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NCT00942331COMPLETEDanonymous

A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients With Advanced Transitional Cell Carcinoma

Sponsor

Source record

National Cancer Institute (NCI)

Phase

Source record

Phase 3

Modality

AI-normalized

protein therapy

Target

AI-normalized

Vascular Endothelial Growth Factor (VEGF) pathway inhibition via Bevacizumab; Gemcitabine and Cisplatin as chemotherapeutic agents.

Indication / condition

AI-normalized

Advanced Urothelial Carcinoma

Intervention

Source record

Bevacizumab, Cisplatin, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Placebo Administration

Source & freshness

Source record

NCT ID

NCT00942331

Original source

ClinicalTrials.gov

Source last updated

Oct 16, 2023

Ingested at

Jun 16, 2026

Internal sync

Jun 16, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT00942331

Title

A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients With Advanced Transitional Cell Carcinoma

Sponsor

National Cancer Institute (NCI)

Status

COMPLETED

Phase

Phase 3

Condition raw

Advanced Urothelial Carcinoma, Metastatic Bladder Urothelial Carcinoma, Metastatic Prostate Carcinoma, Metastatic Renal Pelvis Urothelial Carcinoma, Metastatic Ureter Urothelial Carcinoma, Metastatic Urethral Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Stage IV Bladder Urothelial Carcinoma AJCC v7, Stage IV Prostate Cancer AJCC v7, Stage IV Renal Pelvis Cancer AJCC v7, Stage IV Ureter Cancer AJCC v7, Stage IV Urethral Cancer AJCC v7, Unresectable Urothelial Carcinoma

Condition normalized

Advanced Urothelial Carcinoma, Metastatic Bladder Urothelial Carcinoma, Metastatic Prostate Carcinoma, Metastatic Renal Pelvis Urothelial Carcinoma, Metastatic Ureter Urothelial Carcinoma, Metastatic Urethral Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Stage IV Bladder Urothelial Carcinoma AJCC v7, Stage IV Prostate Cancer AJCC v7, Stage IV Renal Pelvis Cancer AJCC v7, Stage IV Ureter Cancer AJCC v7, Stage IV Urethral Cancer AJCC v7, Unresectable Urothelial Carcinoma

Modality raw

protein therapy

Modality normalized

protein therapy

Target raw

Vascular Endothelial Growth Factor (VEGF) pathway inhibition via Bevacizumab; Gemcitabine and Cisplatin as chemotherapeutic agents.

Target normalized

Vascular Endothelial Growth Factor (VEGF) pathway inhibition via Bevacizumab; Gemcitabine and Cisplatin as chemotherapeutic agents.

Interventions

Bevacizumab, Cisplatin, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Placebo Administration

Public preview

Source record

The trial, sponsored by the National Cancer Institute, investigates the efficacy of a combination regimen of Gemcitabine, Cisplatin, and Bevacizumab versus a control of Gemcitabine and Cisplatin with placebo in patients with advanced transitional cell carcinoma (TCC). If successful, this combination could enhance treatment options in a market characterized by limited effective therapies for advanced TCC, potentially leading to increased market share for the involved agents. The competitive landscape includes existing therapies such as immune checkpoint inhibitors and other chemotherapeutic regimens. Diligence should focus on the trial's outcome and the potential for regulatory approval, which could influence market dynamics significantly.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients With Advanced Transitional Cell Carcinoma

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 17, 2026

NCT ID

NCT00942331

Status

COMPLETED

Phase

Phase 3

Sponsor

National Cancer Institute (NCI)

Executive brief

Investment-Ready Snapshot

The trial, sponsored by the National Cancer Institute, investigates the efficacy of a combination regimen of Gemcitabine, Cisplatin, and Bevacizumab versus a control of Gemcitabine and Cisplatin with placebo in patients with advanced transitional cell carcinoma (TCC). If successful, this combination could enhance treatment options in a market characterized by limited effective therapies for advanced TCC, potentially leading to increased market share for the involved agents. The competitive landscape includes existing therapies such as immune checkpoint inhibitors and other chemotherapeutic regimens. Diligence should focus on the trial's outcome and the potential for regulatory approval, which could influence market dynamics significantly.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedOct 16, 2023
Internal syncJun 16, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT00942331

Indication

Advanced Urothelial Carcinoma

Modality

protein therapy

Target

Vascular Endothelial Growth Factor (VEGF) pathway inhibition via Bevacizumab; Gemcitabine and Cisplatin as chemotherapeutic agents.

Intervention

Bevacizumab, Cisplatin, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Placebo Administration

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.