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Study ID ARN-AR18-CT-102
Investigator
Title Phase 1-2 Study of Onapristone in Patients With Advanced Castration-resistant Prostate Cancer
Conditions Prostate Cancer
Metastatic Prostate Cancer
Androgen-independent Prostate Cancer
Recurrent Prostate Cancer
Interventions Drug: onapristone
Phase Phase 1/Phase 2
Purpose This study will evaluate an extended-release (ER) formulation of onapristone in patients with prostate cancer in which Progesterone Receptor (PR) may be contributing to tumor progression. A companion diagnostic to select patients whose prostate cancer expresses the activated form of the PR (APR) is under development and will be implemented in this study; it may be used to further enrich the selection of the population based upon ongoing review of the results. Patients will be treated until occurrence of an intolerable safety issue, treatment failure, if patient elects to withdraw, or for non-compliance with either protocol-specified evaluations or onapristone treatment. An additional cohort of patients will be included at the recommended phase 2 dose to gain additional understanding of the onapristone safety profile and potential anti-cancer activity.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
Inclusion Criteria:
  • Male patients, 18 years of age or greater;
  • Histologically confirmed adenocarcinoma of the prostate (without neuroendocrine differentiation or small cell features). For Stage 2 of the study, PR expression in ≥1% tumor cells;
  • Biopsy to determine current AR/PR and APR status
  • Metastatic or recurrent inoperable disease after previous surgery, radiation therapy, and/or chemotherapy;
  • No more than two prior chemotherapy regimens for CRPC (docetaxel rechallenge will be regarded as one line of chemotherapy);
  • Disease that has progressed by PSA on abiraterone or enzalutamide as the last line of treatment. Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration);
  • Serum testosterone level < 1.7 nmol/L (50 ng/dL);
  • Patients receiving bisphosphonate therapy must have been on stable doses for at least 4 weeks;
  • Evaluable disease per RECIST 1.1 or Prostate Cancer Clinical Trials Working Group 2;
  • ECOG performance status 0-2;
  • Life expectancy ≥ 3 months;
  • Willing and able to sign written informed consent. Exclusion Criteria:
  • Serum creatinine >1.5 ULN;
  • On ECG a QTc(F) interval >480 msec or any clinically significant cardiac rhythm abnormalities;
  • Liver function tests documented within the screening period and/or at baseline: - Total bilirubin > ULN (except in patients diagnosed with Gilbert's disease); - Alkaline phosphatase > 2.5 x UNL, unless test for alkaline phosphatase isoenzymes is elevated only for bone isoenzyme; - ALT/AST > UNL or > 2.5 x UNL in case of liver metastases;
  • Absolute neutrophil count < 1,500/μL, platelet count < 100,000/μL, and hemoglobin < 5.6 mmol/L (9 g/dL) and no growth factors or blood transfusions within 7 days of these values;
  • Serum albumin < 25 g/L (2.5 g/dL);
  • Known positive virology/serology for HIV, HBV or HCV
  • Chronic inflammatory liver condition. History or clinical evidence of any liver or biliary pathology;
  • Patients with any other prior malignancy are not allowed except for: - Adequately treated basal cell or squamous cell skin cancer; - Adequately treated Stage I or II cancer from which the patient is currently in complete remission; - Other cancer from which the patient has been disease-free for 2 years;
  • Chronic adrenal failure or is receiving concurrent long-term corticosteroid therapy
  • History or clinical evidence of any surgical or medical condition which the investigator judges as likely to interfere with the results of the study or pose an additional risk in participating;
  • Used any prescription medication during the prior 2 weeks that the investigator judges is likely to interfere with the study or to pose an additional risk to the patient in participating;
  • Received an investigational product or been treated with an investigational device within 30 days prior to first drug administration, or plans to start any other investigational product or device study within 30 days after last drug administration;
  • Received any of a number of specific anti-cancer therapies with known efficacy within predetermined timeframes prior to receipt of first dose of study drug, without withdrawal response and with no plans to initiate any of these during study;
  • Concurrent use of herbal products that may decrease PSA levels (e.g., saw palmetto);
  • Residual toxicity of prior anticancer treatment > grade 1 except for alopecia;
  • Brain metastases, active epidural disease or spinal cord compression, unless treated at least 4 weeks before entry, and stable with steroid treatment for ≥1 week;
  • Paget's disease of the bone;
  • Structurally unstable bone lesions suggesting impending fracture;
  • Patients with reproductive potential not employing adequate contraception during treatment and for 1 month after completing treatment;
  • Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to swallow pills;
  • Mental incapacity or language barriers precluding adequate understanding, cooperation, and compliance with the study requirements;
  • Is, in the judgment of the investigator, unable or unwilling to comply with the requirements of the study.
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    Information objtained from ClinicalTrials.gov, on 10/20/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
    Please refer to this study by its ClinicalTrials.gov identifier: NCT02049190


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