Clinical Trials /

Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of CUDC-907 in Subjects With Advanced/Relapsed Solid Tumors

NCT02307240

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.

Related Conditions:
  • Breast Carcinoma
  • Malignant Solid Tumor
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

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

DrugSynonymsArms
CUDC-907CUDC-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

NameTypeDescriptionInterventions
CUDC-907 - five days on/two days offExperimental60 mg/day CUDC-907, oral administration, five days on/two days off until disease progression or other discontinuation criteria are met.
  • CUDC-907

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

  • TNBC
  • HGSOC
  • NMC

Last Updated

September 3, 2019