chemotherapy-naïve metastatic castrate-resistant prostate cancer MedDRA version: 14.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: G-202
Product Code: G-202
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: G-202
Current Sponsor code: G-202
Other descriptive name: Thapsigargin pr
Sponsors
GenSpera, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Histologically- or cytologically-confirmed prostate adenocarcinoma 2. Evidence of radiographic metastatic or recurrent disease. The presence of sclerotic lesions seen on CT scans that are equivocal on the bone will be allowed if the investigator considers these to be metastases 3. Chemically- or surgically-castrated patient with documented disease progression as evidenced by one or more of the following three criteria: - Rising PSA, defined according to PCWG2 criteria - Nodal or visceral progression - Evidence of progression of bone metastases 4. In patients who have undergone chemical castration, a castrate testosterone level =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Prior chemotherapy for treatment of metastatic or recurrent prostate cancer 2. Other concurrent therapy for prostate cancer other than LHRH agonists or antagonists. LHRH agonists or antagonists must have been taken at a steady dose for at least 3 months prior to study entry. The following must be discontinued and cannot be taken within 4 weeks of study entry: 5a-reductase inhibitors (e.g., finasteride, dutasteride), ketoconazole (if given for more than 7 days), aminoglutethimide, megestrol, diethylstilbestrol (DES), abiraterone acetate, MDV3100 (enzalutamide), TAK700, sipuleucel-T. Replacement doses of glucocorticoids are allowed; but chronic daily use of glucocorticoids for prostate cancer is not allowed 3. Treatment with therapeutic radionucleotides, such as strontium chloride (Sr89), samarium (Sm153) lexidronam pentasodium, or radium-223 within 12 weeks of study entry 4. Radiation therapy 470 msec (Appendix V) 12. Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study 13. Active uncontrolled infection, including known history of AIDS, hepatitis B or C 14. Proteinuria level > +2 on urine analysis 15. Any psychological condition or geographical situation that could potentially interfere with compliance with the study protocol and follow-up schedule. 16. The patient is or is expected to be concurrently receiving any other investigational agents while on study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the percentage of patients with chemotherapy-naïve metastatic castrate-resistant prostate cancer who do not have disease progression (radiographic or clinical) after 24 weeks of treatment with G-202.;Secondary Objective: Investigate the safety profile and clinical activity of G-202 administered by intravenous infusion daily for 3 consecutive days on a 28-day cycle in patients with chemotherapy-naïve metastatic castrate-resistant prostate cancer.;Primary end point(s): Percentage of patients who are progression-free after 24 months of treatment with G-202.;Timepoint(s) of evaluation of this end point: Radiographic disease progression is measured every 12 weeks. Clinical symptoms of progression are measured on an ongoing basis throughout the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Maximum PSA change from baseline at any time 2. Percent change in PSA level from baseline to 24 weeks 3. Time to PSA progression by PCWG 2 criteria. 4. PSA doubling time. 5. Best objective response rate (i.e., the percentage of patients with measureable visceral and/or nodal metastatic disease at baseline who achieve complete or partial response) at any time point after initiation of G-202 treatment as assessed by the PCWG2 criteria. 6. Time to disease progression (clinical or radiographic). 7. Progression-free survival time. 8. Proportion of patients experiencing treatment emergent adverse events, according to NCI Common Toxicity Criteria, version 4.03 ;Timepoint(s) of evaluation of this end point: 1 - 4. PSA measured at screening, day 1 of treatment cycles after cycle 1, and at the 30 day follow up. 5 & 6. Radiographic progression measured by CT and bone scan at screening and repeated every 12 weeks throughout the duration of the study. Clinical assessments for progression are performed on an ongoing basis during the course of clinic visits for the duration of the study. 7. Timepoints not applicable for survival data as recorded on ongoing basis. 8. AEs collected on ongoing basis for the duration of the study. | — |
Countries
United Kingdom, United States
Contacts
Public ContactProject Manager G-202-002
Nexus Oncology Ltd
Outcome results
None listed