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An Open Label, Multicenter, Phase 2 Study to determine the safety and efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension), Administered to Patients with Metastatic Castration-Resistant Prostate Cancer
- To determine the efficacy of BIND-014 as measured by radiographic progression-free survival (rPFS) in patients with chemotherapy-na�ve metastatic CRPC
- To assess the safety and tolerability of BIND-014 in this patient population; and
- To assess the objective response rate in patients with measurable disease; and
- To assess the duration of response in patients with measurable disease; and
- To assess the PSA response; and
- To assess the time-to-PSA progression; and
- To assess overall survival (OS)
- To assess the impact on CTC counts; and
- To determine the expression of prostate-specific membrane antigen (PSMA) found on archival tumor tissue blocks collected from patients as assessed by immunohistochemistry staining, and explore if there is a correlation with efficacy.
- Males at least 18 years of age.
- Histologically or cytologically confirmed adenocarcinoma of the prostate.
- Metastatic disease that is progressing despite castrate levels of testosterone. Progressive disease may be defined by rising PSA, 2 or more new bone scan lesions, or new/expanding nodes or soft tissue lesions. If progressive disease by soft tissues/visceral lesions, they must be at least 10 mm in largest diameter in the absence of PSA and bone scan progression.
- Prostate cancer progression documented by PSA according to PCWG2 or radiographic progression according to modified RECIST criteria or PCWG2 bone scan progression. (see Protocol Attachment # 1)
- Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM). If the patient is being treated with LHRH agonists (patient who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to Cycle 1 Day 1 and must be continued throughout the study.
- Anti-androgen withdrawal if given as first-line anti-androgen therapy. Patients who received combined androgen blockade with an anti-androgen must have shown PSA progression after discontinuing the anti-androgen prior to Cycle 1 Day 1.
- Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale. (see Protocol Attachment # 2).
- Adequate organ function including the following:
- Adequate bone marrow reserve
- Absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 10^9/ L
- Platelets ≥ 100 x 10^9/ L (cannot be post-transfusion)
- Hemoglobin ≥ 9 g/ dL (can be post-transfusion, however, patients requiring chronic transfusions require input from Medical Monitor)
- Total bilirubin ≤ 1.5 times institutional upper limit of normal (ULN), (except for patients with Gilberts syndrome who are required to have a direct bilirubin ≤ 2.5 x institutional ULN)
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN. Note: If clearly attributable to liver metastasis, AST (SGOT) and ALT (SGPT) values < 5 times the ULN are permitted
- Renal: Calculated creatinine clearance (CrCI) ≥ 45 mL/min using the lean body mass formula only (Modified Cockroft and Gault; Shargel and Yu 1985, see Protocol Attachment # 5);
- Cardiac: Mean QTcF threshold value of ≤ 480 msec
- Prior radiation therapy allowed to ≤ 25% of the bone marrow (see Protocol Attachment # 3). Prior radiotherapy must be completed at least 4 weeks before Cycle 1 Day 1. Patients must have recovered from the acute toxic effects of the treatment prior to Cycle 1 Day 1.
- Prior hormonal, vaccine, and radiopharmaceutical therapy is allowed. Treatment with abiraterone (Zytiga), enzalutamide (Xtandi), fluconazole, itraconazole, flutamide, bicalutamide, nilutamide, and other experimental hormonal agents (ARN509, TAK-700, etc.), sipuleucel-T (Provenge), other experimental vaccines (PROSTVAC-V/F, etc.), Strontium-89, Samarium, and Radium-223 chloride (Xofigo), are allowed after a 4-week wash-out period or within the equivalent of 5 half-lives (prior to Cycle 1 Day 1), whichever is shorter.
- Patient compliance and geographic proximity that allow adequate follow-up.
- Patients who have partners with reproductive potential must use an approved contraceptive method if appropriate (e.g, intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after the study. Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study and for 1 month (30 days) following the last dose of study drug.
- All other screening procedures (as listed in Section 6.0) have been performed prior to enrollment.
- Signed informed consent from patient.
- Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated or intolerable.
- Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone twice daily.
- Pathological finding consistent with small cell carcinoma of the prostate.
- Patients who are symptomatic from known brain metastases (brain imaging [CT/MRI is not required]). Patients with asymptomatic brain metastases may be considered if they have completed their treatment for brain metastases. If clarification is needed, contact the Medical Monitor.
- Prior cytotoxic chemotherapy for the treatment of CRPC.
- Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack.
- Administration of an investigational therapeutic within 4 weeks or within the equivalent of 5 half-lives of Cycle 1, Day 1, whichever is shorter.
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment, except non-melanoma skin cancer or superficial bladder cancer, with a ≥ 30% probability of recurrence within 24 months.
- Presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
- History of severe hypersensitivity reaction (≥ Grade 3) to polysorbate 80 containing drugs (Examples of drugs containing polysorbate 80 include: docetaxel, cabazitaxel, etoposide or rituximab.)
- CTCAE Grade 3 or 4 peripheral neuropathy at study entry.
- Any condition which, in the opinion of the investigator, would preclude participation in this trial.
- Patients known to be HIV positive or seropositive for hepatitis C virus or hepatitis B virus.
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