NCT00598806

A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 3 Trial of Single-Dose Intravesical Apaziquone (EOquin®) as a Surgical Adjuvant Instilled in the Early Postoperative Period in Patients Undergoing Transurethral Resection for Noninvasive Bladder Cancer (Protocol SPI-612)

Completed Phase 3 Results posted Last updated 10 October 2017

What this trial tests

Phase 3 trial testing Apaziquone in Bladder Cancer in 812 participants. Completed in 1 January 2012.

Timeline

1 August 2007

Primary endpoint
1 January 2012

1 January 2012

Quick facts

Lead sponsor	Spectrum Pharmaceuticals, Inc
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	812
Start date	1 August 2007
Primary completion	1 January 2012
Estimated completion	1 January 2012
Sites	77 locations across United States, Canada, Poland

Drugs / interventions tested

• Apaziquone — full drug profile →
• Placebo
• TURBT

Conditions studied

• Bladder Cancer — all drugs for Bladder Cancer →

Sponsor

Spectrum Pharmaceuticals, Inc — full company profile →

Who can join

18 and older, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Recurrence Rate at 2 Years
  Time frame: 2 years
  The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before year 2.

Sponsor's own description

The purpose of this study was to evaluate the 2-Year Recurrence Rate of bladder cancer in randomized patients with tumor histology Ta, G1-G2 who received TransUrethral Resection of Bladder Tumor (TURBT) plus apaziquone versus those who received TURBT plus placebo.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hypoxia-targeted drug delivery.
   Sharma A, Arambula JF, Koo S, Kumar R, et al · · 2019 · cited 336× · PMID 30575832 · DOI 10.1039/c8cs00304a
2. Targeting hypoxia in the tumor microenvironment: a potential strategy to improve cancer immunotherapy.
   Wang B, Zhao Q, Zhang Y, Liu Z, et al · · 2021 · cited 189× · PMID 33422072 · DOI 10.1186/s13046-020-01820-7
3. Targeting the hypoxic fraction of tumours using hypoxia-activated prodrugs.
   Phillips RM. · · 2016 · cited 155× · PMID 26811177 · DOI 10.1007/s00280-015-2920-7
4. Improving Cancer Immunotherapy by Targeting the Hypoxic Tumor Microenvironment: New Opportunities and Challenges.
   Noman MZ, Hasmim M, Lequeux A, Xiao M, et al · · 2019 · cited 152× · PMID 31540045 · DOI 10.3390/cells8091083
5. Tumor hypoxia: From basic knowledge to therapeutic implications.
   Liao C, Liu X, Zhang C, Zhang Q. · · 2023 · cited 123× · PMID 36603793 · DOI 10.1016/j.semcancer.2022.12.011
6. Molecular Pathways: Hypoxia-Activated Prodrugs in Cancer Therapy.
   Baran N, Konopleva M. · · 2017 · cited 105× · PMID 28137923 · DOI 10.1158/1078-0432.ccr-16-0895
7. Remembering the Host in Tuberculosis Drug Development.
   Frank DJ, Horne DJ, Dutta NK, Shaku MT, et al · · 2019 · cited 34× · PMID 30590592 · DOI 10.1093/infdis/jiy712
8. Summary and Recommendations from the National Cancer Institute's Clinical Trials Planning Meeting on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer.
   Lerner SP, Bajorin DF, Dinney CP, Efstathiou JA, et al · · 2016 · cited 26× · PMID 27376138 · DOI 10.3233/blc-160053