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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR VALRUBICIN

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Clinical Trials for Valrubicin

Trial ID Title Status Sponsor Phase Summary
NCT00003129 Chemotherapy in Treating Patients With Early-Stage Bladder Cancer Completed National Cancer Institute (NCI) Phase 2 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating patients with early-stage bladder cancer that has not responded to BCG therapy.
NCT00003129 Chemotherapy in Treating Patients With Early-Stage Bladder Cancer Completed Eastern Cooperative Oncology Group Phase 2 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating patients with early-stage bladder cancer that has not responded to BCG therapy.
NCT00003725 Surgery With or Without Chemotherapy in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer Unknown status Anthra Pharmaceuticals Phase 3 RATIONALE: Transurethral resection is a less invasive type of surgery for bladder cancer and may have fewer side effects and improve recovery. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether transurethral resection plus AD 32 is more effective than transurethral resection alone for bladder cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of transurethral resection surgery followed by AD 32 with that of transurethral resection alone in treating patients who have newly diagnosed or recurrent bladder cancer.
NCT00003759 AD 32 With or Without BCG After Surgery in Treating Patients With Newly Diagnosed or Recurrent Superficial Bladder Cancer Completed Anthra Pharmaceuticals Phase 2 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as BCG use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known whether AD 32 is more effective with or without BCG after surgery for superficial bladder cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of AD 32 with or without BCG after surgery in treating patients who have newly diagnosed or recurrent superficial bladder cancer.
NCT01310803 Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder Terminated Endo Pharmaceuticals Phase 3 This is a Phase 3b open-label, randomized, parallel-arm, multicenter study to evaluate the efficacy and safety of 10 monthly intravesical administrations of maintenance therapy with valrubicin following induction with valrubicin as compared to induction with valrubicin only in subjects with CIS of the bladder. The randomization will be 1:1 and subjects will be stratified by tumor type (CIS plus papillary disease vs. CIS only) and time from last bacillus Calmette-Guerin (BCG) failure (>1 year vs. <1 year).
NCT01316874 Intravesical AD 32 (Valrubicin) in Patients With Carcinoma in Situ (CIS) of the Bladder Who Have Failed or Have Recurrence Following Treatment With Bacillus Calmette-guerin (BCG) Completed Endo Pharmaceuticals Phase 2/Phase 3 This is a Phase II/Phase III study of intravesical AD 32 (valrubicin) in patients with carcinoma in situ (CIS) who have been previously treated with intravesical Bacillus Calmette-Guerin (BCG) for CIS and in whom recurrence or failure has occurred after multiple courses of intravesical treatment.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Valrubicin

Condition Name

Condition Name for Valrubicin
Intervention Trials
Bladder Cancer 4
Carcinoma in Situ 2
Transitional Cell Carcinoma 1
Non-muscle Invasive Bladder Cancer 1
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Condition MeSH

Condition MeSH for Valrubicin
Intervention Trials
Urinary Bladder Neoplasms 5
Carcinoma 3
Carcinoma, Transitional Cell 2
Carcinoma in Situ 2
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Clinical Trial Locations for Valrubicin

Trials by Country

Trials by Country for Valrubicin
Location Trials
United States 62
Canada 1
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Trials by US State

Trials by US State for Valrubicin
Location Trials
Pennsylvania 4
Florida 4
Arizona 3
New Jersey 3
Illinois 3
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Clinical Trial Progress for Valrubicin

Clinical Trial Phase

Clinical Trial Phase for Valrubicin
Clinical Trial Phase Trials
Phase 3 2
Phase 2/Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Valrubicin
Clinical Trial Phase Trials
Completed 4
Unknown status 1
Terminated 1
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Clinical Trial Sponsors for Valrubicin

Sponsor Name

Sponsor Name for Valrubicin
Sponsor Trials
Endo Pharmaceuticals 3
Anthra Pharmaceuticals 2
Eastern Cooperative Oncology Group 1
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Sponsor Type

Sponsor Type for Valrubicin
Sponsor Trials
Industry 5
Other 2
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Fish and Richardson
Dow
Citi
McKinsey
Healthtrust
Chinese Patent Office
Baxter
US Army

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