Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2017-003508-39-DK
EUCTR2017-003508-39-DKActive, not recruitingPhase 1

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®.

Oncology Venture Aps0 sites26 target enrollmentStarted: January 2, 2018Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
26
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
Female

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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).

Investigators

Sponsor
Oncology Venture Aps

Similar Trials

Completed
Phase 2
To assess the safety and effectiveness of DPOR/JR2007 Tablets in Osteoarthritis of the Knee.
CTRI/2017/07/009054Deltas Pharma45
Completed
Phase 2
To evaluate the safety and efficacy of Arnophyte Cream in subjects with Herpes
CTRI/2018/01/011171Piramal Enterprises Limited40
Active, not recruiting
Not Applicable
A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple MyelomaMedDRA version: 9.1Level: PTClassification code 10028228Term: Multiple myelomaMultiple Myeloma
EUCTR2008-005112-41-DKSirtris Pharmaceuticals Inc.30
Active, not recruiting
Not Applicable
A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple MyelomaMultiple Myeloma
EUCTR2008-005112-41-GBSirtris Pharmaceuticals Inc.30
Active, not recruiting
Phase 1
An open-label clinical study to evaluate the safety and distribution in the body of a new drug (F901318), to be given as infusion, to prevent fungal infection in patients undergoing chemotherapy of leukemia.Infasive fungal disease in patients with acute myeloid leukemia under chemotherapyMedDRA version: 19.0Level: PTClassification code 10017533Term: Fungal infectionSystem Organ Class: 10021881 - Infections and infestations
EUCTR2016-000919-33-DEF2G Limited10