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| Sponsor: | BIND Biosciences |
|---|---|
| Information provided by: | BIND Biosciences |
| ClinicalTrials.gov Identifier: | NCT01300533 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Cancer Cancer Solid Tumors |
Drug: BIND-014 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I, Open Label , Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation Study of BIND-014 Given by IV Infusion to Patients With Advanced or Metastatic Cancer |
| Study Start Date: | January 2011 |
The study is designed to explore the safety, tolerability, pharmacokinetics and pharmacodynamics of BIND-014 and define a recommended Phase 2 dose of BIND-014.
All cycles of therapy will consist of the patient taking BIND-014 intravenously once every three weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
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:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| TGen Clinical Research Services at Scottsdale Healthcare | Recruiting |
| Scottsdale, Arizona, United States, 85258 | |
| Contact: Joyce Schaffer, R.N., M.S.N., O.C.N.. 480-323-1339 joschaffer@shc.org | |
| Principal Investigator: Daniel D. Von Hoff, M.D., F.A.C.P. | |
| United States, California | |
| Marin Cancer Care | Recruiting |
| Greenbrae, California, United States, 94904 | |
| Contact: Jaime Chang, B.S., C.C.R.P. 415-925-5040 jchang@marincancercare.com | |
| Principal Investigator: Peter D Eisenberg, M.D., F.A.C.P. | |
| United States, Michigan | |
| Karmanos Cancer Institute | Recruiting |
| Detriot, Michigan, United States, 48201 | |
| Contact: Karen Forman 313-576-8365 formank@karmanos.org | |
| Principal Investigator: Patricia LoRusso, D.O. | |
| Principal Investigator: | Daniel D. Von Hoff, M.D., F.A.C.P. | TGen Clinical Research Services at Scottsdale Healthcare |
| Principal Investigator: | Peter D. Eisenberg, M.D., F.A.C.P. | Marin Cancer Care |
| Principal Investigator: | Patricia LoRusso, D.O. | Karmanos Cancer Institute |
More Information
| Responsible Party: | Edward Schnipper, M.D., BIND Biosciences |
| ClinicalTrials.gov Identifier: | NCT01300533 History of Changes |
| Other Study ID Numbers: | BIND-014-001 |
| Study First Received: | February 17, 2011 |
| Last Updated: | June 23, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
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 |
|
Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Neoplastic Processes Pathologic Processes |