location

Investigational Site #05

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms; Ovarian Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms; Breast Neoplasms; Endometrial Neoplasms; Melanoma; Prostatic Neoplasms; Skin Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Pancreatic Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Uterine Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: February 21, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: February 1, 2016
• Last Updated: February 9, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share

Locations

US (6)