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Oxidative Phosphorylation Inhibitor IACS-010759 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Phase 1 trial testing Oxidative Phosphorylation Inhibitor IACS-010759 in Recurrent Acute Myeloid Leukemia in 17 participants. Terminated before completion.
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 17 |
| Start date | 29 September 2016 |
| Primary completion | 15 April 2022 |
| Estimated completion | 15 April 2022 |
| Sites | 1 location across United States |
M.D. Anderson Cancer Center — full company profile →
18 and older, any sex, with Recurrent Acute Myeloid Leukemia or Refractory 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.
Will be assessed according to National Cancer Institute Common Toxicity Criteria version 4.03.
| Group | Value | 95% CI |
|---|---|---|
| Phase I (Cohorts 1-4) | NA |
Response is Complete Response (CR) + Complete Response with Incomplete Blood Count Recovery (CRi) + Partial Response (PR) + Morphologic Leukemia -Free State (MLFS): CR is Bone marrow blasts \< 5%; absence of circulating blasts and blasts with Auer rods; absence of extra-medullary disease; ANC \> 1.0 x 10\^9/L; platelet count \>/= 100 x 10\^9/L. CRi is CR except for ANC \</= 1.0 x 10\^9 or platelet count , 100 x 10\^9/L. PR is decreased bone marrow blast % by at least 50% to a value of 5% to 25% and ANC \>/= 1.0 x 10\^9/L; platelet count \>/= 100 x 10\^9/L. MLFS is Bone marrow blasts \< 5%; abc
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 1 | 0 | |
| Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 2 | 0 | |
| Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 3 | 0 | |
| Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 4 | 0 |
Duration of Response: length of time from the first objective evidence of response to the first objective evidence of disease progression.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 1 | NA | NA – NA |
| Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 2 | NA | NA – NA |
| Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 3 | NA | NA – NA |
| Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 4 | NA | NA – NA |
Progression-Free Survival: length of time (up to 5 years) from the date of first treatment to the first objective evidence of disease progression or death, whichever is earlier.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 1 | 1.3 | 0.9 – 1.8 |
| Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 2 | 1.5 | 1.5 – 1.7 |
| Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 3 | 1.4 | 1.1 – 2.8 |
| Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 4 | 0.5 | 0.3 – 1.2 |
Overall Survival: length of time from the date of first administration of study drug to the date of death from any cause.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 1 | NA | NA – NA |
| Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 2 | 5.6 | 2.2 – 8.4 |
| Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 3 | 2.2 | 1.9 – 9.2 |
| Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 4 | 1.6 | 0.4 – 2.6 |
Time frame: Up to 5 years, 6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment (Oxidative Phosp… | Treatment (Oxidative Phosp… | Treatment (Oxidative Phosp… | Treatment (Oxidative Phosp… |
|---|---|---|---|---|---|
| Infection | Infections and infestations | — | — | — | — |
| Hemorrhage/Bleeding-Other (Specify) | General disorders | — | — | — | — |
| Acidosis (metabolic or respiratory) | Metabolism and nutrition disorders | — | — | — | — |
| Neurology | Nervous system disorders | — | — | — | — |
| Neuropathy | Nervous system disorders | — | — | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Syndromes | General disorders | — | — | — | — |
| Reaction | System | Treatment (Oxidative Phosp… | Treatment (Oxidative Phosp… | Treatment (Oxidative Phosp… | Treatment (Oxidative Phosp… |
|---|---|---|---|---|---|
| Metabolic/Laboratory-Othe | Metabolism and nutrition disorders | — | — | — | — |
| Acidosis | Metabolism and nutrition disorders | — | — | — | — |
| Cardiac Arrhythmia | Cardiac disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — |
| Hemorrhage, pulmonary/upper respiratory | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Pain-Other | General disorders | — | — | — | — |
| Rash/desquamation | Skin and subcutaneous tissue disorders | — | — | — | — |
| Hypoalbumineia | Metabolism and nutrition disorders | — | — | — | — |
| hypercalcemia | Metabolism and nutrition disorders | — | — | — | — |
| hypocalcemia | Metabolism and nutrition disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Constitutional Symptoms | General disorders | — | — | — | — |
| Creatinine | Investigations | — | — | — | — |
| Distension/bloating, abdominal | Gastrointestinal disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| xerostomia | Gastrointestinal disorders | — | — | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Edema | General disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Fistula, pulmonary/upper respiratory | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — |
| Infection | Infections and infestations | — | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — | — |
| Magnesium | Metabolism and nutrition disorders | — | — | — | — |
| Muscle weakness, generalized | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Musculoskeletal/Soft Tissue-Other | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Neurology-Other | Nervous system disorders | — | — | — | — |
| Neuropathy: motor | Nervous system disorders | — | — | — | — |
| Neuropathy: sensory | Nervous system disorders | — | — | — | — |
| Ocular/Visual-Other | Eye disorders | — | — | — | — |
| hypophosphatemia | Metabolism and nutrition disorders | — | — | — | — |
| Pruritus/itching | Skin and subcutaneous tissue disorders | — | — | — | — |
| Pulmonary/Upper Respiratory-Other | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Seizure | Nervous system disorders | — | — | — | — |
| Syncope | Nervous system disorders | — | — | — | — |
| Syndromes-Other | General disorders | — | — | — | — |
Most-reported serious reactions: Infection, Hemorrhage/Bleeding-Other (Specify), Acidosis (metabolic or respiratory), Neurology, Neuropathy, Pleural effusion, Syndromes.
Data from ClinicalTrials.gov NCT02882321 adverse events section.
This phase I trial studies the side effects and best dose of oxidative phosphorylation inhibitor IACS-010759 in treating patients with acute myeloid leukemia that has come back or does not respond to treatment. Oxidative phosphorylation inhibitor IACS-010759 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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