CancerPhase 1NCT01702285
Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of Orally Administered CUDC-101 in Cancer Patients
A Phase 1 study testing CUDC-101 in people with Cancer, run by Curis, Inc. at 2 sites in United States.
Trial summary
The main purpose of this study is to determine the safety and tolerability of orally administered CUDC-101 in cancer patients, and to determine a dose for further testing. This study will also determine how well CUDC-101 is absorbed into the blood after being given orally, assess CUDC-101 blood levels and what happens… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- CUDC-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to Dec 2012
- 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 a histopathologically confirmed diagnosis of advanced solid tumor.
- Subjects must have no further standard of care options.
- Measurable or non-measurable disease
- Age ≥ 18 years
- ECOG performance status ≤ 2
- Life expectancy ≥ 3 months
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- Women of child bearing potential must have a negative serum pregnancy test.
- Absolute neutrophil count ≥ 1,500/µL; platelets ≥ 100,000/µL; creatinine ≤ 1.5x upper limit of normal (ULN); total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2.5x ULN. For subjects with documented liver metastases, the AST/ALT may be ≤ 5x ULN
- Serum magnesium and potassium within normal limits (may be supplemented to achieve normal values).
- Subjects with brain metastases are eligible if controlled on a stable dose of ≤ 10mg prednisone/day or its equivalent dose of steroids.
- Men and women of child bearing potential must agree to use adequate birth control throughout their participation in the study and for 60 days following the last study treatment.
- Able to provide written informed consent and to follow protocol requirements.
Who cannot join
- Systemic anticancer therapy within 28 days prior to study treatment. Subjects with prostate cancer on LHRH hormonal therapy may be enrolled and continue on this therapy.
- Use of any investigational agent(s) within 21 days prior to study treatment.
- Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.
- Subjects receiving moderate or strong CYP3A4 or CYP2D6 inhibitors within 7 days prior to study treatment (See Appendix C for examples).
- Serious infection requiring systemic antibiotic therapy within 14 days prior to study treatment.
- Known gastrointestinal condition that would interfere with swallowing or the oral absorption or tolerance of CUDC-101.
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- Ongoing diarrhea of any grade (per NCI CTCAE v4.03).
- Uncontrolled or severe cardiovascular disease, including myocardial infarct or unstable angina within 6 months prior to study treatment, New York Heart Association (NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease, or cardiac amyloidosis.
- Unstable or clinically significant concurrent medical condition that would, in the opinion of the Investigator, jeopardize the safety of a subject and/or their compliance with the protocol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Karmanos Cancer Institute
Detroit, Michigan, 48201
Southern Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
About this study
Official title: A Phase I Open Label, Multicenter, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Orally Administered CUDC-101 in Subjects With Advanced and Refractory Solid Tumors
The main purpose of this study is to determine the safety and tolerability of orally administered CUDC-101 in cancer patients, and to determine a dose for further testing. This study will also determine how well CUDC-101 is absorbed into the blood after being given orally, assess CUDC-101 blood levels and what happens to the study drug in the body, and study how the body reacts to the study drug and what effects it has on tumors. CUDC-101 has been administered to cancer patients as an intravenous (IV) infusion in other research studies, but has not been studied when given orally.
- Conditions
- Cancer
- 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
200-500 mg CUDC-101, orally administered, twice daily, in continuous 21 day cycles until disease progression or other discontinuation criteria are met.
| Study group | Role | What they receive |
|---|---|---|
| CUDC-101 | Experimental | 200-500 mg CUDC-101, orally administered, twice daily, in continuous 21 day cycles until disease progression or other discontinuation criteria are met. Receives: Drug: CUDC-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose of oral CUDC-101 in subjects with advanced and refractory solid tumors
The highest dose level studied at which fewer than 2 out of 6 subjects (< 33%) experience a dose limiting toxicity (DLT).
Measured: 21 days (1 cycle of study treatment)
Assess the bioavailability (BA) of orally administered CUDC-101
Comparison of area under the plasma concentration time curve (AUC) following intravenous and oral administrations.
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose on the first and second day of study drug dosing.
Assess the pharmacokinetics (PK) of orally administered CUDC-101
Pharmacokinetic parameters will include AUC, maximum plasma concentration (Cmax),half-life (T1/2), clearance (Cl) and volume of distribution (Vd).
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose on the ninth day of study drug dosing
Secondary outcomes (3)
Assess the safety and tolerability of continuous orally administered CUDC-101
Number of participants with adverse events assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE, v4.0).
Measured: 18 months
Evaluate biomarkers of CUDC-101 activity
Pre- and post-dose changes in acetylated histone H3 protein levels in peripheral blood mononuclear cells (PBMCs), as well as skin and tumor biopsy samples (where available).
Measured: Day 1 and Day 7 of Cycle 1 dosing.
Assess preliminary anti-cancer activity
Occurrences of complete response, partial response, stable disease and progressive disease as determined by the Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702285
- Sponsor's protocol ID
- CUDC-101-105
- Status last verified
- Feb 2018
- First submitted
- 25 Sep 2012
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open Label, Multicenter, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Orally Administered CUDC-101 in Subjects With Advanced and Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT01702285
- Acronym / sponsor ID
- CUDC-101-105
- Conditions
- Cancer
- Keywords
- Advanced Solid Tumors, EGFR, HDAC, Her2, Open-Label, Dose-Escalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Curis, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Oct 2012 (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.
The main purpose of this study is to determine the safety and tolerability of orally administered CUDC-101 in cancer patients, and to determine a dose for further testing. This study will also determine how well CUDC-101 is absorbed into the blood after being given orally, assess CUDC-101 blood levels and what happens to the study drug in the body, and study how the body reacts to the study drug and what effects it has on tumors. CUDC-101 has been administered to cancer patients as an intravenous (IV) infusion in other research studies, but has not been studied when given orally.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CUDC-101 | Experimental | Drug: CUDC-101200-500 mg CUDC-101, orally administered, twice daily, in continuous 21 day cycles until disease progression or other discontinuation criteria are met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects with a histopathologically confirmed diagnosis of advanced solid tumor.
- Subjects must have no further standard of care options.
- Measurable or non-measurable disease
- Age ≥ 18 years
- ECOG performance status ≤ 2
Key exclusion criteria (9 listed)
- Systemic anticancer therapy within 28 days prior to study treatment. Subjects with prostate cancer on LHRH hormonal therapy may be enrolled and continue on this therapy.
- Use of any investigational agent(s) within 21 days prior to study treatment.
- Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.
- Subjects receiving moderate or strong CYP3A4 or CYP2D6 inhibitors within 7 days prior to study treatment (See Appendix C for examples).
- Serious infection requiring systemic antibiotic therapy within 14 days prior to study treatment.
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 |
|---|---|---|
| CUDC-101200-500 mg CUDC-101, orally administered, twice daily, in continuous 21 day cycles until disease progression or other discontinuation criteria are met. | Drug | CUDC-101 |
Primary outcome
Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose of oral CUDC-101 in subjects with advanced and refractory solid tumors
Time frame: 21 days (1 cycle of study treatment)
The highest dose level studied at which fewer than 2 out of 6 subjects (< 33%) experience a dose limiting toxicity (DLT).
Assess the bioavailability (BA) of orally administered CUDC-101
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose on the first and second day of study drug dosing.
Comparison of area under the plasma concentration time curve (AUC) following intravenous and oral administrations.
Assess the pharmacokinetics (PK) of orally administered CUDC-101
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose on the ninth day of study drug dosing
Pharmacokinetic parameters will include AUC, maximum plasma concentration (Cmax),half-life (T1/2), clearance (Cl) and volume of distribution (Vd).
3 secondary outcomes
Assess the safety and tolerability of continuous orally administered CUDC-101
Time frame: 18 months
Evaluate biomarkers of CUDC-101 activity
Time frame: Day 1 and Day 7 of Cycle 1 dosing.
Assess preliminary anti-cancer activity
Time frame: 18 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 CUDC-101 in people with Cancer, 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 12 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: stopped early, as of the sponsor's last update on 12 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 was stopped early. Results are not available in the source record.
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?
Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose of oral CUDC-101 in subjects with advanced and refractory solid tumors (time frame: 21 days (1 cycle of study treatment)). The study lists 3 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 12 Feb 2018.