Phase 2
Completed N=200
Phase 2 Study of Docetaxel +/- OGX-427 in Patients With Relapsed or Refractory Metastatic Bladder Cancer
Source: ClinicalTrials.gov NCT01780545 ↗Enrolled (actual)
200
Serious AEs
50.5%
Results posted
Nov 2017
Primary outcomePrimary: Overall Survival — 6.4; 5.9 months
Summary
This is a randomized, open-label Phase 2 clinical trial to evaluate whether suppression of Hsp27 (Heat shock protein 27) production using OGX-427, a second-generation antisense oligonucleotide (ASO), in combination with docetaxel can prolong survival time compared to docetaxel alone in participants with locally advanced or metastatic urothelial carcinoma (UC) that are relapsed or refractory after receiving a platinum-containing regimen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
6.4; 5.9 | — |
| SECONDARY Safety and Toxicity of Regimen |
0; 2; 6; 7; 11; 15 | — |
| SECONDARY Overall Response Rate |
— | — |
| SECONDARY Overall Survival (OS) According to Baseline Serum Hsp27 Level. |
9.4; 4.7 | — |
| SECONDARY Hsp27 Expression in Archival Tissue |
— | — |
| SECONDARY Effect of Therapy Regimen on Circulating Tumor Cells (CTCs)and Correlative Analysis of Telomerase Activity |
— | — |
Eligibility Criteria
Inclusion Criteria
- Participants must have histologically documented metastatic or locally inoperable advanced urothelial carcinoma (bladder, urethra, ureter and renal pelvis) (T4b, N2, N3, or M1 disease. NOTE: Aberrant differentiation such as squamous, glandular (adenocarcinoma), and micropapillary are eligible unless the tumor is considered a pure histological variant according to the pathology report. Participants with small cell histology are not eligible.
- Participants must have measurable disease defined as at least one target lesion that has not been irradiated and can be accurately measured in at least one dimension by RECIST v1.1 criteria.
- Participants must have received prior systemic chemotherapy treatment for metastatic urothelial carcinoma. NOTE: Up to 2 prior systemic chemotherapeutic regimens given in the metastatic disease setting for urothelial carcinoma are allowed.
- Specifically, subjects must meet one or more of the following criteria:
- Progression during or after treatment with a regimen that includes a platinum salt (e.g., carboplatin or cisplatin) OR
- Disease recurrence within one year after neoadjuvant or adjuvant platinum-based systemic chemotherapy, measured from the date of last dose of chemotherapy or surgery until the day the informed consent is signed
- Participants must be ≥18 years since no dosing or adverse event data are currently available on the use of OGX-427 in participants 30%) of recurrence during the study.
Data sourced from ClinicalTrials.gov (NCT01780545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.