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CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer

ConditionRecurrent Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLan Coffman

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with platinum-sensitive recurrent ovarian, fallopian or primary peritoneal cancer (defined as recurrent disease > 6 months after completing last platinum- based chemotherapy) that are eligible to receive platinum-based chemotherapy).

Documented disease recurrence/progression based on GCIG-RECIST

Must have had at least 1 prior line of platinum-based therapy, prior bevacizumab or PARPi use are allowed. Women with germline BRCA mutations should be considered for PARPi maintenance as standard of care treatment prior to consideration of clinical trial enrollment

Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 with life expectancy of ≥ 3months

Disqualifiers

Borderline or low malignant potential histology

Platinum-resistant disease (as defined as progressive disease (PD) within 6 months of completion of chemotherapy with a platinum agent).

Known hypersensitivity to any of the excipients of CPI-0209.

Gastrointestinal (GI) dysfunction or disease that may significantly alter the absorption of the study drugs

Trial design

Design model

Sequential

Treatments tested in this trial

  • CPI-0209

    Drug

    A second-generation EZH2 inhibitor that has been designed to achieve comprehensive anti-cancer target coverage through extended on-target residence time.

  • carboplatin

    Drug

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: CPI-0209 (100 mg) + carboplatinExperimental treatment 2 interventions
Group B: CPI-0209 (150 mg) + carboplatinExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Maximum 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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

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

Lan Coffman

Lead sponsor

University of Pittsburgh

Sponsor institution

Novartis Pharmaceuticals

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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