Clinical Trials
Current Clinical Trials of NanoPac® (sterile submicron particle 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

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Target:
Prostate Cancer

Now Recruiting

Trial of NanoPac Focal Therapy for Prostate Cancer

This trial evaluates the safety, tolerability, and preliminary efficacy of up to three injections of NanoPac (sterile submicron particle paclitaxel suspension) injected directly into the prostate lesion of men with prostate cancer scheduled for prostatectomy.

Three sites in the U.S. will be participating. If you are over 18 and have been diagnosed with prostate cancer you may qualify for this study.

Study Locations and Contacts:

Henry Ford Health System, Detroit, MI.  Contact: Nicole Adams, 313-916-8862, nadams9@hfhs.org

Additional study locations and contacts will be announced in the future.

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Target:
Lung Cancer

Now Recruiting

Trial of NanoPac Intratumoral Injection in Lung Cancer

This trial evaluates the safety, tolerability, and preliminary efficacy of up to three injections of NanoPac (sterile submicron particle paclitaxel suspension) administered into the lung tumors and lymph nodes of patients with lung cancer. Patients with non-small cell lung cancer or small cell lung cancer are eligible for this study.

Three sites in the U.S. will be participating. If you are over 18 and have been diagnosed with lung cancer you may qualify for this study.

Study Locations and Contacts:

Parkview Cancer Institute, Fort Wayne, IN.  Contact: Jon Lehrman, 260-266-663, jon.lehrman@parkview.com

Additional study locations and contacts will be announced in the future.

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Current Clinical Trials of NanoDoce® (sterile submicron particle docetaxel) for Suspension

Target:
Bladder Cancer

Now Recruiting

Evaluation of NanoDoce in Participants with Urothelial Carcinoma

This clinical trial is studying the administration of NanoDoce as a direct injection to the bladder wall immediately after tumor resection and as an intravesical instillation in an Induction and Maintenance schedule. Patients will be stratified into two treatment groups, Group 1 – non-muscle invasive bladder cancer (NMIBC) and Group 2 – muscle invasive bladder cancer (MIBC). All participants will receive NanoDoce, and will be evaluated for safety and tolerability, as well as the potential effects of NanoDoce on urothelial carcinoma.

Five sites in the U.S. are currently participating. If you are over 18 and have been diagnosed with urothelial carcinoma you may qualify for this study.

Study Locations and Contacts:

BCG Oncology, Phoenix, AZ.  Contact: Debra Mobley, 602-493-6626, debbi@bcgoncology.com
Johns Hopkins Medical Institution, Baltimore, MD.  Contact: Max Kates, 410-955-6100, mkates@jhmi.edu
Carolina Urologic Research Center, Myrtle Beach, SC.  Contact: Jennifer Baiden, 843-449-1010, jbaiden@curcmb.com
Columbia University Herbert Irving Comprehensive Cancer Center, NY, NY.  Contact: Bridget James, 212-304-5543, bb2771@cumc.columbia.edu
UT Health San Antonio, San Antonio, TX. Contact: Karen Nijland, 210-567-8554, NijlandK@uthscsa.edu

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Target:
Renal Cell Carcinoma

Suspended

Trial of NanoDoce Intratumoral Injection in Renal Cell Carcinoma

This trial evaluates the safety, tolerability, and preliminary efficacy of up to two injections of NanoDoce (sterile submicron particle docetaxel suspension) injected directly into tumors of people with renal cell carcinoma that is localized to the kidney.

Three sites in the U.S. will be participating. If you are over 18 and have been diagnosed with renal cell carcinoma you may qualify for this study.

Study Locations and Contacts To Be Announced

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Completed Clinical Trials

Target:
Pancreatic Mucinous-Cystic Neoplasm

Completed

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

This trial evaluated 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. A total of 19 patients were enrolled into the study.

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Target:
Cutaneous Metastases

Completed

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-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.

Three 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.

This trial evaluated 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-melanoma cutaneous metastases. Eligible lesions were determined at baseline by the RECIST definition of measurable tumors (≥ 10mm in its longest diameter). The trial included a dose escalation phase and continued into a dose expansion phase at the 2% strength. A total of 23 patients were enrolled into the study.

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Target:
Peritoneal Cancers

Completed

Trial of NanoPac in Patients with Peritoneal Cancers

This trial evaluated the safety, tolerability, and preliminary efficacy of NanoPac (sterile submicron particle paclitaxel suspension) administered via intraperitoneal (IP) infusion once every 28 days until disease progression or unacceptable toxicity. Patients with refractory malignancies principally confined to the peritoneal cavity were eligible for this study. A total of 22 patients were enrolled into the study.

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Target:
Ovarian Cancer

Completed

Phase II Study of Intraperitoneal NanoPac in Patients With Ovarian Cancer

This trial evaluated the safety, tolerability, and preliminary efficacy of NanoPac (sterile submicron particle paclitaxel suspension) administered via intraperitoneally (IP) instillation at the end of post-cytoreductive surgery, followed by standard of care (SOC) intravenous (IV) chemotherapy. Women with primary and recurrent ovarian cancer scheduled for cytoreductive surgery were eligible for this study. A total of 10 patients were enrolled into the study.

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Target:
Prostate Cancer

Completed

Trial of NanoPac Focal Therapy in Subjects with Prostate Cancer

This trial evaluated the safety, tolerability, and preliminary efficacy of a single injection of NanoPac (sterile submicron particle paclitaxel suspension) administered into the prostate lobe of men with prostate cancer four weeks prior to scheduled prostatectomy. A total of 16 patients were enrolled into the study.

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