Advanced Solid Tumors
Conditions
Keywords
Breast cancer, PARP, Primary peritoneal cancer, Fallopian tube, Ovarian cancer, veliparib, ABT-888, BRCA
Brief summary
This is a Phase 1 study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of single agent Veliparib in Japanese subjects with advanced solid tumors.
Interventions
Subjects will be given veliparib twice daily on Days 1-28 every 28 days orally.
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed malignant solid tumor, and any of the following: \* Subjects with recurrent high grade serous ovarian cancer who completed or discontinued platinum based therapy; \* Subjects with BRCA-mutated breast cancer who have received prior chemotherapy with anthracycline and/or taxanes; \* Subjects with deleterious mutations of BRCA with advanced solid tumors who have received available standard therapies. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Life expectancy of greater than 12 weeks. * Adequate organ and marrow function· Measurable or non-measurable disease.
Exclusion criteria
* Major surgery and/or radiation within (\<) 4 weeks prior to study enrollment. * Chemotherapy or hormone therapy within (\<) 4 weeks prior to study enrollment except for mitomycin C and nitrosoureas, in which case it is 6 weeks. * Any investigational agents within (\<) 4 weeks prior to study enrollment. * Any anti-cancer Chinese medicine/herbal remedies within 14 days prior to study enrollment. * Toxicities (with the exception of alopecia) from prior major surgery, radiation, or systemic chemotherapy have not recovered to less than grade 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicities of veliparib | During the first cycle (28 days) of veliparib administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in participant clinical lab results | Approximately 1 year | Hematology, Chemistry and Urinalysis |
| Number of participants with adverse events | Approximately 1 year | Collect all adverse events at each visit and assess according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 |
| Preliminary tumor response | Participants will be followed for the duration of an expected average of 8 months. | According to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 |
| Change in participant physical exam measurements | Approximately 1 year | Blood pressure, pulse and body temperature |
| The time to Cmax (peak time, Tmax) | For 24 hours following veliparib dosing. | The time at which maximum plasma concentration (Cmax) is observed. |
| The area under the plasma concentration-time curve (AUC) | For 24 hours following veliparib dosing. | — |
| Maximum observed plasma concentration (Cmax) | For 24 hours following veliparib dosing. | Maximum observed concentration, occurring at Tmax |
Countries
Japan
Outcome results
None listed