Clinical Programs

Our Clinical Programs
NanOlogy has progressed an extensive clinical program to evaluate local delivery of sterile and topical forms of our patented submicron particle production technology platform. Developed under FDA’s streamlined 505(b)2 regulatory pathway, the program includes five clinical trials underway on NanoPac® (sterile submicron particle paclitaxel suspension).  In late 2018, NanOlogy will begin a clinical trial of NanoDoce® (sterile submicron particle docetaxel suspension) in the treatment of bladder cancer. An inhaled version of NanoPac is undergoing IND-enabling preclinical studies in NSCLC.

Our clinical trials target the following diseases:

Pancreatic Cancer

Pancreatic Cyst

Prostate Cancer

Ovarian Cancer

Cutaneous Metastases

Current Clinical Trials of NanoPac® (sterile nanoparticle paclitaxel) for Suspension

Target:
Pancreatic Cancer

Now Recruiting

Trial of NanoPac® in Patients With Locally Advanced Pancreatic Adenocarcinoma

This trial evaluates the safety, tolerability, and preliminary efficacy of NanoPac® (sterile submicron particle paclitaxel suspension) injected intratumorally via endoscope-guided fine needle injection into patients with locally advanced pancreatic adenocarcinoma.

Four sites in the U.S. are currently participating. If you are over 18 and have been diagnosed with locally advanced pancreatic adenocarcinoma you may qualify for this study.

Study Locations and Contacts:

Baylor College of Medicine, Houston, TX.  Contact: Nichole Stewart, 713-798-0960, nlstewar@bcm.edu
Parkview Cancer Institute, Fort Wayne, IN.  Contact: Christina Zelt, 260-266-4153, christina.zelt@parkview.com
Cedars Sinai Medical Center, Los Angeles, CA.  Contact: Liliana Claudia Bancila, 310-423-3872, liliana.bancila@cshs.org
Texas Tech University HSC, El Paso, TX.  Contact: Nancy Casner, 915-525-5822, nancy.casner@utthsc.edu

More Trial Information

Target:
Pancreatic Mucinous-Cystic Neoplasm

Now Recruiting

Trial Evaluating Escalating Doses and the Safety of Intracystic Injection of NanoPac in Subjects With Mucinous Cystic Pancreatic Neoplasms

This trial evaluates the safety, tolerability, and preliminary efficacy of NanoPac® (sterile submicron particle paclitaxel suspension) injected intracystically into patients with mucinous pancreatic cysts via endoscope-guided fine needle injection following aspiration of the cyst during the same procedure.

Three sites in the U.S. are currently participating.  If you are over 18 and have a mucinous pancreatic cyst you may qualify for this study.

Study Locations and Contacts:

Baylor College of Medicine, Houston, TX.  Contact:  Aziz Tabash, 713-798-5765, abdalaziz.tabash@bcm.edu
University of Chicago Medicine, Chicago, IL.  Contact: Kianoush Donboli, 773-926-8490, kdonboli@medicine.bsd.uchicago.edu
Parkview Cancer Institute, Fort Wayne, IN.  Contact: Christina Zelt, 260-266-4153, christina.zelt@parkview.com

More Trial Information

Target:
Prostate Cancer

Enrollment Closed

Trial of NanoPac® Focal Therapy in Subjects with Prostate Cancer

This trial evaluates the safety, tolerability, and preliminary efficacy of NanoPac® (sterile submicron particle paclitaxel suspension) injected intratumorally via transrectal ultrasound-guided fine needle injection into patients with prostate cancer scheduled for radical prostatectomy.

One site in the U.S. is currently participating. If you are over 18 and have been diagnosed with prostate cancer you may qualify for this study.

Study Location and Contacts:

University of Southern California, Los Angeles, CA.  Contact:  Ileana Aldana, 323-865-0702ileana.aldana@med.usc.edu

More Trial Information

Target:
Ovarian Cancer

Under Review

Phase II Study of Intraperitoneal NanoPac® in Patients With Ovarian Cancer

This trial evaluates the safety, tolerability, and preliminary efficacy of NanoPac® (sterile submicron particle paclitaxel suspension) administered intraperitoneally (IP) at the end of post-cytoreductive surgery, followed by standard of care (SOC) intravenous (IV) chemotherapy, in women with ovarian cancer.

Eight sites in the U.S. are participating.  If you are over 18 and have been diagnosed with epithelial ovarian cancer you may qualify for this study.

For more information regarding this trial, please email NANOPAC201601@usbiotest.com or call 1-805-595-1300.

Study Locations:

University of Oklahoma, Oklahoma City, OK.  
SUNY Downstate, Brooklyn, NY. 
Women & Infants Hospital of Rhode Island, Providence, RI. 
University of Texas Southwestern, Dallas, TX. 
University of Chicago, Chicago, IL. 
Greater Baltimore Medical Center, Baltimore, MD.
Magee-Women’s Hospital of UPMC, Pittsburg, PA.  
University of Minnesota, Minneapolis, MN.

More Trial Information

Current Clinical Trials of SOR007 (nanoparticle paclitaxel) Ointment

Target:
Cutaneous Metastases

Now Recruiting

Study of Topical SOR007 Ointment for Cutaneous Metastases

This trial evaluates the safety, tolerability and preliminary efficacy of three concentrations of submicron particle paclitaxel anhydrous ointment (0.15%, 1.0%, and 2.0%) identified as SOR007 applied topically to patients with non-ulcerated, non-melanoma cutaneous metastases. Eligible lesions will be determined at baseline by the RECIST definition of measurable tumors (≥ 10mm in its longest diameter). The trial will include a dose escalation phase and a dose expansion phase.

Four sites in the U.S. are participating. If you are over 18 and have cutaneous metastasis originating from non-melanoma metastatic cancer you may qualify for this study.

Study Locations and Contacts:

University of Southern California, Los Angeles, CA.  Contact:  Julie E Lang, 323-422-8140 julie.lang@med.usc.edu
Sarcoma Oncology Center, Santa Monica, CA.  Contact: Victoria Chua, 310-201-6685, vchua@sarcomaoncology.com
Memorial Sloan Kettering Cancer Center, New York, NY.  Contact: Brian Kunzel, 646-888-4452, kunzelb@mskcc.org
Houston Methodist, Houston, TX.  Contact: Toniva Boone, 713-441-0686, tdboone@houstonmethodist.org

More Trial Information

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