CarcinomaPhase 1NCT02507544
A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer
A Phase 1 study testing TRX-818 capsules in people with Carcinoma and Advanced Cancer, run by TaiRx, Inc. at 2 sites in United States.
Trial summary
TRX-818 is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by TaiRx, Inc. TRX-818 is a potent anti-cancer agent in numerous human cancer cell lines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Advanced Cancer
- What is being tested?
- TRX-818 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2015to 20 May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tumor eligibility:
- Histologically confirmed advanced malignancies refractory to standard of care therapy, or for whom no standard of care therapy is available.
- Solid tumors must have measurable or evaluable disease as per Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1). Target lesions that have been previously irradiated will not be considered measurable (lesion) unless increase in size is observed following completion of radiation therapy. Leukemia, lymphomas and multiple myeloma must have measurable disease as per response criteria.
- Female or male, 18 years of age or older.
- Eastern Cooperative Oncology Group performance status 0 to 2. Resolution of all acute toxic effects of prior therapy or surgical procedures to grade 1 (except alopecia).
- Adequate organ function as defined by the following criteria:
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- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤3 x upper limit of normal (ULN), or AST and ALT ≤5 x ULN if liver function abnormalities are due to underlying malignancy
- Total serum bilirubin ≤1.5 x ULN (except for patients with documented Gilbert's syndrome)
- Absolute neutrophil count (ANC) >= 1500/µL
- Platelets >= 90,000/µL
- Hemoglobin >= 9.0 g/dL
- Serum creatinine ≤2.0 x ULN
- Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- Patients presenting with any of the following will not be included in the trial:
- Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of starting study treatment.
- Prior high-dose chemotherapy requiring hematopoietic stem cell rescue except for patients with lymphoma or myeloma.
- Current treatment on another clinical trial.
- Brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease unless appropriately treated and neurologically stable for at least 4 weeks.
- Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack; within 6 months prior to starting study treatment for pulmonary embolus. However, upon agreement between the investigator and sponsor, the 6 month post-event-free period for a patient with a pulmonary embolus can be waived if due to advanced cancer. Appropriate treatment with anticoagulants is permitted.
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- Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).
- Current treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg Per oral (PO) daily for deep vein thrombosis prophylaxis is allowed).
- Known human immunodeficiency virus infection.
- Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal, or must agree to the use of effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
- Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, which would make the patient inappropriate for entry into this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
START Midwest
Grand Rapids, Michigan, 49503
South Texas Accelerated Research Therapeutics, LLC (START)
San Antonio, Texas, 78229
About this study
Official title: A Phase I Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer
TRX-818 is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by TaiRx, Inc. TRX-818 is a potent anti-cancer agent in numerous human cancer cell lines. The objectives of this study are to determine the safety profile of TRX-818 including identification of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) and determine the recommended dose and regimen(s) to initiate Phase 2.
- Conditions
- Carcinoma, Advanced Cancer
- Being tested
- TRX-818 capsules
- Keywords
- Advanced Solid Malignancy, Safety and Tolerability, Tumor Response, Hematology, Oncology
- Medical subject headings
- Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRX-818 capsulesDrug
| Study group | Role | What they receive |
|---|---|---|
| TRX-818 | Experimental | Not described Receives: Drug: TRX-818 capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT) of TRX-818
Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0.
Measured: up to 28 days
Maximum tolerated dose (MTD) of TRX-818
The MTD will be defined as the dose level at which at most one of six patients experiences a DLT after 28 days of treatment have occurred, with the next higher dose having at least 2/3 or 2/6 patients experiencing a DLT.
Measured: up to 28 days
Secondary outcomes (3)
Preliminary assessment of anti-tumor activity by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
Measured: up to 112 days
Composite measure of pharmacokinetics (PK) parameters of TRX-818 and its metabolites TRX-818M1 to include AUC(0-last), Cmax, Tmax, T(1/2).
AUC(0-last): area under the plasma concentration versus time curve to the time of the last measurable concentration; Cmax: maximum plasma concentration; Tmax: time to maximum plasma concentration; T(1/2): terminal elimination half-life
Measured: Selected time points during first 28 days
Time to tumor progression (TTP)
Measured: up to 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startSep 2015
- Primary completion29 Apr 2017
- Study completion20 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- TaiRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony W Tolcher, M.D., FRCP(C), Principal investigator, South Texas Accelerated Research Therapeutics, LLC (START)Nehal Lakhani, M.D., Ph.D., Principal investigator, START Midwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507544
- Sponsor's protocol ID
- CVM-001
- Status last verified
- May 2020
- First submitted
- 15 Jul 2015
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT02507544
- Acronym / sponsor ID
- CVM-001
- Conditions
- Carcinoma, Advanced Cancer
- Keywords
- Advanced Solid Malignancy, Safety and Tolerability, Tumor Response, Hematology, Oncology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- TaiRx, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- 29 Apr 2017 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 24 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TRX-818 is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by TaiRx, Inc. TRX-818 is a potent anti-cancer agent in numerous human cancer cell lines. The objectives of this study are to determine the safety profile of TRX-818 including identification of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) and determine the recommended dose and regimen(s) to initiate Phase 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRX-818 | Experimental | Drug: TRX-818 capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Tumor eligibility:
- Histologically confirmed advanced malignancies refractory to standard of care therapy, or for whom no standard of care therapy is available.
- Solid tumors must have measurable or evaluable disease as per Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1). Target lesions that have been previously irradiated will not be considered measurable (lesion) unless increase in size is observed following completion of radiation therapy. Leukemia, lymphomas and multiple myeloma must have measurable disease as per response criteria.
- Female or male, 18 years of age or older.
- Eastern Cooperative Oncology Group performance status 0 to 2. Resolution of all acute toxic effects of prior therapy or surgical procedures to grade 1 (except alopecia).
Key exclusion criteria (11 listed)
- Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of starting study treatment.
- Prior high-dose chemotherapy requiring hematopoietic stem cell rescue except for patients with lymphoma or myeloma.
- Current treatment on another clinical trial.
- Brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease unless appropriately treated and neurologically stable for at least 4 weeks.
- Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack; within 6 months prior to starting study treatment for pulmonary embolus. However, upon agreement between the investigator and sponsor, the 6 month post-event-free period for a patient with a pulmonary embolus can be waived if due to advanced cancer. Appropriate treatment with anticoagulants is permitted.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRX-818 capsules | Drug | TRX-818 |
Primary outcome
Dose limiting toxicity (DLT) of TRX-818
Time frame: up to 28 days
Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0.
Maximum tolerated dose (MTD) of TRX-818
Time frame: up to 28 days
The MTD will be defined as the dose level at which at most one of six patients experiences a DLT after 28 days of treatment have occurred, with the next higher dose having at least 2/3 or 2/6 patients experiencing a DLT.
3 secondary outcomes
Preliminary assessment of anti-tumor activity by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
Time frame: up to 112 days
Composite measure of pharmacokinetics (PK) parameters of TRX-818 and its metabolites TRX-818M1 to include AUC(0-last), Cmax, Tmax, T(1/2).
Time frame: Selected time points during first 28 days
Time to tumor progression (TTP)
Time frame: up to 112 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony W Tolcher, M.D., FRCP(C) principal investigator
South Texas Accelerated Research Therapeutics, LLC (START)
Nehal Lakhani, M.D., Ph.D. principal investigator
START Midwest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRX-818 capsules in people with Carcinoma and Advanced Cancer, run by TaiRx, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) of TRX-818 (time frame: up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.