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A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT05043922
Recruitment Status : Not yet recruiting
First Posted : September 14, 2021
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
Haihe Biopharma Co., Ltd.

Brief Summary:
The purpose of this study is to determine the treatment efficacy of CYH33 monotherapy in patients with recurrent or persistent ovarian, fallopian tube or primary peritoneal clear cell carcinoma, who received prior systemic anti-tumor treatment.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Recurrent Cancer Drug: CYH33 Phase 2

Detailed Description:
The purpose of this study is to determine whether treatment with single agent CYH33 significantly improves ORR compared to historical efficacy data in patients with recurrent/persistent ovarian clear cell carcinoma (OCCC) harboring PIK3CA hotspot mutations who received prior systemic anti-tumor treatment.

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Study Type : Interventional
Estimated Enrollment : 228 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of CYH33, a Selective PI3Kα Inhibitor in Patients With Recurrent/Persistent Ovary, Fallopian Tube or Primary Peritoneal Clear Cell Carcinoma
Estimated Study Start Date : September 9, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023


Arm Intervention/treatment
Experimental: CYH33
40mg daily
Drug: CYH33
a Selective PI3Kα Inhibitor




Primary Outcome Measures :
  1. Tumor ORR in patients with PIK3CA hotspot mutations. [ Time Frame: through study completion, an average of 1 year ]
    Tumor ORR per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 in patients with PIK3CA hotspot mutations.


Secondary Outcome Measures :
  1. ORR in patients without PIK3CA hotspot mutations. [ Time Frame: through study completion, an average of 1 year ]
    ORR per RECIST v1.1 in patients without PIK3CA hotspot mutations.

  2. PFS [ Time Frame: through study completion, an average of 1 year ]
    PFS by BIRC using RECIST v1.1

  3. OS [ Time Frame: through study completion, an average of 2 year ]
    OS in each of the PIK3CA mutation status cohort

  4. genetic and protein biomarker alterations [ Time Frame: through study completion, an average of 1 year ]
    genetic and protein biomarker alterations that can impact PI3K signaling pathway


Other Outcome Measures:
  1. Safety and tolerability [ Time Frame: through study completion, an average of 1 year ]
    type, incidence, duration, severity and seriousness of adverse events (AEs)

  2. DLT (Dose Limiting Toxicity) in Japanese patients [ Time Frame: 4 weeks ]
    Number and proportion of patients who experienced DLT during the first 28-day of treatment in Japanese patients in safety run-in study.

  3. Peak Plasma Concentration (Cmax) [ Time Frame: 4weeks ]
    Pharmacokinetics parameters

  4. Area under the plasma concentration versus time curve (AUC) [ Time Frame: 4weeks ]
    Pharmacokinetics parameters



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  1. Female patients ≥ 18 years of age
  2. Provide informed consent voluntarily.
  3. Patients must have histologically or cytologically confirmed recurrent or persistent ovarian, fallopian tube, or peritoneum clear cell carcinoma.
  4. Patients with recurrent/persistent ovary, fallopian tube or primary peritoneal clear cell carcinoma, who have identified PIK3CA status (with or without PIK3CA hotspot mutations).
  5. Patients must have failed standard chemotherapy.
  6. ECOG-PS ≤ 1.
  7. Patient must have adequate organ and bone marrow function measured within 28 days of screening.

Main Exclusion Criteria:

Patients are ineligible for this study if they meet any of the following criteria:

  1. Patient has received any anticancer therapy
  2. Patients who had prior treatment with any PI3K, mTOR or AKT inhibitor.
  3. Radical radiation therapy within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks.
  4. Any toxicities from prior treatment that have not recovered to baseline.
  5. Patients who have been treated with any hematopoietic colony-stimulating growth factors ≤ 2 weeks prior to starting study drug.
  6. Patients who have symptomatic CNS metastasis.
  7. Major surgery or had significant traumatic injury within 28 days prior to the first dose of the investigational product or has not recovered from major side effects.
  8. Known HIV infection with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunity infection within the past 12 months; active hepatitis B and hepatitis C.
  9. History of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis.
  10. Patients with clinically significant cardiovascular disease
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Responsible Party: Haihe Biopharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT05043922    
Other Study ID Numbers: CYH33-G201
First Posted: September 14, 2021    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haihe Biopharma Co., Ltd.:
Phase 2 study
Pharmacokinetics
Additional relevant MeSH terms:
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Adenomyoepithelioma
Adenocarcinoma, Clear Cell
Recurrence
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Neoplasms, Complex and Mixed
Adenocarcinoma