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A Clinical Study to Evaluate the Safety and Efficacy of OrienX010 in Unresectable Malignant Melanoma Patients
Study Purpose
This study is being performed to evaluate the safety and efficacy of Dacarbazine and OrienX010 therapy in Untreated Patients With Unresectable Stage IIIb/IIIc or Stage IV(Mla/Mlb) Melanoma. The study will be conducted in about 6 centres in China and total 165 patients will be enrolled. All eligible Patients will be randomized between Dacarbazine and OrienX010 in a 1:2 ratio, so 1/3 (55) patients will receive the Dacarbazine and 2/3 (110) patients will receive the OrienX010. During the treatment phase, the patient will receive OrienX010 administration once biweekly or Dacarbazine once every 3 week until to the end of treatment (EOT). The duration of safety follow-up for adverse events (AEs) and serious adverse events (SAEs) will be to 90 days after the end of treatment. The details please refer to study schema. For patients who have completed the study treatment and no disease progression, follow-up visits will take place every 3 months after the end of treatment visit until the occurrence of disease progression. If disease progression occurred, the investigator will collect the anticancer treatment information and survival of individuals until 80% death event. After the end of study, if patient want to continue receiving the OrienX010 treatment and judged by investigator, sponsor will provide OrienX010 and Dacarbazine for free until disease progression/death or OrienX010 on marketing launch.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 70 Years |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04200040 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
OrienGene Biotechnology Ltd. |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Jun Guo, MD |
Principal Investigator Affiliation | Peking University Cancer Hospital & Institute |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | China |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Melanoma (Skin) |
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.