Advanced Cancer Clinical Trial
— Amblyomin-XOfficial title:
Phase I Study (First in Humans) of the Amblyomin-X in the Treatment of Patients With Advanced Solid Tumors Refractory or Without Indication / Access to Standard Treatment
Verified date | June 2019 |
Source | União Química Farmacêutica Nacional S/A |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Amblyomin-X is an inhibitor of Factor Xa that also acts as an apoptotic agent for tumor cells. In the case of in vitro assays, Amblyomin-X induces tumor cells to death and does not affect the viability of normal cells. When in vivo assays were performed on mice bearing tumors, treatment with Amblyomin-X caused a significant reduction in tumor mass and number of metastases.
Status | Suspended |
Enrollment | 24 |
Est. completion date | May 22, 2022 |
Est. primary completion date | August 20, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Eligible patients must sign the Free and Informed Consent Term (TCLE), - be between 18 and 75 years of age, - present a solid tumor proven by anatomopathological examination at an advanced or metastatic stage and refractory to conventional treatment or without current indication or access to conventional treatment , - have a life expectancy of at least 12 weeks. - presence of measurable disease according to Response Response Criteria in Solid Tumors (RECIST, version 1.1), - medullary, renal and hepatic functions within acceptable limits (defined in protocol), - end of the previous antineoplastic treatment at least 4 weeks (since the last dose of any antineoplastic medication, radiotherapy, or surgical procedure). Exclusion Criteria: - The presence of previously non-irradiated brain metastasis; - Prediction of the use of radiotherapy, surgery, systemic antineoplastic treatment, or any other form of treatment for cancer after inclusion in the study; - Prediction of corticosteroid use, hematopoietic growth factors or inhibitors of bone resorption during the first course of treatment (4 weeks); - Regular use of anticoagulants or known previous coagulation disorder; - Severe comorbidity (at the discretion of the researcher); - Gestational, lactating, pregnant women, or who have not been surgically infertile or menopausal for at least 12 months; - Men and women who refuse to use an adequate contraceptive method during the study period; - Participation of another clinical study in the last 12 months (unless justified by the investigator); - Or inability to comply with study requirements and procedures. |
Country | Name | City | State |
---|---|---|---|
Brazil | União Química Farmacêutica Nacional | Sao Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
União Química Farmacêutica Nacional S/A | Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | grade 4 or non-haematological grade 3 haematological toxicity according to the CTCAE (version 4) | Presence of grade 4 or non-haematological grade 3 haematological toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4) | 2 weeks | |
Secondary | maximum tolerated dose (MTD) and the recommended dose for phase II | This will be based on dose-limiting toxicity of the previous cohort | 2 weeks | |
Secondary | Adverse Events | haematological toxicity | 4 weeks |
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