This is a clinical trial using CPI-0209 in combination with Carboplatin chemotherapy followed by CPI-0209 maintenance in patients with platinum sensitive, recurrent ovarian cancer.
Clinically, there is a critical need for improved therapies in ovarian cancer. There has been recent success with maintenance therapy in ovarian cancer with both PARP inhibitors and bevacizumab approved in the up-front maintenance setting and in the recurrent, platinum sensitive maintenance setting. However, it is unclear what treatment should be used post-PARPi or bevacizumab maintenance. Additionally, the benefit derived from bevacizumab maintenance therapy is modest with generally a few month improvement in progression free survival. Further, there is emerging evidence that after progression on a PARPi, there is decreased response to platinum-based therapy. This provides a critical unmet need to enhance platinum response, particularly after previous maintenance therapy. This also provides a large group of patients who could potentially benefit from EZH2 targeting agents to block stromal-mediated chemotherapy resistance and metastasis. This study aims to investigate whether CPI-0209 will enhance ovarian cancer sensitivity to platinum-based chemotherapy and prolong the disease free interval after completion of chemotherapy by blocking stromal mediated chemotherapy resistance, metastasis promotion and ovarian cancer growth.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
A second-generation EZH2 inhibitor that has been designed to achieve comprehensive anti-cancer target coverage through extended on-target residence time.
Carboplatin is a chemotherapy drug that contains the metal platinum. It stops or slows the growth of cancer cells and other rapidly growing cells by damaging their DNA.
Magee-Womens Research Institute / UPMC Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
RECRUITINGMaximum tolerated dose (MTD) of CPI-0209
MTD will be determined via Dose-limiting toxicity (DLT)s defined as any grade 3-4 non-hematological or grade 4 hematological toxicity at least possibly related to the treatment, occurring during the first two cycles of treatment and per Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Time frame: Up to 24 months
Adverse Events by Grade per CTCAE v5.0
Number of patients that experienced grade 3 or greater Adverse events per the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 5, determined to be at least possibly, probably or definitely related to treatment.
Time frame: Up to 5.5 years
Overall Response Rate (ORR)
Proportion of patients with Complete Response (CR) or Partial Response (PR) per RECIST v 1.1. Per RECIST v1.1: CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. PR is defined as ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: 5.5 years
Progression-free Survival (PFS)
The length of time during and after treatment that a patient lives with disease but without disease progression. Per RECISIT v1.1: Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Time frame: Up to 5.5 years
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