Biliary Cancer, Breast Cancer, Cancer, Colorectal Cancer, Neoplasms, Neoplasms, Breast, Ovarian Neoplasms, Pancreatic Cancer, PARP, Prostatic Cancer, Tumor
Conditions
Keywords
VB15010, PARP, Ovarian cancer, Prostatic Cancer, Pancreatic cancer, Breast cancer, Biliary Cancer
Brief summary
This research is designed to determine if experimental treatment with PARP1 inhibitor, VB15010 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.
Interventions
DRUGVB15010
Oral PARP1 inhibitor
Sponsors
Shandong Cancer Hospital and Institute
Zhejiang Yangli Pharmaceutical Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 at the time of screening; * Histological or cytological confirmation of advanced malignancy ; * Progressive cancer at the time of study entry; * Adequate organ and marrow function as defined by the protocol; * Homologous recombination repair gene mutation.
Exclusion criteria
* Major surgery within 4 weeks of the first dose of study treatment. * Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of \>10mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment. Patients with leptomeningeal carcinomatosis are excluded. * Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of subjects with adverse events/serious adverse events | From time of Informed Consent to 30+7 days post last dose | Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal ECG parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline |
| The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol. | At the end of Cycle 1(each cycle is 28 days) | A DLT is defined as any toxicity that occurs from the first dose of study treatment up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration of the drug (Cmax) | At predefined intervals throughout the treatment period (through study completion, an everage of 1 year) | The concentration of VB15010 in plasma will be determined (Cmax will be derived) |
| Objective Response Rate (prostate cancer) | From Screening to confirmed progressive disease (approximately 1 year) | Best response until progression, as defined by RECIST 1.1 or PCWG3 (bone) |
Countries
China
Contacts
Primary ContactSong Jia Project manager, bachelor
Backup ContactZhang Nan Assistant project manager, bachelor
Outcome results
None listed