Clinical trial NCT03120130: Study of Amblyomin-X in Advanced Solid Tumor
Official 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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Advanced Cancer
Keywords: Phase I,
Lead sponsor: União Química Farmacêutica Nacional S/A
Sponsor class: INDUSTRY
Collaborators: name: Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME
First posted: 2017-04-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Study with dose escalation regime, done according to the classic scheme known as "3 + 3"
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: grade 4 or non-haematological grade 3 haematological toxicity according to the CTCAE (version 4)
timeFrame: 2 weeks
Secondary outcomes:
measure: maximum tolerated dose (MTD) and the recommended dose for phase II
timeFrame: 2 weeks
measure: Adverse Events
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: União Química Farmacêutica Nacional
state: SP
Study officials:
affiliation: União Quimica
name: Paula F Santos
role: STUDY_DIRECTOR
References: