A Phase 2, Randomized, Open-label, 3-arm Study of Relacorilant in Combination with Nab-Paclitaxel for Patients with Platinum Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Corcept Therapeutics Incorporated0 sites177 target enrollmentJune 11, 2019

ConditionsRecurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer MedDRA version: 20.0 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10016180 Term: Fallopian tube cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10061344 Term: Peritoneal neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsAbraxane

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Sponsor: Corcept Therapeutics Incorporated
Enrollment: 177
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 11, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Corcept Therapeutics Incorporated

Eligibility Criteria

Inclusion Criteria

•1\. Signed and dated IRB/IEC\-approved informed consent form (ICF) prior to study\-specific screening procedures.
•2\. Female patients aged \= 18 years old at time of consent.
•3\. Histologic diagnosis of high grade serous or endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer or ovarian carcinosarcoma. Clear cell, mucinous and borderline histologic subtypes are excluded.
•4\. Received at least one line of therapy with progression within 6 months after platinum\-based therapy, persistent disease at the completion of primary platinum\-based therapy, or PD during platinum\-based therapy. Patients with primary platinum resistance (progression after first\-line chemotherapy) are considered eligible.
•5\. Measurable or non\-measurable disease by RECIST v1\.1:
•? Previously irradiated lesions are not allowed as measurable disease, unless there is documented evidence of progression in the lesions.
•? To be eligible with non\-measurable disease, patients must have evaluable disease with CA\-125 of at least twice the upper limit of the reference range (or CA\-125 \= 70 U/mL) along with radiographically evaluable disease by CT/MRI.
•6\. Availability and consent to provide tumor tissue for GR immunohistochemistry (archival or recent biopsy).
•7\. Up to 2 prior chemotherapeutic or myelosuppressive regimens for recurrent disease (not including maintenance therapy such as single\-agent bevacizumab).
•8\.Appropriate to treat with nab\-paclitaxel, in the opinion of the Investigator.

Exclusion Criteria

•1\. Clinically relevant toxicity from prior systemic anticancer therapies or radiotherapy that in the opinion of the Investigator has not resolved to Grade 1 or less prior to randomization.
•2\. Any major surgery within 4 weeks prior to randomization. If subject received major surgery including (curative or palliative surgery), they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
•3\. Treatment with the following prior to randomization:
•? Concurrent treatment with other anticancer therapy including other chemotherapy, immunotherapy, radiotherapy, chemo\-embolization, targeted therapy, an investigational agent or the non\-approved use of a drug or device within 28 days before the first dose of study drug.
•? Hormonal anticancer therapies within 7 days of the first dose of study drug.
•? Systemic, inhaled, or prescription strength topical corticosteroids within 21 days of the first dose of study drug. Short courses (\= 5 days) for non\-cancer\-related reasons are allowed if clinically required (such as prophylaxis for CT).
•4\. Received radiation to more than 25% of marrow\-bearing areas.
•5\. Toxicities of prior therapies (except alopecia) that have not resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI\-CTCAE) v5\.0 \= Grade 1\.
•6\. Requirement for treatment with chronic or frequently used oral corticosteroids for medical conditions or illnesses (e.g., rheumatoid arthritis, immunosuppression after organ transplantation).
•7\. History of severe hypersensitivity or severe reaction to either study drug.