Advanced Cancer Clinical Trial
Official title:
Phase 1 Trial Evaluating Tolerability and Pharmacokinetics of Chlorogenic Acid for Injection in Patients With Advanced Cancer
| NCT number | NCT02136342 |
| Other study ID # | LYS-I-01 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 1 |
| First received | May 9, 2014 |
| Last updated | October 19, 2014 |
| Start date | May 2014 |
| Verified date | October 2014 |
| Source | Chinese Academy of Medical Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Food and Drug Administration |
| Study type | Interventional |
The purpose of the study is to explore if chlorogenic acid is safe in patients with cancer.
| Status | Terminated |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - advanced cancer with no effective treatment - Karnofsky performance status no less than 70 - adequated organ function - informed consent Exclusion Criteria: - allergic to chlorogenic acid - persistent toxicities from previous treatment (no less than grade 2) |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Chinese Academy of Medical Sciences | Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change in number of red blood cell and level of hemoglobin | within 1 year after the first dose of chlorogenic acid | No | |
| Other | change in the diameters of lymph node metastasis | within 1 year after the first dose of chlorogenic acid | No | |
| Other | change in levels of tumor markers | within 1 year after the first dose of chlorogenic acid | No | |
| Primary | Number of adverse events | within the first 60 days after the first dose of chlorogenic acid | Yes | |
| Secondary | dose-limiting toxicity | within the first 30 days after the first dose of chlorogenic acid | Yes | |
| Secondary | maximum tolerated dose | within the first 30 days after the first dose of chlorogenic acid | Yes | |
| Secondary | Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of chlorogenic acid | within the first 30 days after the first dose of chlorogenic acid | No | |
| Secondary | improvement in cancer-related symptoms and quality of life | within 1 year after the first dose of chlorogenic acid | No |
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