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Everolimus in Patients With Advanced Solid Malignancies With TSC1, TSC2, NF1, NF2, or STK11 Mutations
Phase 2 trial testing Everolimus in Solid Malignancy in 12 participants. Completed in 15 August 2017.
| Lead sponsor | Washington University School of Medicine |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 7 October 2015 |
| Primary completion | 15 August 2017 |
| Estimated completion | 15 August 2017 |
| Sites | 1 location across United States |
Washington University School of Medicine
18 and older, any sex, with Solid Malignancy or Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The primary endpoint will be to describe the response rate using RECIST 1.1. Response rate will be defined as complete response (disappearance of all target lesion) plus partial response (a least a 30% decrease in the sum of diameters of target lesions).
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (Everolimus) | 1 |
-To correlate mutations in the mTOR pathway with therapeutic response with everolimus
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (Everolimus) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (Everolimus) | 1 |
-To investigate the genetic changes associated with disease progression following treatment with everolimus.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (Everolimus) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (Everolimus) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (Everolimus) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (Everolimus) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (Everolimus) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (Everolimus) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (Everolimus) | 1 |
Time frame: From start of treatment through 30 days after completion of treatment (estimated average of 7 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm 1 (Everolimus) |
|---|---|---|
| Pericardial Effusion | Cardiac disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Biliary obstruction | Hepatobiliary disorders | — |
| Blood bilirubin increased | Investigations | — |
| Death NOS | General disorders | — |
| Death due to progressive disease | General disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Flank Pain | Musculoskeletal and connective tissue disorders | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — |
| Portal vein thrombosis | Vascular disorders | — |
| Skin infection | Infections and infestations | — |
| Thromboembolic event | Vascular disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Reaction | System | Arm 1 (Everolimus) |
|---|---|---|
| Lymphocyte count decreased | Investigations | — |
| Anemia | Blood and lymphatic system disorders | — |
| Hypertension | Vascular disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Diarrhea | Gastrointestinal disorders | — |
| Dyspepsia | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Mucositis oral | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Alkaline phosphatase increased | Investigations | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Chills | General disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Platelet count decreased | Investigations | — |
| Atrial fibrillation | Cardiac disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Edema limbs | General disorders | — |
| Fever | General disorders | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — |
| Neutrophil count decreased | Investigations | — |
| Pericardial Effusion | Cardiac disorders | — |
| Rash acneiform | Skin and subcutaneous tissue disorders | — |
| White blood cell decreased | Investigations | — |
| Activated partial thromboplastin time prolonged | Investigations | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Agitation | Psychiatric disorders | — |
| Anxiety | Psychiatric disorders | — |
| Arthritis | Musculoskeletal and connective tissue disorders | — |
| Ascites | Gastrointestinal disorders | — |
| Bruising | Injury, poisoning and procedural complications | — |
| Confusion | Psychiatric disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Creatinine increased | Investigations | — |
| Depression | Psychiatric disorders | — |
| Dizziness | Nervous system disorders | — |
Most-reported serious reactions: Pericardial Effusion, Abdominal pain, Constipation, Hyponatremia, Nausea, Pleural effusion, Back pain, Biliary obstruction.
Data from ClinicalTrials.gov NCT02352844 adverse events section.
The purpose of this research study is to look at participants with solid tumor malignancies and specific mutations respond to treatment with everolimus.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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