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Phase I/II Study of Combination of Sorafenib, Vorinostat, and Bortezomib for the Treatment of Acute Myeloid Leukemia With Complex- or Poor-risk (Monosomy 5/7) Cytogenetics or FLT3-ITD Positive Genotype
Phase 1, PHASE2 trial testing sorafenib, vorinostat and bortezomib in Acute Myeloid Leukemia in 37 participants. Completed in 13 February 2017.
| Lead sponsor | Hamid Sayar |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 37 |
| Start date | 10 February 2012 |
| Primary completion | 29 August 2016 |
| Estimated completion | 13 February 2017 |
| Sites | 1 location across United States |
Hamid Sayar — full company profile →
18 and older, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The number of patients who had a DLT during the dose finding/confirming portion (Phase I) of the trial for the safety of the combination of sorafenib, vorinostat, and bortezomib.
| Group | Value | 95% CI |
|---|---|---|
| Phase I Dose Escalating | 0 |
Evaluate the overall response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better. The percentage of patients achieving this and the exact 95% confidence interval will be calculated. Responses will be defined using the response criteria determined by the International Working Group for AML.
| Group | Value | 95% CI |
|---|---|---|
| Phase II at MTD | 40.0 | 16.3 – 67.7 |
Will be examined using Kaplan-Meier estimates. Time from date of confirmed complete remission to date of relapse. The observations of patients who died or remained alive and relapse free were censored at date of death or last disease evaluation, respectively.
| Group | Value | 95% CI |
|---|---|---|
| Phase II at MTD | 32 | 22 – 42 |
Number of unique patients who had a treatment-related (possible, probable or definite) adverse events that were graded 3 or higher.
| Group | Value | 95% CI |
|---|---|---|
| Phase II at MTD | 4 |
Time frame: Up to one year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Phase I Dose Escalating | Phase II at MTD |
|---|---|---|---|
| Fever | General disorders | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Sepsis | Infections and infestations | — | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Myocardial infarction | Cardiac disorders | — | — |
| Eye disorders - Other | Eye disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Rectal hemorrhage | Gastrointestinal disorders | — | — |
| Lung infection | Infections and infestations | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — | — |
| Myositis | Musculoskeletal and connective tissue disorders | — | — |
| Syncope | Nervous system disorders | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Phase I Dose Escalating | Phase II at MTD |
|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Mucositis oral | Gastrointestinal disorders | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Fever | General disorders | — | — |
| General disorders and administration site conditions - Other | General disorders | — | — |
| Pain | General disorders | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Fatigue | General disorders | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — |
| Confusion | Psychiatric disorders | — | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — |
| Rash acneiform | Skin and subcutaneous tissue disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Sinus tachycardia | Cardiac disorders | — | — |
| Eye disorders - Other | Eye disorders | — | — |
| Gastroesophageal reflux disease | Gastrointestinal disorders | — | — |
| Gastrointestinal disorders - Other | Gastrointestinal disorders | — | — |
| Edema limbs | General disorders | — | — |
| Localized edema | General disorders | — | — |
| Infections and infestations - Other | Infections and infestations | — | — |
| Sinusitis | Infections and infestations | — | — |
| Acidosis | Metabolism and nutrition disorders | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Bone pain | Musculoskeletal and connective tissue disorders | — | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: Fever, Febrile neutropenia, Diarrhea, Sepsis, Respiratory failure, Myocardial infarction, Eye disorders - Other, Nausea.
Data from ClinicalTrials.gov NCT01534260 adverse events section.
This research is being done because treatment options are very limited and usually unsuccessful for Acute Myeloid Leukemia (AML) in older individuals, or younger people with disease that has relapsed and/or proven resistant to standard therapy. Subjects are invited to participate in this study that will examine the use of three drugs called Sorafenib (Nexavar), Vorinostat (Zolinza) and Bortezomib (Velcade) for treating acute myeloid leukemia.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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