Onvansertib + Paclitaxel In TNBC (NCT05383196) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Onvansertib + Paclitaxel In TNBC
United States50 participantsStarted 2022-09-30
Plain-language summary
This research is being done to evaluate the safety and effectiveness of Onvansertib in combination with Paclitaxel in triple-negative breast cancer (TNBC) that has spread to other parts of the body.
The names of the study interventions involved in this study are:
* Onvansertib
* Paclitaxel
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed invasive breast cancer with unresectable locally advanced or metastatic disease, included inflammatory breast cancer
* Histologically or cytologically-confirmed triple negative breast cancer (defined as ER ≤ 10%, PR ≤ 10%, Her-2-neu negative per ASCO/CAP 2018 guidelines: 0-1+ by IHC or FISH-negative)
* Concurrent endocrine therapy will not be allowed for patients with ER/PR ≥1%
* Age ≥ 18 years
* ECOG Performance Status of 0 or 1.
* Subjects must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
* Subject is not receiving any other cancer therapy. Subjects participating in surveys or observational studies are allowed.
* Subjects with treated brain metastases that are stable on imaging for at least four weeks prior to registration and who are off steroid therapy are eligible. Subjects with small, asymptomatic incidental brain metastases that require no immediate treatment, including steroids, are also eligible.
* For a male or a woman of child-bearing potential (WOCBP): Must agree to use contraception or take measures to avoid pregnancy during the study and for 180 days of the final dose of any study drug.
* Adequate contraception is defined as follows:
* Complete true abstinence.
* Consistent and correct use of one of the following methods of birth control:
* Male partner who is sterile prior to the female …
What they're measuring
1
Dose-Limiting Toxicity (DLT)-Phase Ib
Timeframe: during the first cycle of therapy (28 days).
2
Incidence of Grade 3 or Higher Treatment-Related Toxicity- Phase Ib
Timeframe: during the first cycle of therapy (28 days).
3
Overall Response Rate (ORR) Phase II
Timeframe: Every 8 weeks until disease progression, in average 24 weeks