2X-121 is a small molecule targeted inhibitor of Poly ADP ribose polymerase (PARP), a key enzyme involved in DNA damage repair in cancer cells. The PARP inhibitor demonstrated clinical activity in a prior Phase 1 study in a number of solid tumors. 2X-121 has a novel dual-inhibitory action against both PARP 1/2 and Tankyrase 1/2. The molecule is also active in P-glycoprotein expressing cells, suggesting it may overcome some of the PARP inhibitor resistance. The Phase 2 study is using 2x-121 DRP® biomarker in metastatic breast cancer patients to identify patients likely to respond to and benefit from treatment with 2X-121.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
600 mg PARP inhibitor 2X-121 as single daily oral agent in mBC patients
Herlev and Gentofte Hospital, Herlev Ringvej 75, DK-2730 Herlev
Herlev, Denmark
Vejle Sygehus
Vejle, Denmark
Anti-tumour efficacy after treatment with 600 mg 2X-121 as single oral agent in a 21-days cycle in mBC patients selected by the 2X-121 DRP
Overall tumor response according to RECIST
Time frame: one year
Progression free survival (PFS) after administration of 2X-121 in patients with mBC
Timespan
Time frame: one year
Duration of objective response after administration of 2X-121 in patients with mBC
Timespan
Time frame: one year
Overall survival (OS) after administration of 2X-121 in patients with mBC
Timespan
Time frame: one year
Performance status (ECOG)
To evaluate change in patient performance status by ECOG (Eastern Cooperative Oncology Group) Performance Status by a 6-step classification system
Time frame: one year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Adverse Events as assessed by CTCAE v4. to evaluate safety profile after administration of 2X-121 in patients with mBC
Time frame: one year
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