Loading
Cancer of the Urethra / Urethral Cancer / Gemcitabine · Phase 1 Trial
ClinicalTrials.gov · August 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed Phase 1 registration record for a three-drug combination (gemcitabine, carboplatin, lenalidomide) in advanced urothelial and other solid tumors. The trial enrolled 18 participants and was powered to identify maximum tolerated dose and dose-limiting toxicity, but efficacy or safety results are not posted in this registry record and cannot be assessed.
Phase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Urethral Neoplasms, Neoplasms, Urethral, Cancer of the Urethra, Urethral Cancer; age from 18 Years. Intervention: Arm 1; Arm 2. n = 18. 1 site: United States.
This is a completed Phase 1 registration record for a three-drug combination (gemcitabine, carboplatin, lenalidomide) in advanced urothelial and other solid tumors. The trial enrolled 18 participants and was powered to identify maximum tolerated dose and dose-limiting toxicity, but efficacy or safety results are not posted in this registry record and cannot be assessed.
No efficacy or safety results posted in this registry record. Dose-limiting toxicity and MTD findings not reported in this registry entry.
This record describes a dose-escalation study but does not report safety or efficacy outcomes. Clinicians cannot use this registry entry to assess tolerability or efficacy of the combination; published results must be sought separately.
Phase 1 dose-escalation trial with completed enrollment but no efficacy or safety results reported in this registry record; evidence of tolerability and MTD cannot be assessed without posted outcomes.
As stated by the source record.
Quoted from the source exactly as published.
This record describes a dose-escalation study but does not report safety or efficacy outcomes. Clinicians cannot use this registry entry to assess tolerability or efficacy of the combination; published results must be sought separately.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT01352962). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: COMPLETED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 18 participants (ACTUAL). Conditions: Urethral Neoplasms, Neoplasms, Urethral, Cancer of the Urethra, Urethral Cancer. Interventions: DRUG: Gemcitabine; DRUG: Carboplatin; DRUG: Lenalidomide. Primary outcome measures: dose limiting toxicity (DLT) , Maximum Tolerated Dose (MTD). Brief summary: Background: \- Gemcitabine and carboplatin are chemotherapy drugs used to treat several types of cancer, including cancer of the pancreas, bladder, ovaries, and lung. Lenalidomide, a drug that prevents the growth of new blood vessels in tumors, has been approved for treatment of certain blood cancers, but it has not yet been approved for use in combination with gemcitabine and carboplatin. Researchers are interested in determining the safest and most effective dose of this combined form of chemotherapy for solid tumors, particularly for urothelial cancer (tumors of the bladder, urethra, ureter, or renal pelvis). Objectives: * To evaluate the safety and effectiveness of combined lenalidomide, gemcitabine, and carboplatin as a treatment for solid tumor cancers. * To evaluate the safety and effectiveness of combined lenalidomide, gemcitabine, and carboplatin as a treatment for urothelial (bladder) cancer. Eligibility: * Individuals at least 18 years of age who have been diagnosed with solid tumors that have not responded to standard treatments. * Individuals at least 18 years of age who have been diagnosed with urothelial cancer that has not responded to standard treatments. Design: * Participants will be screened with a physical examination, medical history, blood tests, and tumor imaging studies. * Participants with urothelial cancer will receive lenalidomide alone for the first 14 days of a 21-day cycle before starting the first full treatment cycle. * All participants will receive gemcitabine on days 1 and 8, and carboplatin on day 1 only, of every 21-day treatment cycle. Lenalidomide will be taken daily at home for the first 14 days of each cycle. Participants will be asked to take aspirin or other medications to prevent the possibility of blood clots. * Participants may receive up to six cycles of treatment with this combination. If after six cycles the cancer has not grown or has shrunk, participants may continue to take lenalidomide alone for an additional 6 months (total of 12 months of therapy) or until the cancer recurs. * Participants will be monitored with blood samples, physical examinations, and tumor imaging studies through the cycles of treatment. * After the end of the last treatment cycle, participants will have followup visits every 3 months for the next 18 months, then every 6 months for another 18 months, and then yearly....
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.