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BIND 1813   |   13-602
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

Disease(s)
Prostate
Hospital(s)
Main Campus
Phase(s)
Phase 2
Stage(s)
Type(s)
Drug(s)
BIND-014

Contact Information
Cancer Answer Line

866.223.8100

8:00 am - 4:30 pm, Monday - Friday


Description
Primary
  1. To determine the efficacy of BIND-014 as measured by radiographic progression-free survival (rPFS) in patients with chemotherapy-na�ve metastatic CRPC
Secondary
  1. To assess the safety and tolerability of BIND-014 in this patient population; and
  2. To assess the objective response rate in patients with measurable disease; and
  3. To assess the duration of response in patients with measurable disease; and
  4. To assess the PSA response; and
  5. To assess the time-to-PSA progression; and
  6. To assess overall survival (OS)
Exploratory
  1. To assess the impact on CTC counts; and
  2. 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.

Inclusion Criteria
  1. Males at least 18 years of age.
  2. Histologically or cytologically confirmed adenocarcinoma of the prostate.
  3. 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.
  4. 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)
  5. 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.
  6. 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.
  7. Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale. (see Protocol Attachment # 2).
  8. Adequate organ function including the following:
  9. Adequate bone marrow reserve
    1. Absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 10^9/ L
    2. Platelets ≥ 100 x 10^9/ L (cannot be post-transfusion)
    3. Hemoglobin ≥ 9 g/ dL (can be post-transfusion, however, patients requiring chronic transfusions require input from Medical Monitor)
  10. Hepatic
    1. 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)
    2. 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
    3. 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);
    4. Cardiac: Mean QTcF threshold value of ≤ 480 msec
    5. 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.
    6. 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.
    7. Patient compliance and geographic proximity that allow adequate follow-up.
    8. 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.
    9. All other screening procedures (as listed in Section 6.0) have been performed prior to enrollment.
    10. Signed informed consent from patient.

Exclusion Criteria
  1. Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated or intolerable.
  2. Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone twice daily.
  3. Pathological finding consistent with small cell carcinoma of the prostate.
  4. 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.
  5. Prior cytotoxic chemotherapy for the treatment of CRPC.
  6. 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.
  7. Administration of an investigational therapeutic within 4 weeks or within the equivalent of 5 half-lives of Cycle 1, Day 1, whichever is shorter.
  8. 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.
  9. 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.
  10. History of severe hypersensitivity reaction (≥ Grade 3) to polysorbate 80 containing drugs (Examples of drugs containing polysorbate 80 include: docetaxel, cabazitaxel, etoposide or rituximab.)
  11. CTCAE Grade 3 or 4 peripheral neuropathy at study entry.
  12. Any condition which, in the opinion of the investigator, would preclude participation in this trial.
  13. Patients known to be HIV positive or seropositive for hepatitis C virus or hepatitis B virus.

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