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TumorsPhase 1NCT00728793

A Phase I Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of CUDC-101 in Patients With Advanced Solid Tumors

A Phase 1 study testing CUDC-101 in people with Tumors, run by Curis, Inc. at 2 sites 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

This is a phase I, open-label, dose-escalation study of CUDC-101 in patients with advanced and refractory solid tumors. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2(Her2) and histone deacetylase (HDAC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tumors
What is being tested?
CUDC-101
Type of treatment
Injection or infusion
How many people
25 participants
Where
2 sitesUnited States
Study dates
Aug 2008to Apr 2010
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

  • Subjects with advanced, refractory solid tumors and a histopathologically confirmed diagnosis
  • Subjects must have no further standard of care options or have refused standard therapy
  • Measurable or evaluable disease
  • Age ≥ 18 years
  • ECOG performance < 2
  • Life expectancy ≥ 3 months
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  • If female, neither pregnant or lactating
  • If of child bearing potential, must use adequate birth control
  • Absolute neutrophil count ≥ 1,500/µL; platelets ≥ 100,000/µL;
  • Creatinine ≤ 1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60mL/min/1.73m2
  • Total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2.5x ULN. In subjects with documented liver metastases, the AST/ALT may be ≤ 5x ULN
  • Prothrombin time ≤1.5x ULN, unless receiving therapeutic anticoagulation
  • Serum magnesium and potassium within normal limits (may be supplement to achieve normal values)
  • Subjects with brain metastases are eligible if controlled on a stable dose ≤ 10mg prednisone/day or its equivalent dose of steroids
  • Able to render informed consent and to follow protocol requirements.

Who cannot join

  • Anticancer therapy within 4 weeks of study entry. Prostate cancer subjects on LHRH hormonal therapy may be enrolled and continue on this therapy.
  • Use of investigational agent(s) within 30 days of study entry
  • History of cardiac disease with a New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF), myocardial infarction (MI) or unstable angina in the past 6 months prior to Day 1 of treatment, serious arrhythmias requiring medication for treatment.
  • Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
  • The following are permitted but should be used with caution and other suitable agents used if possible:
  • Subjects receiving concomitant medications metabolized by CYP 3A4 and CYP 2D6
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  • CYP3A4 inducers
  • CYP3A4 inhibitors
  • Warfarin

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • START (South Texas Accelerated Research Therapeutics)

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase I Open-Label, Multiple Dose, Sequential Dose Escalation Study to Investigate the Safety and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced and Refractory Solid Tumors

This is a phase I, open-label, dose-escalation study of CUDC-101 in patients with advanced and refractory solid tumors. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2(Her2) and histone deacetylase (HDAC). The study is designed to establish the safety, including the maximum tolerated dose, the pharmacokinetics, and the anti-tumor activity of CUDC-101.

Conditions
Tumors
Being tested
CUDC-101
Keywords
Advanced Solid Tumors, EGFR, HDAC, Her2, Open-Label, Dose-Escalation
Medical subject headings
Neoplasms

What participants receive

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

  • CUDC-101Drug

    Doses will be given by intravenous infusion over 1 hour on days 1-5 of each treatment cycle. Total treatment cycle duration will be 14 days. Additional treatment cycles will be administered until the subjects withdraws consent, experiences unacceptable toxicity, or if there is documented tumor progression.

What is being measured

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

  1. The highest dose level of CUDC-101 at which <33% of at least 6 or more subjects experiences a dose limiting toxicity.

    The maximum tolerated dose is the highest dose level at which <33% of at least 6 or more subjects experiences a dose limiting toxicity.

    Measured: Study treatment period - approximately 12 months

  2. The number of patients with adverse events.

    The number of patients with adverse events will be assessed to determine the safety and tolerability of CUDC-101.

    Measured: Study treatment period - approximately 12 months

Secondary outcomes (3)

  1. Number of patients that show a response (complete response or partial response) based on RECIST criteria.

    To evaluate the efficacy of CUDC-101 in subjects with advanced and refractory solid tumors, responses based on RECIST criteria will be evaluated.

    Measured: Study treatment period - approximately 12 months

  2. Plasma concentration of CUDC-101 over time from Day 1 through Day 6.

    To assess the pharmacokinetics of CUDC-101 in this patient population, plasma concentration of CUDC-101 will be measured over time from Day 1 through Day 6.

    Measured: Approximately 1 week

  3. Measurement of epidermal growth factor receptor (EGFR) in archival tumor tissue, skin biopsies and tumor biopsies.

    Measurement of EGFR to evaluate pharmacodynamic biomarkers of CUDC-101 activity.

    Measured: Pre-treatment through Day 5 of cycle 1 - approximately 1 week

Timeline

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

  1. First posted6 Aug 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionApr 2010
  4. Study completionApr 2010

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
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00728793
Sponsor's protocol ID
CUDC-101-101
Status last verified
Sep 2015
First submitted
1 Aug 2008
Last updated
22 Feb 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CUDC-101 in people with Tumors, run by Curis, 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 15 inclusion and 9 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 22 Feb 2018. 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?

The highest dose level of CUDC-101 at which <33% of at least 6 or more subjects experiences a dose limiting toxicity. (time frame: Study treatment period - approximately 12 months). 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?

On the ClinicalTrials.gov record for NCT00728793.

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 22 Feb 2018.

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