Advanced Cancer
Conditions
Keywords
Phase I,
Brief summary
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.
Detailed description
This trial will be the first clinical study in humans with the product, which until then has been studied only in experimental models. Given the current epidemiological impact of cancer and the need to improve its systemic treatment, making it available to a larger portion of the Brazilian population, it is proposed to conduct the first Amblyomin-X study in cancer patients, more specifically those with advanced solid tumors For which there is no contraindicated or inaccessible therapeutic option established as the standard at the time of inclusion in the study.
Interventions
BIOLOGICALAmblyomin-X
Intravenous drug administration, with different doses in each cohort
Sponsors
Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME
União Química Farmacêutica Nacional S/A
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Study with dose escalation regime, done according to the classic scheme known as 3 + 3
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| grade 4 or non-haematological grade 3 haematological toxicity according to the CTCAE (version 4) | 2 weeks | Presence of grade 4 or non-haematological grade 3 haematological toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| maximum tolerated dose (MTD) and the recommended dose for phase II | 2 weeks | This will be based on dose-limiting toxicity of the previous cohort |
| Adverse Events | 4 weeks | haematological toxicity |
Countries
Brazil
Outcome results
None listed