Safety Study of an Antisense Product in Prostate, Ovarian, NSCL, Breast or Bladder Cancer

Inclusion Criteria

• •Age ≥ 18 years at time of consent.
• •Histologically or cytologically confirmed diagnosis of one of the following: adenocarcinoma of the breast, ovary, or prostate, any NSCLC or bladder cancer.
• •Must have metastatic disease. Prostate cancer patients must be hormone refractory.
• •Must have failed therapies that are potentially curative; failed/refused standard therapy known to prolong survival or progression-free survival; or failed/refused therapy, that in the view of the investigator, would be beneficial in improvement of symptoms
• •Patients enrolled into Cohorts 6 and 7 (OGX 427 in combination with docetaxel) must have disease that has a possibility of responding to docetaxel.
• •A minimum of 28 days must have elapsed between any major surgery, the last dose of chemotherapy, radiotherapy (except limited fields-see #7 below), radioisotope, immunotherapy or experimental agent and enrollment onto the study. Note: Patients on hormone or estrogen therapy and steroids for treatment of their disease may remain on therapy.
• •A minimum of 7 days must have elapsed between a single fraction of ≤ 800 cGy to a limited field or conventional radiotherapy to a limited non marrow-bearing field such as an extremity or orbit and enrollment onto the study.
• •Recovery from all toxicities of prior therapy including chemotherapy, radiation therapy, immunotherapy and experimental agents to ≤ grade 2 by NCI CTCAE, version 3.0.
• •If not treated with bilateral orchiectomy, patients with HRPC must be willing to continue luteinizing hormone releasing hormone (LHRH) analogues throughout the study.
• •If taking opioid medication, patient must be willing to continue on the same opioid medication that they are on at enrollment through the PK/ECG evaluations during Cycle 1.
• •Karnofsky score of ≥60%.
• •Various laboratory requirements.
• •Must be willing to use effective contraception during and for 3 months following treatment if of child bearing potential.
• •Must be willing to undergo pharmacokinetic blood draws and frequent ECG monitoring on Days 1 and 2 of Cycle 1.
• •Must provide written, informed consent.