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Advanced Solid TumorsPhase 1NCT01296581

Safety Study of X-82 in Patients With Advanced Solid Tumors

A Phase 1 study testing X-82 in people with Advanced Solid Tumors, run by Tyrogenex at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the maximum tolerated dose (MTD) of X-82 as a single agent. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
X-82
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited States
Study dates
Feb 2011to Jan 2017
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

  • Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no effective therapy.
  • Expansion Cohort Phase: Histologically or cytologically confirmed recurrent serous or clear cell epithelial ovarian adenocarcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma for which there is no available curative standard therapy, in the investigator's opinion.
  • Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1.
  • Life expectancy of at least 12 weeks.
  • Ability to swallow and retain oral medication.
  • Adequate organ system function.
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  • Male patients willing to use adequate contraceptive measures.
  • Female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures and who have a negative serum or urine pregnancy test within 24 hours prior to initial trial treatment.
  • Patients must have measurable or evaluable disease.
  • Expansion Cohort Phase: Patients with serous histology must have a CA 125 level ≥ 2x ULN within 14 days prior to the start of X-82. Patients with elevated CA 125 levels at baseline are not required to have measurable disease by RECIST criteria. Patients with clear cell histology that do not have an elevated CA 125 level must have measurable disease.
  • Patients must be ≥ 18 years of age.
  • Patients entering this study must be willing to provide tissue from a previous tumor biopsy (if available) for correlative testing. If tissue is not available, a patient will still be eligible for enrollment into the study. For the expansion cohort, patients will also be requested, but not required, to undergo a pre-treatment biopsy.
  • Willingness and ability to comply with trial and follow-up procedures.
  • Ability to understand the nature of this trial and give written informed consent.

Who cannot join

  • Patients currently receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy [with the exception of LHRH agonists for prostate cancer], surgery and/or tumor embolization).
  • Use of an investigational drug within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of X-82. A minimum of 10 days between termination of the investigational drug and administration of X-82 is required. In addition, any drug-related toxicity should have recovered to grade 1 or less.
  • Any major surgery, radiotherapy, or immunotherapy within the last 21 days (limited palliative radiation is allowed ≥2 weeks). Chemotherapy regimens with delayed toxicity within the last 4 weeks (or within the last 6 weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within the last 2 weeks.
  • Patients with a known allergy or delayed hypersensitivity reaction to drugs chemically related to X-82 (sunitinib, sorafenib or pazopanib) or to the active ingredient of X-82.
  • Concomitant use of drugs with a risk of causing prolonged QTc and/or Torsades de Pointes.
  • Concomitant use of herbal medications (i.e. St. John's wort, Kava, ephedra (ma huang), ginko biloba) at least 7 days prior to the first dose of study drug and throughout participation in the trial.
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  • Patients with known CNS metastases, unless metastases are treated and stable and the patients do not require systemic steroids
  • Treatment with therapeutic doses of coumarin-type anticoagulants (maximum daily dose of 1mg allowed for port line patency permitted). Low molecular weight heparin (LMWH) will be allowed.
  • Females who are pregnant or breastfeeding.
  • Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of X-82.
  • Decreased left ventricular function at study entry defined as LVEF <50% by either Echocardiogram or MUGA scan.
  • Patients who have previously experienced myocardial infarction, severe/unstable angina, coronary/peripheral arterial bypass, symptomatic congestive heart failure (New York Heart Association [NYHA] Class 3 or 4), arterial thrombosis, cerebrovascular accident, or transient ischemia, in the 60 days prior to Day 1 of Cycle 1.
  • Patients with inadequately controlled hypertension (defined as BP > 150/100) with or without current antihypertensive medications. Patients with a history of additional risk factors for Torsades de Pointes (e.g. familial long QT syndrome, heart failure, left ventricular hypertrophy, slow heart rate (<45 bpm).
  • Patient with a QTcF interval ≥450 msecs or other significant ECG abnormalities as determined the investigator.
  • A serious active infection at the time of treatment, or another serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  • Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol
  • Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol
  • Patients with a history of intolerance to, or significant toxicity with, VEGFR tyrosine kinase inhibitor(s) (TKI).
  • Patients entering the expansion after the determination of MTD are limited to previous treatment with one anti-VEGFR TKI

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

Other trials in United States

About this study

Official title: Phase I, First in Human, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of X-82 in Patients With Advanced Solid Tumors

The purpose of this study is to determine the maximum tolerated dose (MTD) of X-82 as a single agent.

Being tested
X-82
Keywords
Cancer, Tumors, VEGFR, PDGFR
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • X-82Drug

    Dose escalation starting at 20 mg, oral once or twice a day, 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

Study groups in NCT01296581
Study groupRoleWhat they receive
X-82ExperimentalNot described
Receives: Drug: X-82

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose

    To determine the maximum tolerated dose (MTD) of X-82 as a single agent.

    Measured: 12 months

Secondary outcomes (2)

  1. Preliminary Pharmacokinetics of X-82 given as a single agent

    To characterize the preliminary pharmacokinetics (PK) of X-82 given as a single agent.

    Measured: 12 months

  2. Preliminary biological activity

    To explore the preliminary biological activity and clinical tumor response after treatment with X-82 given as a single agent.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionJan 2014
  4. Study completionJan 2017

Resources

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
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01296581
Sponsor's protocol ID
X82-CLI-101
Status last verified
Feb 2022
First submitted
14 Feb 2011
Last updated
28 Feb 2022
Results posted
No
Data monitoring committee
No

Publications

  • Bendell JC, Patel MR, Moore KN, Chua CC, Arkenau HT, Dukart G, Harrow K, Liang C. Phase I, First-in-Human, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Vorolanib in Patients with Advanced Solid Tumors. Oncologist. 2019 Apr;24(4):455-e121. doi: 10.1634/theoncologist.2018-0740. Epub 2018 Nov 26.

    PubMed 30478190

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing X-82 in people with Advanced Solid Tumors, run by Tyrogenex at 1 site 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 20 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 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Maximum Tolerated Dose (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01296581, which also lists 1 linked publication.

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 28 Feb 2022.

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