- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03120130
Study of Amblyomin-X in Advanced Solid Tumor (Amblyomin-X)
October 11, 2019 updated by: União Química Farmacêutica Nacional S/A
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
-
Sao Paulo, SP, Brazil, 05676-120
- União Química Farmacêutica Nacional
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
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.
|
Intravenous drug administration, with different doses in each cohort
|
Experimental: Cohort 2
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
|
Intravenous drug administration, with different doses in each cohort
|
Experimental: Cohort 3
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
|
Intravenous drug administration, with different doses in each cohort
|
Experimental: Cohort 4
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
|
Intravenous drug administration, with different doses in each cohort
|
Experimental: Cohort 5
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
|
Intravenous drug administration, with different doses in each cohort
|
Experimental: Cohort 6
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.
|
Intravenous drug administration, with different doses in each cohort
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
grade 4 or non-haematological grade 3 haematological toxicity according to the CTCAE (version 4)
Time Frame: 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)
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
maximum tolerated dose (MTD) and the recommended dose for phase II
Time Frame: 2 weeks
|
This will be based on dose-limiting toxicity of the previous cohort
|
2 weeks
|
Adverse Events
Time Frame: 4 weeks
|
haematological toxicity
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Paula F Santos, União Quimica
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 15, 2021
Primary Completion (Anticipated)
August 20, 2021
Study Completion (Anticipated)
May 22, 2022
Study Registration Dates
First Submitted
March 29, 2017
First Submitted That Met QC Criteria
April 18, 2017
First Posted (Actual)
April 19, 2017
Study Record Updates
Last Update Posted (Actual)
October 14, 2019
Last Update Submitted That Met QC Criteria
October 11, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PGUQ002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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