Clinical trial NCT02478125 (phase 1, status: terminated)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: burixafor hydrobromide, docetaxel, g-csf
SMILES: NC1=NC(NC[C@H]2CC[C@H](CNCCCNC3CCCCC3)CC2)=NC(=C1)N1CCN(CCP(O)(O)=O)CC1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, C(N1CCCNCCNCCCNCC1)C1=CC=C(CN2CCCNCCNCCCNCC2)C=C1
Reason stopped: 
    low accrual
  
Eligibility criteria:

        Inclusion Criteria:

          1. Have signed an informed consent document indicating that the subject understands the
             purpose of and procedures required for the study and are willing to participate in the
             study

          2. Be willing/able to adhere to the prohibitions and restrictions specified in this
             protocol

          3. Male aged 18 years and above

          4. Eastern cooperative group (ECOG) performance status ≤2

          5. Documented histologically confirmed adenocarcinoma of the prostate

          6. Metastatic prostate cancer to the bone as documented by positive bone scan imaging

          7. Patient must be eligible for chemotherapy with docetaxel

          8. Patient must have evidence of castrate resistant prostate cancer as evidenced by a
             confirmed rising PSA (per Prostate Cancer Working Group 2 [PCWG2] criteria) and a
             castrate serum testosterone level (i.e. ≤ 50 mg/dL).

        Exclusion Criteria:

          1. Have known allergies, hypersensitivity, or intolerance to docetaxel or dexamethasone
             or their excipients

          2. Prior pelvic radiation (e.g. external beam, brachytherapy, etc) that, in the opinion
             of the investigator, may lead to decreased bone marrow cellularity in a marrow sample
             obtained from a pelvic bone marrow biopsy

          3. Ongoing systemic therapy (other than a GnRH agonist/antagonist) for prostate cancer
             including, but not limited to:

               1. CYP-17 inhibitors (e.g. ketoconazole, abiraterone)

               2. Antiandrogens (e.g. bicalutamide, nilutamide)

               3. Second generation antiandrogens (e.g. enzalutamide)

               4. Immunotherapy (e.g. sipuleucel-T, ipilimumab)

               5. Chemotherapy (e.g. docetaxel, cabazitaxel)

          4. Prior radiopharmaceutical therapy (e.g. radium-223, strontium-89, samarium-153, etc)
             within the past year

          5. Have any condition that, in the opinion of the investigator, would compromise the
             well-being of the subject or the study or prevent the subject from meeting or
             performing study requirements

          6. Active infection or other medical condition that would make corticosteroids (i.e.
             dexamethasone) use contraindicated

          7. Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg) Patients
             with a history of hypertension are allowed provided blood pressure is controlled by
             anti-hypertensive treatment

          8. Severe hepatic impairment (Child-Pugh Class C)

          9. History of pituitary or adrenal dysfunction (note: the use of daily steroids does not
             exclude someone from participating in this study)

         10. Have poorly controlled diabetes (HgB A1C ≥ 8%)

         11. Any psychological, familial, sociological, or geographical condition that could
             potentially interfere with compliance with the study protocol and follow-up schedule.