Phase II, open label clinical study to investigate anti-tumour effect and tolerability of the PARP inhibitor 2X-121 in patients with metastatic breast cancer selected by the 2X-121 DRP®.
- Conditions
- Metastatic Breast CancerMedDRA version: 20.0Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-003508-39-DK
- Lead Sponsor
- Oncology Venture Aps
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 26
1. Signed informed consent form.
2. Age 18 years or older.
3. Histologically or cytological documented mBC (independent of hormone receptor, HER2 status and BRCA1 or 2 status) relapsed on 2 or more different prior therapies.
4. Measurable disease by CT scan or MRI.
5. With a drug response prediction (DRP®) for 2X-121 with an outcome measured as being in the upper 10% likelihood of response.
6. Prior chemotherapy or hormone therapy for metastatic breast cancer is allowed.
7. Performance status of ECOG = 1.
8. Recovered to Grade <1 or baseline from prior surgery or from acute toxicities of prior radiotherapy, or from treatment with cytotoxic, hormonal or biologic agents.
9. = 2 weeks must have elapsed since any prior surgery or therapy with G-CSF and GM-CSF.
10. Patients with intracranial disease must be on stable or decreased level of steroid therapy (e.g. dexamethasone) for at least 7 days prior to baseline MRI. Non-enzymatic inducing anti-epileptic drugs are allowed.
11. Adequate conditions as evidenced by the following clinical laboratory values:
a. Absolute neutrophils count (ANC) = 1.5 x 109/L
b. Haemoglobin > 4.6 mmol/L
c. Platelets = 100 x 109 /L
d. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 x ULN*
e. Serum bilirubin = 1.5 ULN
f. Alkaline phosphatase = 3 x ULN*
g. Creatinine = 1.5 ULN
h. Blood urea within normal limits
12. Life expectancy equal or longer than 3 months.
13. Sexually active females of child-producing potential must use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception) for the study duration and at least six months afterwards.
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 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1. Concurrent chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period.
2. Previous treatment with PARP inhibitors.
3. Other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study.
4. Any active infection requiring parenteral or oral antibiotic treatment.
5. Known HIV positivity.
6. Known active hepatitis B or C.
7. Clinical significant (i.e. active) cardiovascular disease:
a. Stroke within = 6 months prior to day 1
b. Transient ischemic attach (TIA) within = 6 months prior to day 1
c. Myocardial infarction within = 6 months prior to day 1
d. Unstable angina
e. New York Hart Association (NYHA) Class II or greater congestive heart failure (CHF)
f. Serious cardiac arrhythmia requiring medication
8. Other medications or conditions, including surgery, that in the Investigator’s opinion would contraindicate study participation for safety reasons or interfere with the interpretation of study results.
9. Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of 2X-121.
10. Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy.
11. Female patients who are pregnant or breast-feeding (pregnancy test with a positive result before study entry).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method