Trial Outcomes & Findings for A Study of the HSP90 Inhibitor AUY922 (NCT NCT01485536)

Last Updated: 2017-01-23

Results Overview

Objective Response defined as Complete (CR) and Partial (PR) Response. Computed tomography (CT) and Positron emission tomography (PET) scans done after every 2 cycles to assess efficacy using Cheson Criteria (2007) which lists CR as disappearance of all evidence of disease, and PR as regression of measurable disease and no new sites.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

56 days

Results posted on

2017-01-23

Participant Flow

Recruitment Period: August 28, 2016 to June 17, 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.

Of 26 participants screened for enrollment, five were not eligible therefore excluded from the study before any treatment assignment.

Participant milestones

Participant milestones
Measure	AUY922 AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
Overall Study STARTED	21
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	AUY922 AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
Overall Study Withdrawal by Subject	3
Overall Study Adverse Event	1

Baseline Characteristics

A Study of the HSP90 Inhibitor AUY922

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AUY922 n=21 Participants AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
Age, Continuous	60 years n=39 Participants
Gender Female	5 Participants n=39 Participants
Gender Male	16 Participants n=39 Participants
Race/Ethnicity, Customized Asian	1 Participants n=39 Participants
Race/Ethnicity, Customized Black	1 Participants n=39 Participants
Race/Ethnicity, Customized Hispanic	13 Participants n=39 Participants
Race/Ethnicity, Customized White	15 Participants n=39 Participants
Region of Enrollment United States	21 participants n=39 Participants
Baseline Lymphoma Diagnosis DLBCL	14 Participants n=39 Participants
Baseline Lymphoma Diagnosis PTCL	6 Participants n=39 Participants
Baseline Lymphoma Diagnosis Unknown	1 Participants n=39 Participants

PRIMARY outcome

Timeframe: 56 days

Population: One participant withdrew therefore was not evaluable for the outcome and is excluded from analysis

Outcome measures

Outcome measures
Measure	AUY922 n=20 Participants AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
Objective Response in Participants With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) and Peripheral T-cell Lymphoma (PTCL) PTCL (N=6)	1 Participants
Objective Response in Participants With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) and Peripheral T-cell Lymphoma (PTCL) DLBCL (N=14)	1 Participants

PRIMARY outcome

Timeframe: Up to 12 cycles or 48 weeks

Population: One participant withdrew therefore was not evaluable for the outcome and is excluded from analysis

Percentage of participants with objective response defined as Complete (CR) and Partial (PR) Response. Computed tomography (CT) and Positron emission tomography (PET) scans done after every 2 cycles to assess efficacy using Cheson Criteria (2007) which lists CR as disappearance of all evidence of disease, and PR as regression of measurable disease and no new sites.

Outcome measures

Outcome measures
Measure	AUY922 n=20 Participants AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
Overall Response Rate (ORR) DLBCL (N=14)	7 percentage of participants
Overall Response Rate (ORR) PTCL (N=6)	17 percentage of participants

Adverse Events

AUY922

Serious events: 4 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AUY922 n=20 participants at risk AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
Gastrointestinal disorders Diarrhea	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Infections and infestations Pneumonia	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Vascular disorders Thrombocytopenia	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Infections and infestations Sepsis	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Gastrointestinal disorders Vomiting/Diarrhea	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).

Other adverse events

Other adverse events
Measure	AUY922 n=20 participants at risk AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
Gastrointestinal disorders Abdominal pain	25.0% 5/20 • Number of events 6 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Investigations Activated partial thromboplastin time prolonged	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Investigations Alanine aminotransferase increased	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Investigations Alkaline phosphatase increased	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Immune system disorders Allergic reaction	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	10.0% 2/20 • Number of events 2 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Blood and lymphatic system disorders Anemia	45.0% 9/20 • Number of events 16 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Metabolism and nutrition disorders Anorexia	10.0% 2/20 • Number of events 3 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Psychiatric disorders Anxiety	15.0% 3/20 • Number of events 3 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Investigations Aspartate aminotransferase increased	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Cardiac disorders Atrial fibrillation	10.0% 2/20 • Number of events 2 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Musculoskeletal and connective tissue disorders Back pain	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Gastrointestinal disorders Bloating	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Investigations Blood bilirubin increased	5.0% 1/20 • Number of events 2 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Eye disorders Blurred vision	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Musculoskeletal and connective tissue disorders Bone pain	10.0% 2/20 • Number of events 2 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Injury, poisoning and procedural complications Bruising	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Musculoskeletal and connective tissue disorders Buttock pain	15.0% 3/20 • Number of events 3 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Cardiac disorders Cardiac disorders - (Other)	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Musculoskeletal and connective tissue disorders Chest wall pain	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
General disorders Chills	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Gastrointestinal disorders Constipation	30.0% 6/20 • Number of events 6 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Respiratory, thoracic and mediastinal disorders Cough	35.0% 7/20 • Number of events 7 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Investigations Creatinine increased	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Metabolism and nutrition disorders Dehydration	15.0% 3/20 • Number of events 4 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Psychiatric disorders Depression	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Gastrointestinal disorders Diarrhea	50.0% 10/20 • Number of events 23 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Nervous system disorders Dizziness	10.0% 2/20 • Number of events 2 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Eye disorders Dry eye	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Gastrointestinal disorders Dry mouth	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Skin and subcutaneous tissue disorders Dry skin	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Gastrointestinal disorders Dysphagia	10.0% 2/20 • Number of events 2 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Respiratory, thoracic and mediastinal disorders Dyspnea	20.0% 4/20 • Number of events 4 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
General disorders Edema limbs	30.0% 6/20 • Number of events 6 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Respiratory, thoracic and mediastinal disorders Epistaxis	10.0% 2/20 • Number of events 2 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Skin and subcutaneous tissue disorders Erythema multiforme	10.0% 2/20 • Number of events 2 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Eye disorders Eye disorders - Impaired vision	35.0% 7/20 • Number of events 13 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Infections and infestations Eye infection	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
General disorders Fatigue	60.0% 12/20 • Number of events 21 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
General disorders Fever	15.0% 3/20 • Number of events 6 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Eye disorders Flashing lights	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Gastrointestinal disorders Flatulence	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Eye disorders Floaters	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Gastrointestinal disorders Gastritis	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Gastrointestinal disorders Gastrointestinal disorders - (Other)	5.0% 1/20 • Number of events 2 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
General disorders General disorders and administration site conditions - (Other)	30.0% 6/20 • Number of events 8 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Musculoskeletal and connective tissue disorders Generalized muscle weakness	25.0% 5/20 • Number of events 7 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Nervous system disorders Headache	20.0% 4/20 • Number of events 4 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Gastrointestinal disorders Hemorrhoids	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Respiratory, thoracic and mediastinal disorders Hiccups	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Respiratory, thoracic and mediastinal disorders Hoarseness	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Metabolism and nutrition disorders Hypercalcemia	10.0% 2/20 • Number of events 2 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Metabolism and nutrition disorders Hyperglycemia	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Metabolism and nutrition disorders Hypermagnesemia	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Metabolism and nutrition disorders Hypoalbuminemia	10.0% 2/20 • Number of events 2 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Metabolism and nutrition disorders Hypocalcemia	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Metabolism and nutrition disorders Hypoglycemia	10.0% 2/20 • Number of events 2 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Metabolism and nutrition disorders Hypokalemia	20.0% 4/20 • Number of events 5 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Metabolism and nutrition disorders Hypomagnesemia	45.0% 9/20 • Number of events 11 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Metabolism and nutrition disorders Hyponatremia	10.0% 2/20 • Number of events 2 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Vascular disorders Hypotension	20.0% 4/20 • Number of events 5 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Infections and infestations Infections and infestations - (Other)	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Psychiatric disorders Insomnia	25.0% 5/20 • Number of events 5 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Investigations Investigations - Neutropenia	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Infections and infestations Lip infection	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Infections and infestations Lung infection	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
General disorders Malaise	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Infections and infestations Mucosal infection	10.0% 2/20 • Number of events 2 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Gastrointestinal disorders Mucositis oral	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Musculoskeletal and connective tissue disorders Myalgia	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Respiratory, thoracic and mediastinal disorders Nasal congestion	15.0% 3/20 • Number of events 3 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
General disorders Nausea	45.0% 9/20 • Number of events 15 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Nervous system disorders Nervous system disorders - Numbness & tingling feet	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Investigations Neutrophil count decreased	25.0% 5/20 • Number of events 10 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Eye disorders Night blindness	10.0% 2/20 • Number of events 2 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Gastrointestinal disorders Oral pain	5.0% 1/20 • Number of events 2 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
General disorders Pain	10.0% 2/20 • Number of events 2 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Musculoskeletal and connective tissue disorders Pain in extremity	35.0% 7/20 • Number of events 7 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Infections and infestations Penile infection	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Nervous system disorders Peripheral sensory neuropathy	25.0% 5/20 • Number of events 7 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Eye disorders Photophobia	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Investigations Platelet count decreased	40.0% 8/20 • Number of events 15 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Respiratory, thoracic and mediastinal disorders Productive cough	25.0% 5/20 • Number of events 5 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Skin and subcutaneous tissue disorders Pruritus	10.0% 2/20 • Number of events 3 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Psychiatric disorders Psychiatric disorders - (Other)	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Skin and subcutaneous tissue disorders Purpura	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Skin and subcutaneous tissue disorders Rash acneiform	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Skin and subcutaneous tissue disorders Rash maculo-papular	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Respiratory, thoracic and mediastinal disorders Respiratory failure	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Pneumonia	10.0% 2/20 • Number of events 2 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Skin and subcutaneous tissue disorders Scalp pain	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Infections and infestations Sepsis	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Respiratory, thoracic and mediastinal disorders Sinus disorder	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Cardiac disorders Sinus tachycardia	15.0% 3/20 • Number of events 3 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Respiratory, thoracic and mediastinal disorders Sinusitis	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Lesions	10.0% 2/20 • Number of events 3 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Social circumstances Social circumstances - Cold Sweat	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Respiratory, thoracic and mediastinal disorders Sore throat	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Surgical and medical procedures Surgical and medical procedures - Dental procedures	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Nervous system disorders Syncope	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Infections and infestations Upper respiratory infection	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Renal and urinary disorders Urinary frequency	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Renal and urinary disorders Urinary tract infection	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Gastrointestinal disorders Vomiting	30.0% 6/20 • Number of events 9 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Eye disorders Watering eyes	5.0% 1/20 • Number of events 1 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Investigations Weight loss	10.0% 2/20 • Number of events 2 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).
Respiratory, thoracic and mediastinal disorders Wheezing	10.0% 2/20 • Number of events 2 • Adverse event data were collected through each four week cycle up to 12 cycles (48 weeks).

Additional Information

Yasuhiro Oki, Associate Professor, Lymphoma/Myeloma

The University of Texas (UT) MD Anderson Cancer Center

Phone: 713-792-7734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place