Phase 2
Completed N=41
A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder Cancer
Bladder Cancer · Urethra Cancer · Ureter Cancer · Kidney Cancer
Source: ClinicalTrials.gov NCT00661609 ↗
Enrolled (actual)
41
Serious AEs
34.2%
Results posted
Jan 2011
Primary outcomePrimary: Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) — 2.6 Percengate of participants
Summary
The purpose of this Phase II study is to determine if AZD4877, an experimental drug that is a novel anti-mitotic agent (Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor cell division leading to tumor growth), can reduce tumor sizes in patients with bladder cancer
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) |
2.6 | — |
| SECONDARY Disease Control Rate (DCR) |
20.5 | — |
| SECONDARY Duration of Objective Tumor Response (OTR) |
— | — |
| SECONDARY Progression Free Survival (PFS) |
7.3 | — |
| SECONDARY Overall Survival (OS) |
23.1 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed urothelial cancer (cancer of the bladder, renal pelvis, ureter, or urethra).
- Tumor, Node, Metastasis (TNM) Stage IV urothelial cancer that can not be helped by curative surgery and/or curative radiotherapy
- Must have had a maximum of 2 prior chemotherapeutic regimens, one for unremovable and/or metastasized disease, and the other in the adjuvant or neo-adjuvant setting.
- Ambulatory and capable of all selfcare more than 50% of waking hours
Exclusion Criteria
- Prior treatment with investigational or standard anti-cancer agents, including radiotherapy, within 4 weeks prior to first dose of study medication; 6 weeks if prior systemic mitomycin, nitrosourea, or suramin.
- Inadequate bone marrow reserve
- Inadequate liver function in the presence of liver metastases
- Impaired renal function
Data sourced from ClinicalTrials.gov (NCT00661609). 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.