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Everolimus (RAD001) in Metastatic Transitional Cell Carcinoma of the Urothelium
Phase 2 trial testing Everolimus in Bladder Cancer in 46 participants. Completed in 15 December 2021.
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 5 December 2008 |
| Primary completion | 15 December 2021 |
| Estimated completion | 15 December 2021 |
| Sites | 1 location across United States |
Memorial Sloan Kettering Cancer Center — full company profile →
18 and older, any sex, with Bladder Cancer or Metastatic Transitional Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To measure the two-month PFS rate of Everolimus (RAD001) as determined by RECIST. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
| Group | Value | 95% CI |
|---|---|---|
| Everolimus | 23 | |
| Everolimus | 22 |
To determine the safety and toxicity of Everolimus (RAD001) in this patient population with toxicities being evaluated by CTCAE v3.0
| Group | Value | 95% CI |
|---|---|---|
| Everolimus | 46 |
To determine the response rate of Everolimus in patients with progressive urothelial cancer who have received prior cytotoxic chemotherapy using the Response Evaluation Criteria in Solid Tumors (version 1.0). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Group | Value | 95% CI |
|---|---|---|
| Everolimus | 2 | |
| Everolimus | 43 |
To assess markers for activated mTOR pathway (including phospho-S6 and phospho-4E BP1) in all pre-treatment tissue specimens and correlate with response to treatment and PFS.
| Group | Value | 95% CI |
|---|---|---|
| Everolimus | 0.62 |
Time frame: 25 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Everolimus |
|---|---|---|
| Death not assoc w CTCAE term-Disease prog NOS | General disorders | — |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | — |
| Confusion | Psychiatric disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Fatigue (asthenia, lethargy, malaise) | General disorders | — |
| Fever (in the absence of neutropenia) | General disorders | — |
| Inf unknown ANC-Joint | Infections and infestations | — |
| Inf unknown ANC-UTI NOS | Infections and infestations | — |
| Nausea | Gastrointestinal disorders | — |
| Renal failure | Renal and urinary disorders | — |
| Thrombosis/thrombus/embolism | Vascular disorders | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Atrial tachycardia/Paroxysmal Atrial Tachycardia | Cardiac disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Edema: limb | General disorders | — |
| Enteritis (inflamm of small bowel) | Gastrointestinal disorders | — |
| Fistula, GI- Rectum | Gastrointestinal disorders | — |
| Fracture | Injury, poisoning and procedural complications | — |
| Hemorrhage, Duodenum | Gastrointestinal disorders | — |
| Hemorrhage, Urinary NOS | Renal and urinary disorders | — |
| Inf norm ANC/gr1/2 neut-Anal/perianal | Infections and infestations | — |
| Inf norm ANC/gr1/2 neut-Blood | Infections and infestations | — |
| Inf norm ANC/gr1/2 neut-Bronchitis NOS | Infections and infestations | — |
| Inf norm ANC/gr1/2 neut-Urinary(bladder) | Infections and infestations | — |
| Inf unknown ANC-Bladder(urinary) | Infections and infestations | — |
| Reaction | System | Everolimus |
|---|---|---|
| Fatigue | General disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Weight loss | Investigations | — |
| Hypercholesterolemia | Investigations | — |
| Hypertriglyceridemia | Metabolism and nutrition disorders | — |
| Elevated Aspartate aminotransferase | Investigations | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Elevated creatinine | Investigations | — |
| Mucositis | Gastrointestinal disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Elevated alanine aminotransferase | Investigations | — |
| Constipation | Gastrointestinal disorders | — |
| Neuropathy | Nervous system disorders | — |
| Thrombocytopenia | Investigations | — |
| Edema | General disorders | — |
| INR abnormal | Investigations | — |
| Hyperphosphatemia | Metabolism and nutrition disorders | — |
| Urinary frequency | Renal and urinary disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| PTT abnormal | Investigations | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Fever | General disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Hypernatremia | Metabolism and nutrition disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Hyperkalemia | Metabolism and nutrition disorders | — |
| Pain | General disorders | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — |
| Dysgeusia | Nervous system disorders | — |
Most-reported serious reactions: Death not assoc w CTCAE term-Disease prog NOS, Dyspnea (shortness of breath), Confusion, Dehydration, Fatigue (asthenia, lethargy, malaise), Fever (in the absence of neutropenia), Inf unknown ANC-Joint, Inf unknown ANC-UTI NOS.
Data from ClinicalTrials.gov NCT00805129 adverse events section.
The purpose of this study is to learn what effects, good and/or bad, Everolimus has on advanced urothelial cancer. The goal of this clinical research study is to learn if the study drug Everolimus can shrink or slow the growth of urothelial cancer. The safety of this drug will also be studied. The patients physical state, changes in the size of the tumor, and laboratory findings taken while on-study will help us decide if Everolimus is safe and effective.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing