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.
Title
- Brief Title: Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of CUDC-907 in Subjects With Advanced/Relapsed Solid Tumors
- 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
Clinical Trial IDs
- ORG STUDY ID:
CUDC-907-102
- NCT ID:
NCT02307240
Conditions
- Triple-Negative Breast Cancer
- High-grade Serous Ovarian Cancer
- Solid Tumors
- NUT Midline Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
CUDC-907 | | CUDC-907 - five days on/two days off |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
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. | |
Eligibility Criteria
Inclusion Criteria:
1. Subjects ≥18 years of age for solid tumor; in the case of midline carcinoma with NUT
rearrangement. subjects may be ≥16 years of age.
2. 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.
3. Measurable or evaluable disease.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
5. Recovery to Grade 1 or baseline of any toxicity due to prior systemic treatments or
radiotherapy (excluding alopecia).
Exclusion Criteria:
1. Systemic anticancer therapy within three weeks of study entry, except for nitrosoureas
or mitomycin C within six weeks.
2. Radiotherapy within one week prior to starting study treatment.
3. Other investigational agent(s) within 21 days prior starting to study treatment.
4. 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.
5. 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 16 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | To determine the safety and tolerability of oral CUDC-907 in subjects with advanced/relapsed solid tumors |
Time Frame: | 21 day cycle |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | To assess the pharmacokinetics (PK) of CUDC-907; Pharmacokinetic parameters will include area under the concentration-time curve (AUC). |
Time Frame: | 21 day cycle |
Safety Issue: | |
Description: | |
Measure: | To evaluate biomarkers of CUDC-907 activity |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Measure: | To assess the preliminary anti-cancer activity of CUDC-907 |
Time Frame: | 24 months |
Safety Issue: | |
Description: | The Investigator will evaluate each subject for response to therapy according to standard response criteria for each individual subject's tumor type |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Curis, Inc. |
Trial Keywords
Last Updated
September 3, 2019