ONC201 in Recurrent or Metastatic Type II Endometrial Cancer Endometrial Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    30
  • sponsor
    Oncoceutics, Inc.
Updated on 26 January 2021
renal function
metastatic disease
measurable disease
neutrophil count
chemotherapy regimen
carcinosarcoma
onc201

Summary

This is a a Simon's two-stage, non-randomized, open label, 2-arm Phase II trial of ONC201 in women with metastatic or recurrent Type II endometrial cancer who failed at least 1 prior chemotherapy regimen.

Details
Condition Recurrent Endometrial Cancer, Endometrial Cancer Recurrent
Treatment ONC201
Clinical Study IdentifierNCT03485729
SponsorOncoceutics, Inc.
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have Endometrial Cancer Recurrent?
Do you have any of these conditions: Endometrial Cancer Recurrent or Recurrent Endometrial Cancer?
Histologically confirmed metastatic or recurrent Type II EC (serous, clear cell, carcinosarcoma, adenosquamous and mixed histologies)
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria v.1.1
Availability of at least 12 unstained slides from archival FFPE tumor tissue
For Arm A, patients must have disease that is amenable to biopsy and must be willing to provide consent for a tumor biopsy at baseline (within 30 days of beginning ONC201) and at least 1 on-treatment tumor biopsy
Must have radiographic disease progression after at least 1 line of systemic cytotoxic therapy for metastatic disease or with progression within 12 months of completing adjuvant chemotherapy
Age > 18 years
ECOG performance status of 0, 1, or 2
Patients must have adequate bone marrow, hepatic and renal function as defined below
Leukocytes > 3,000/mcL
Absolute neutrophil count > 1,500/mcL
Platelets > 100,000/mcL
Total bilirubin 1.5 ULN
AST/ALT (SGOT/SGPT) < 2 ULN
Creatinine 1.5 ULN OR
Creatinine clearance > 60 Ml/min/1.73 m2 for patients with creatinine levels above ULN calculated using Calvert formula
Life expectancy at least 3 months
Ability to understand and willingness to sign a written informed consent and HIPAA consent document
Patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment

Exclusion Criteria

No prior treatment with ONC201
Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
The subjects who have not recovered to baseline or CTCAE Grade 1 from related toxicity to all prior therapies will be excluded. Patients with Non-serious adverse events such as alopecia, fatigue, weakness, loss of appetite and nausea that are non-significant will not be excluded
Any other prior malignancy from which the patient has been disease free for less than 3 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of any site
The subject is unable to swallow capsules
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of ONC201 (uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
Patients receiving any other investigational agents
Patients with symptomatic brain metastases are excluded. Patients with asymptomatic and treated CNS metastases may participate in this trial. The patient must have completed any prior treatment for CNS metastases > 28 days prior to study entry including radiotherapy or surgery. Steroids for the treatment of brain metastasis are not permitted, and patients must be stable off steroid treatment for 4 weeks prior to enrollment
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection. Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism
Active inflammatory gastrointestinal disease, chronic diarrhea (unless related to underlying malignancy or prior related treatment) or history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed
Known HIV-positive patients on combination antiretroviral therapy
Known history of HBV or HCV infection
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the patient inappropriate for entry into the study
Pregnant or breast feeding
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