Study of Amblyomin-X in Advanced Solid Tumor

NCT03120130 | Suspended Phase 1 DMC

• 1 other identifier: PGUQ002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer

Keywords

Phase I,

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• maximum tolerated dose (MTD) and the recommended dose for phase II

  2 weeks

• Adverse Events

  4 weeks

Study Arms (6)

Cohort 1

EXPERIMENTAL

This cohort will include 3 patients with the first calculated dose of Amblyomin-X drug. The patient will receive the intravenous drug. If no Dose-limiting toxicity (DLT) in this group the study continues including the next cohort. However, if If only one patient in a given cohort develops DLT, three more patients will be included at that dose level, up to a maximum total of six patients per dose level. If two or more of the three patients of a certain dose level develop DLT, this dose level is considered very toxic, and the study does not proceed. If this occurs at the first dose level, the study will be finalized. If only one in six patients at a dose level develops DLTs, escalation proceeds until Tolerated Maximum Dose.

Biological: Amblyomin-X

Cohort 2

EXPERIMENTAL

This cohort will include 3 patients with the second calculated dose of Amblyomin-X drug. The patient will receive the intravenous drug. If no Dose-limiting toxicity in this group the study continues including the next cohort

Biological: Amblyomin-X

Cohort 3

EXPERIMENTAL

This cohort will include 3 patients with the third calculated dose of Amblyomin-X drug. The patient will receive the intravenous drug. If no Dose-limiting toxicity in this group the study continues including the next cohort

Biological: Amblyomin-X

Cohort 4

EXPERIMENTAL

This cohort will include 3 patients with the fourth calculated dose of Amblyomin-X drug. The patient will receive the intravenous drug. If no Dose-limiting toxicity in this group the study continues including the next cohort

Biological: Amblyomin-X

Cohort 5

EXPERIMENTAL

This cohort will include 3 patients with the fifth calculated dose of Amblyomin-X drug. The patient will receive the intravenous drug. If no Dose-limiting toxicity in this group the study continues including the next cohort

Biological: Amblyomin-X

Cohort 6

EXPERIMENTAL

This cohort will include 3 patients with the sixth calculated dose of Amblyomin-X drug, the last dose calculated. The patient will receive the intravenous drug.

Biological: Amblyomin-X

Interventions

Amblyomin-X BIOLOGICAL

Intravenous drug administration, with different doses in each cohort

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• The presence of previously non-irradiated brain metastasis;
• 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.

Sponsors & Collaborators

• União Química Farmacêutica Nacional S/A: lead
• Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME: collaborator

Study Sites (1)

União Química Farmacêutica Nacional

São Paulo, São Paulo, 05676-120, Brazil

Location

MeSH Terms

Interventions

Amblyomin-X protein, Amblyomma cajennense

Study Officials

• Paula F Santos

  União Quimica

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study with dose escalation regime, done according to the classic scheme known as "3 + 3"

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 19, 2017
• Study Start: February 15, 2021
• Primary Completion: August 20, 2021
• Study Completion: May 22, 2022
• Last Updated: October 14, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)