Triple-Negative Breast CancerPhase 1NCT02307240
Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of CUDC-907 in Subjects With Advanced/Relapsed Solid Tumors
A Phase 1 study testing CUDC-907 in people with Triple-Negative Breast Cancer and High-grade Serous Ovarian Cancer, run by Curis, Inc. at 4 sites in United States.
Trial summary
This is a Phase I, open-label, multi-center trial designed to evaluate the safety, tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with advanced/relapsed solid tumors. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Triple-Negative Breast Cancer, High-grade Serous Ovarian Cancer, Solid Tumors
- What is being tested?
- CUDC-907
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2014to 31 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects ≥18 years of age for solid tumor; in the case of midline carcinoma with NUT rearrangement. subjects may be ≥16 years of age.
- Histopathologically confirmed diagnosis of an advanced solid tumor such as breast cancer or midline carcinoma with NUT rearrangement, that has progressed despite standard therapy, or for which no standard therapy exists. For enrollment in the expansion cohorts, histopathological confirmation of triple-negative breast cancer or high-grade serous ovarian cancer is required.
- Measurable or evaluable disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Recovery to Grade 1 or baseline of any toxicity due to prior systemic treatments or radiotherapy (excluding alopecia).
Who cannot join
- Systemic anticancer therapy within three weeks of study entry, except for nitrosoureas or mitomycin C within six weeks.
- Radiotherapy within one week prior to starting study treatment.
- Other investigational agent(s) within 21 days prior starting to study treatment.
- Symptomatic central nervous system (CNS) involvement or lymphangitic metastasis. Stable or improving CNS disease that is not under active treatment after receipt of adequate therapy is allowed.
- Uncontrolled or severe cardiovascular disease, including myocardial infarction or unstable angina within six 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
UCSF School of Medicine
San Francisco, California, 94143
Florida Cancer Specialists
Sarasota, Florida, 34232
About this study
Official title: Phase I Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, an HDAC and PI3K Inhibitor, in Subjects With Advanced/Relapsed Solid Tumors
This is a Phase I, open-label, multi-center trial designed to evaluate the safety, tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with advanced/relapsed solid tumors.
Read the detailed description
This is a Phase I, open-label, multi-center trial designed to evaluate the safety, tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with advanced/relapsed solid tumors. The following dosing schedule, consisting of 21-day treatment cycles, is being examined:
Five days on/two days off on Days 1 to 5, 8 to 12, and 15 to 19 (5/2 schedule).
- Conditions
- Triple-Negative Breast Cancer, High-grade Serous Ovarian Cancer, Solid Tumors, NUT Midline Carcinoma
- Being tested
- CUDC-907
- Keywords
- TNBC, HGSOC, NMC
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUDC-907Drug
CUDC-907 oral with meals.
| Study group | Role | What they receive |
|---|---|---|
| CUDC-907 - five days on/two days off | Experimental | 60 mg/day CUDC-907, oral administration, five days on/two days off until disease progression or other discontinuation criteria are met. Receives: Drug: CUDC-907 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of oral CUDC-907 in subjects with advanced/relapsed solid tumors
Measured: 21 day cycle
Secondary outcomes (3)
To assess the pharmacokinetics (PK) of CUDC-907; Pharmacokinetic parameters will include area under the concentration-time curve (AUC).
Measured: 21 day cycle
To evaluate biomarkers of CUDC-907 activity
Measured: 24 months
To assess the preliminary anti-cancer activity of CUDC-907
The Investigator will evaluate each subject for response to therapy according to standard response criteria for each individual subject's tumor type
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startNov 2014
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-Negative Breast 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
- 43 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
- NCT02307240
- Sponsor's protocol ID
- CUDC-907-102
- Status last verified
- Aug 2019
- First submitted
- 18 Nov 2014
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, an HDAC and PI3K Inhibitor, in Subjects With Advanced/Relapsed Solid Tumors
- ClinicalTrials.gov ID
- NCT02307240
- Acronym / sponsor ID
- CUDC-907-102
- Conditions
- Triple-Negative Breast Cancer, High-grade Serous Ovarian Cancer, Solid Tumors, NUT Midline Carcinoma
- Keywords
- TNBC, HGSOC, NMC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Curis, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 4 Dec 2014 (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.
This is a Phase I, open-label, multi-center trial designed to evaluate the safety, tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with advanced/relapsed solid tumors.
Detailed description
This is a Phase I, open-label, multi-center trial designed to evaluate the safety, tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with advanced/relapsed solid tumors. The following dosing schedule, consisting of 21-day treatment cycles, is being examined:
Five days on/two days off on Days 1 to 5, 8 to 12, and 15 to 19 (5/2 schedule).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CUDC-907 - five days on/two days off | Experimental | Drug: CUDC-90760 mg/day CUDC-907, oral administration, five days on/two days off until disease progression or other discontinuation criteria are met. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects ≥18 years of age for solid tumor; in the case of midline carcinoma with NUT rearrangement. subjects may be ≥16 years of age.
- Histopathologically confirmed diagnosis of an advanced solid tumor such as breast cancer or midline carcinoma with NUT rearrangement, that has progressed despite standard therapy, or for which no standard therapy exists. For enrollment in the expansion cohorts, histopathological confirmation of triple-negative breast cancer or high-grade serous ovarian cancer is required.
- Measurable or evaluable disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Recovery to Grade 1 or baseline of any toxicity due to prior systemic treatments or radiotherapy (excluding alopecia).
Key exclusion criteria (5 listed)
- Systemic anticancer therapy within three weeks of study entry, except for nitrosoureas or mitomycin C within six weeks.
- Radiotherapy within one week prior to starting study treatment.
- Other investigational agent(s) within 21 days prior starting to study treatment.
- Symptomatic central nervous system (CNS) involvement or lymphangitic metastasis. Stable or improving CNS disease that is not under active treatment after receipt of adequate therapy is allowed.
- Uncontrolled or severe cardiovascular disease, including myocardial infarction or unstable angina within six 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.
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-907CUDC-907 oral with meals. | Drug | CUDC-907 - five days on/two days off |
Primary outcome
To determine the safety and tolerability of oral CUDC-907 in subjects with advanced/relapsed solid tumors
Time frame: 21 day cycle
3 secondary outcomes
To assess the pharmacokinetics (PK) of CUDC-907; Pharmacokinetic parameters will include area under the concentration-time curve (AUC).
Time frame: 21 day cycle
To evaluate biomarkers of CUDC-907 activity
Time frame: 24 months
To assess the preliminary anti-cancer activity of CUDC-907
Time frame: 24 months
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 3 Sep 2019.
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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.
4 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-907 in people with Triple-Negative Breast Cancer and High-grade Serous Ovarian Cancer, run by Curis, Inc. at 4 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 5 inclusion and 5 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 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
To determine the safety and tolerability of oral CUDC-907 in subjects with advanced/relapsed solid tumors (time frame: 21 day cycle). 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 3 Sep 2019.