A Phase 1 study of the body and tumour effects of CUDC-101 in HER2 positive breast cancer patients

• Conditions: HER2 positive breast cancer; MedDRA version: 14.1Level: LLTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003064-47-GB
• Lead Sponsor: Curis, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-30
• Last Update Posted: 14 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Female subjects with invasive breast cancer.
2. Tumour must be confined to either the breast or to the breast and ipsilateral axilla, measuring >15mm.
3. HER2-positive defined using FISH/CISH and/or DAKO +++ positivity.
4. Histologically confirmed through either core needle biopsy or an incisional biopsy. Excisional biopsy will not be allowed.
5. Measurable or evaluable disease amenable to repeated biopsies.
6. Age =18 years.
7. ECOG performance status 0 or 1.
8. Life expectancy =3 months.
9. Neither pregnant nor lactating.
10. If of childbearing potential must agree to use adequate birth control for the duration of the study and for 30 days following the last dose of study drug. Negative pregnancy test within 7 days prior to registration.
11. Absolute neutrophil count =1500/µL; platelets =100,000/µL; serum creatinine = ULN; total bilirubin =1.5x ULN; AST/ALT =2.5x ULN; serum magnesium and potassium within normal limits (may use supplements to achieve normal values).
12. Subjects must agree to two biopsies following their diagnostic biopsy – a pre- and a post- therapy biopsy.
13. Able to provide informed consent and to follow protocol requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Prior or concurrent systemic anticancer therapy.
2. Prior w thdrawal from hormone replacement therapy = 3 months previously.
3. Prior or concurrent ipsilateral radiation therapy for invasive or non-invasive breast cancer.
4. Evidence of distant metastatic disease (beyond adjacent nodes).
5. Inflammatory breast cancer.
6. Use of investigational agent(s) within 14 days prior to the first dose of study drug.
7. History of cardiac disease with a New York Heart Association Class II or greater congestive heart failure, myocardial infarction or unstable angina in the past 6 months prior to Day 1 of treatment, or serious arrhythmias requiring medication for treatment.
8. Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C.
9. Subjects with prolonged QTc interval >450 seconds.
10. Known history of GI bleeding, ulceration, or perforation.
11. Subjects receiving regular warfarin.
12. Known history of stroke or cerebrovascular accident within the past 6 months.
13. Any uncontrolled condition which in the opinion of the Investigator could affect the subject’s participation in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified