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| Sponsor: | Provectus Pharmaceuticals |
|---|---|
| Information provided by: | Provectus Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00986661 |
Purpose
This open-label study will evaluate the safety, tolerability, pharmacokinetics and effect on tumor growth following a single intralesional injection of PV-10 in subjects with either recurrent hepatocellular carcinoma (HCC) or cancer metastatic to the liver. In each of two planned dose cohorts there will be three subjects. Dose escalation will occur following assessment of safety and tolerability in the first cohort.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Metastatic to the Liver Hepatoma Recurrent |
Drug: PV-10 (10% rose bengal disodium) |
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 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of PV-10 Chemoablation of Cancer Metastatic to the Liver or Recurrent Hepatocellular Carcinoma |
| Estimated Enrollment: | 6 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PV-10 Injection (Intralesional)
Two cohorts of three subjects each will receive a single dose of PV-10 to one Target Lesion.
|
Drug: PV-10 (10% rose bengal disodium)
The initial three subjects will receive a single injection of PV-10 to a single Target Lesion (0.25 mL PV-10 per cc lesion volume, Lv). If none of the initial three subjects experiences a new and persistent Grade 3 non-hematological or any Grade 4 hematological toxicity over a 28-day follow-up interval, an additional three subjects may be enrolled and similarly treated with PV-10 administered at 0.50 mL per cc Lv.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Sharp Memorial Hospital | |
| San Diego, California, United States, 92123 | |
| Study Director: | Eric Wachter, Ph.D. | Provectus Pharmaceuticals |
| Principal Investigator: | Paul M Goldfarb, M.D. | Sharp Clinical Oncology Research |
More Information
| Responsible Party: | Eric Wachter, Ph.D., Study Director, Provectus Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00986661 History of Changes |
| Other Study ID Numbers: | PV-10-LC-01 |
| Study First Received: | September 24, 2009 |
| Last Updated: | March 16, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Liver Neoplasms Carcinoma, Hepatocellular Neoplasms Neoplasms, Second Primary Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Liver Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |