Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer
Unknown Primary
18 Years and older, Male and Female
Summary
This is a 2-part, Phase 2 study to evaluate the safety, tolerability, dosing,
pharmacokinetics (PK), and efficacy of relacorilant in combination with nab-paclitaxel
and gemcitabine in chemotherapy-naïve patients with metastatic pancreatic adenocarcinoma
(PDAC).
Objectives
This study will include 2 parts. In Part 1 (dose finding), approximately 6 patients will
be enrolled to individual dose-finding cohorts. Cohorts will receive various dose
concentrations of relacorilant, nab-paclitaxel, and gemcitabine at various dosing
schedules. In all dose-finding cohorts, relacorilant will be administered orally under
fed conditions, once daily for 3 days on the day before (excluding Cycle 1 Day -1), the
day of, and the day after nab-paclitaxel and gemcitabine. Enrollment will be paused after
each cohort has been filled until the safety review committee (SRC) provides
recommendations. If maximum tolerated dose (MTD) criteria are not met in a cohort, then
either a dose-finding cohort at a more intense dose and/or schedule may be enrolled, or a
dose and schedule at/below the MTD may be selected as the optimal dose and schedule, and
Part 2 may be initiated. If MTD criteria are met, then a dose-finding cohort at a less
intense dose and/or schedule may be enrolled, or dose-finding may end without proceeding
to Part 2.
In Part 2 (expansion), each patient will receive the optimal dose and schedule of
relacorilant, nab-paclitaxel, and gemcitabine as identified in Part 1. Analysis of Part 2
will include data for patients from Part 1 who were enrolled in the optimal dose and
schedule used in Part 2.
Eligibility
- Signed and dated informed consent form prior to screening procedures
- Histologic diagnosis or cytologic diagnosis of pancreatic adenocarcinoma (PDAC)
- Initial diagnosis of metastatic disease occurred =9 weeks prior to enrollment in the study
- Life expectancy of =3 months
- Radiographic confirmation of metastatic disease with at least 1 distant tumor metastasis measurable on radiology imaging per RECIST version 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Able to provide informed consent and comply with protocol requirements
- Able to swallow and retain oral medication and does not have uncontrolled emesis
- Has adequate gastrointestinal absorption
- Received no prior systemic anticancer chemotherapy to treat metastatic PDAC. Treatment of PDAC with a single agent RAS inhibitor is permitted.
- If a patient received prior treatment of PDAC with chemotherapy, disease progression must have occurred >12 months after completing the last dose, and no persistent treatment-related toxicities can be present.
- Adequate organ function
- Negative pregnancy test for patients of childbearing potential
- Agree to use protocol defined precautions to avoid pregnancy
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