Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers

Korábbi kezelés

• Arm A Only: Has progressed while receiving weekly paclitaxel or nab-paclitaxel
• Prior enrollment in a clinical trial of relacorilant
• Prior anticancer therapy related toxicities not resolved to grade ≤1
• Any surgery within 4 weeks prior to enrollment
• Wide-field radiation to more than 25% of marrow-bearing areas
• Medical conditions requiring chronic or frequent treatment with corticosteroids
• Concurrent treatment with mifepristone or other glucocorticoid receptor modulators
• Bowel obstruction ≤12 weeks prior to study entry
• Has received a live vaccine within 30 days prior to the study start date
  • Arm C
• Has progressed while receiving weekly paclitaxel or nab-paclitaxel
• Prior enrollment in a clinical trial of relacorilant
• Prior anticancer therapy related toxicities not resolved to grade ≤1
• Any surgery within 4 weeks prior to enrollment
• Wide-field radiation to more than 25% of marrow-bearing areas
• Medical conditions requiring chronic or frequent treatment with corticosteroids
• Concurrent treatment with mifepristone or other glucocorticoid receptor modulators
• Bowel obstruction ≤12 weeks prior to study entry
• Has received a live vaccine within 30 days prior to the study start date
• Patients with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study.

Más betegség

• Hypertension: ≥150 mm Hg systolic or ≥100 mm Hg diastolic
• Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation
• History of other malignancy within 3 years prior to enrollment
• Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation
• History of other malignancy within 3 years prior to enrollment

Egyéb

• Arm A and B
• Peripheral neuropathy from any cause >Grade 1
• Ascites or pleural effusions requiring therapeutic paracentesis
• Untreated or symptomatic central nervous system metastases
• Peripheral neuropathy from any cause >Grade 1
• Ascites or pleural effusions requiring therapeutic paracentesis

• Arms A and B
• Histologic diagnosis of epithelial ovarian, primary peritoneal, or fallopian-tube carcinoma
• Arm A Only: Platinum-resistant disease
• Arm B Only: Platinum-sensitive disease who had progression while receiving treatment with a poly(ADP-ribose) polymerase (PARP) inhibitor
• Life expectancy of ≥3 months
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Able to swallow and retain oral medication
• 1 to 3 lines of prior systemic anticancer therapy
• Adequate organ function
• Negative pregnancy test for patients of childbearing potential
  • Arm C
• Stage III or IV, recurrent, or metastatic endometrial cancer
• Life expectancy of ≥3 months
• ECOG performance status of 0 or 1
• Able to swallow and retain oral medication
• Prior treatment with a platinum agent and an approved anti-Programmed Cell Death Ligand 1 (PD[L]1) antibody
• 1 to 2 lines of prior systemic anticancer therapy for endometrial cancer
• Must consent to provide an available formalin-fixed paraffin-embedded (FFPE) tumor tissue block or recently cut sections
• Adequate organ function
• Negative pregnancy test for patients of childbearing potential