Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01688999 · ClinicalTrials.gov registry record · Phase 2
Cabozantinib for Advanced Urothelial Cancer
A Phase 2 study of Urothelial Carcinoma and Urinary Bladder Neoplasms, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
- 1
- Study location
NCT01688999: Completed Phase 2 study of Urothelial Carcinoma and Urinary Bladder Neoplasms, sponsored by National Cancer Institute (NCI).
NCT01688999 is a Phase 2 study of Urothelial Carcinoma and Urinary Bladder Neoplasms that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 69 participants, below the 238-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01688999, a Phase 2 study of Urothelial Carcinoma and Urinary Bladder Neoplasms, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Cabozantinib is a drug that slows the growth of blood vessels that feed tumors. It is approved for medullary thyroid cancer. However, studies have shown that prostate and ovarian tumors respond to it. Researchers want see if cabozantinib can be a safe and effective treatment for urothelial cancer. Objectives: \- To test the safety and effectiveness of cabozantinib for advanced urothelial cancer. Eligibility: \- Individuals at least 18 years of age who have advanced urothelial cancer that has not responded to standard treatments. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Tumor tissue samples will also be collected. Imaging studies will also be performed. * Participants will take cabozantinib by mouth once per day on each day of a 28-day cycle. * Treatment will be monitored with frequent blood tests and imaging studies. * Participants will continue to take the study drug for as long as their cancer does not worsen and side effects are not too severe.
Primary Outcome
Complete Response (CR) or Partial Response (PR) to Cabozantinib (XL184) assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Conditions Studied
Interventions
- DRUG Cabozantinib
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2012-09-11 |
| Est. Completion | 2020-09-14 |
| Phase | Phase 2 |
What the finished NCT01688999 record still lists
NCT01688999 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 238-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (71% lower).
The record links to 4 conditions, with Urothelial Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which Cabozantinib is the first listed.
NCT01688999 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01688999 about?
NCT01688999 is a clinical study titled "Cabozantinib for Advanced Urothelial Cancer". Background: \- Cabozantinib is a drug that slows the growth of blood vessels that feed tumors. It is approved for medullary thyroid cancer. However, studies have shown that prostate and ovarian tumors respond to it. Researchers want see if cabozantinib can be a safe and effective treatment for urot...
What is the current status of trial NCT01688999?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2012-09-11. Estimated completion is 2020-09-14.
What conditions does trial NCT01688999 study?
This clinical trial studies the following conditions: Urothelial Carcinoma, Urinary Bladder Neoplasms, Kidney Neoplasms, Urethral Neoplasms.
What interventions are being tested in trial NCT01688999?
The interventions under investigation include: Cabozantinib (DRUG).
Who is sponsoring clinical trial NCT01688999?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01688999 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Urothelial Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01688999's enrollment target sits among peer trials
69 45th of 85 higher than 41 of 85 other Urothelial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urothelial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer
RECRUITING · Phase 2
-
Circulating Tumor DNA Response In Urothelial Cancer
RECRUITING · Phase 2
-
A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2
RECRUITING · Phase 2
-
Adjuvant Sacituzumab Govitecan and Nivolumab in Muscle-Invasive Urothelial Carcinoma At High-Risk Recurrence
RECRUITING · Phase 2
-
A Study of Enfortumab Vedotin in People With Urothelial Carcinoma of the Upper Urinary Tract
RECRUITING · Phase 2
-
Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04020575 · 69 participants · Phase 1
Autologous huMNC2-CAR44 or huMNC2-CAR22 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*)
- NCT04163614 · 69 participants · NA
Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients
- NCT04164641 · 69 participants · NA
Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic Gait Correction in Reducing Diabetic Foot Ulceration Or Subsequent Amputation in Patients With a History of a Diabetic Foot Ulceration
- NCT04493372 · 69 participants · NA
Deciphering Preserved Autonomic Function After Spinal Cord Injury
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI