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Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma

ConditionsAdenocarcinomaCarcinoma, Pancreatic Ductal
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCorcept Therapeutics

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Any major surgery within 4 weeks prior to enrollment

Radiotherapy, surgery, chemotherapy, immunotherapy, investigational therapy for the treatment of metastatic disease

Systemic, inhaled, or prescription strength topical corticosteroids within 5 times the half-life of the corticosteroid used prior to first dose of study drug

Received gemcitabine or nab-paclitaxel to treat their PDAC

Trial design

Design model

Sequential

Treatments tested in this trial

  • Relacorilant

    Drug

    Relacorilant will be administered as capsules for oral dosing.

  • Nab-paclitaxel

    Drug

    Nab-paclitaxel will be administered via IV infusion.

  • Gemcitabine

    Drug

    Gemcitabine will be administered via IV infusion.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Relacorilant in Combination with Nab-paclitaxel and GemcitabineExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Percent of Patients who Experience Dose Limiting Toxicity (DLT) (Part 1)

The percentage of patients with a DLT is used to estimate maximum tolerated dose (MTD), the most intense dose/schedule among those evaluated at which \<33% of patients experience DLT.

Time frame
Up to 28 days after the first dose of study treatment
2

Number of Patients with 1 or More Adverse Events (AEs) Leading to Study Drug Discontinuations or Dose Modifications (Part 1)

Time frame
Time of first dose up to 30 days after last dose
3

Progression-Free Survival (PFS) (Part 2)

To evaluate PFS as the time from enrollment until first documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by the Investigator, or death due to any cause, whichever comes first.

Time frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months

Secondary outcomes

1

Maximum Plasma Concentration (Cmax) of Relacorilant (Part 1 and Part 2)

Time frame
Pre- and postdose on Cycle 1 Day 15 (each cycle is 28 days)
2

Area Under the Plasma Concentration-time Curve (AUC) of Relacorilant (Part 1 and Part 2)

Time frame
Pre- and postdose on Cycle 1 Day 15 (each cycle is 28 days)
3

Cmax of Nab-paclitaxel (Part 1 and Part 2)

Time frame
At serial timepoints postdose on Cycle 1 Day 15 (each cycle is 28 days)
4

AUC of Nab-paclitaxel (Part 1 and Part 2)

Time frame
At serial timepoints postdose on Cycle 1 Day 15 (each cycle is 28 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Corcept Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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