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A Study Evaluating STA-9090 in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01039519
Recruitment Status : Completed
First Posted : December 25, 2009
Results First Posted : March 10, 2016
Last Update Posted : March 10, 2016
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gastrointestinal Stromal Tumor
Intervention Drug: Ganetespib
Enrollment 27
Recruitment Details  
Pre-assignment Details Thirty-one patients were screened; 4 of the 31 were screen failures.
Arm/Group Title Ganetespib 200 mg/m^2
Hide Arm/Group Description Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
Period Title: Treatment
Started 27
Completed 0 [1]
Not Completed 27
Reason Not Completed
Progressive disease             20
Treatment failure             2
Adverse Event             3
Physician Decision             2
[1]
Reason not completed represents reason for terminating treatment.
Period Title: Survival Follow-up
Started 27
Completed 0
Not Completed 27
Reason Not Completed
Death             23
Sponsor decision             4
Arm/Group Title Ganetespib 200 mg/m^2
Hide Arm/Group Description Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
Full analysis set, which includes participants given at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
54.4  (8.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
12
  44.4%
Male
15
  55.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
27
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
  14.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   7.4%
White
21
  77.8%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 27 participants
74.94  (22.095)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 27 participants
171.57  (10.295)
Body Surface Area (BSA)  
Mean (Standard Deviation)
Unit of measure:  M^2
Number Analyzed 27 participants
1.863  (0.2909)
Time from Initial Gastrointestinal Stromal Tumor (GIST) Diagnosis to Consent   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 27 participants
68.71  (34.699)
[1]
Measure Description: N = 25 participants
Time from Metastatic/Unresectable GIST Diagnosis to Consent   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 27 participants
46.77  (28.606)
[1]
Measure Description: N = 20 participants GIST = gastrointestinal stromal tumor
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants
0 14
1 13
[1]
Measure Description:

The ECOG scale is as follows:

  • Grade 0: Fully active, able to carry on all pre-disease activities without restriction;
  • Grade 1: Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature;
  • Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours;
  • Grade 3: Capable of only limited self-care, confined to bed or chair > 50% of waking hours;
  • Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or Chair.
Any Prior Exposure to Heat Shock Protein 90 (HSP90) Inhibitors  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants
Yes 5
No 21
Unknown 1
Prior Systemic Treatment for GIST  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants
Yes 27
No 0
Number of Prior Systemic Treatment Regimens for GIST  
Mean (Standard Deviation)
Unit of measure:  Regimens
Number Analyzed 27 participants
5.85  (2.476)
Best Response From Prior Systemic Treatment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants
Complete response 3
Partial response 6
Stable Disease 17
Progressive disease 1
Unknown 0
[1]
Measure Description:

Target Lesion Response Criteria, RECIST (version 1.0)

  • Complete response - disappearance of all target lesions
  • Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions
  • Stable disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease
  • Progressive disease - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions
1.Primary Outcome
Title Percentage of Participants Showing Clinical Benefit Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0
Hide Description

Clinical benefit is defined as showing a complete response (CR), a partial response (PR) or stable disease (SD) for at least 16 weeks.

  • CR: disappearance of all target lesions and non-target lesions and no new lesions
  • PR: at least a 30% decrease in the sum of the longest diameter of target lesions, no disease progression for non-target lesions, and no new lesions
  • SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, no disease progression for non-target lesions, and no new lesions
Time Frame Week 16 up to Week 47
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set which included participants receiving at least one dose of study medication.
Arm/Group Title Ganetespib 200 mg/m^2
Hide Arm/Group Description:
Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: percentage of participants
18.5
2.Secondary Outcome
Title Percentage of Participants Showing an Objective Response Based on RECIST Version 1.0
Hide Description

Objective response included participants whose best response with confirmation was a complete response (CR) or partial response (PR) from first dose until progression or end of study.

  • CR: disappearance of all target lesions and non-target lesions and no new lesions
  • PR: at least a 30% decrease in the sum of the longest diameter of target lesions, no disease progression for non-target lesions, and no new lesions
Time Frame Week 16 up to Week 47
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Ganetespib 200 mg/m^2
Hide Arm/Group Description:
Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: percentage of participants
0
3.Secondary Outcome
Title Kaplan-Meier Estimate of Progression Free Survival (PFS)
Hide Description

PFS was defined as the time from the baseline CT scan to disease progression per RECIST or death for any cause. Progressive disease (PD) was defined as

  • at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or
  • the appearance of 1 or more new lesions or
  • the unequivocal progression of existing nontarget lesions
Time Frame Day 1 up to Week 47
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Ganetespib 200 mg/m^2
Hide Arm/Group Description:
Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 27
Median (95% Confidence Interval)
Unit of Measure: months
1.8
(1.6 to 3.5)
4.Secondary Outcome
Title Kaplan-Meier Estimate of Overall Survival
Hide Description Overall survival was defined as the time from first dose to death or the date last known alive.
Time Frame Day 1 up to week 97
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Ganetespib 200 mg/m^2
Hide Arm/Group Description:
Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 27
Median (95% Confidence Interval)
Unit of Measure: months
10.3
(5.8 to 13.6)
5.Secondary Outcome
Title Percentage of Participants Showing a Tumor Response During Cycle 1 in Selected Participants Measured by Positron Emission Tomography (PET)
Hide Description PET imaging was completed on selected patients only from one investigative site. Treatment phase PET and biopsy was completed on any day from Cycle 1 Day 2 through Day 10. PET imaging data were analyzed utilizing the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group guidelines [Young H, Eur J Cancer, 1999]. Tumor response was considered a complete response (CR) or a partial response (PR).
Time Frame Day 2 to Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from one investigative site who provided consent for the PET/CT imaging.
Arm/Group Title Ganetespib 200 mg/m^2
Hide Arm/Group Description:
Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of participants
66.7
6.Secondary Outcome
Title Count of Participants With Treatment-Emergent Adverse Events (AEs)
Hide Description

Treatment-emergent AEs were defined as AEs that occurred from the time of first dose through 30 days after the last dose of study medication. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria:

Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death

A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event.

Dose modification includes dose delay and dose reduction.

Time Frame Day 1 up to Week 51
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Ganetespib 200 mg/m^2
Hide Arm/Group Description:
Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: participants
>=1 AE 27
>=1 AE with severity grade >=3 15
>= 1 SAE 10
>=1 AE leading to dose modification 10
>=1 AE leading to dose interruption 1
>=1 AE leading to study drug discontinuation 3
>=1 AE with an outcome of death 1
Time Frame Day 1 up to Week 51
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ganetespib 200 mg/m^2
Hide Arm/Group Description Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
All-Cause Mortality
Ganetespib 200 mg/m^2
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Ganetespib 200 mg/m^2
Affected / at Risk (%)
Total   10/27 (37.04%) 
Blood and lymphatic system disorders   
Anaemia  1  2/27 (7.41%) 
Gastrointestinal disorders   
Abdominal pain  1  2/27 (7.41%) 
Colonic fistula  1  1/27 (3.70%) 
Gastrointestinal haemorrhage  1  1/27 (3.70%) 
Intussusception  1  1/27 (3.70%) 
Nausea  1  1/27 (3.70%) 
Oesophageal ulcer  1  1/27 (3.70%) 
Vomiting  1  1/27 (3.70%) 
Hepatobiliary disorders   
Hepatic pain  1  1/27 (3.70%) 
Infections and infestations   
Infection  1  1/27 (3.70%) 
Investigations   
Amylase increased  1  1/27 (3.70%) 
Blood bilirubin increased  1  1/27 (3.70%) 
Lipase increased  1  1/27 (3.70%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasm progression  1  1/27 (3.70%) 
Psychiatric disorders   
Confusional state  1  1/27 (3.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ganetespib 200 mg/m^2
Affected / at Risk (%)
Total   27/27 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  9/27 (33.33%) 
Lymphopenia  1  2/27 (7.41%) 
Leukopenia  1  1/27 (3.70%) 
Neutropenia  1  1/27 (3.70%) 
Cardiac disorders   
Tachycardia  1  3/27 (11.11%) 
Arrhythmia superventribular  1  1/27 (3.70%) 
Ear and labyrinth disorders   
Ear discomfort  1  1/27 (3.70%) 
Eye disorders   
Eye pain  1  1/27 (3.70%) 
Vision blurred  1  1/27 (3.70%) 
Gastrointestinal disorders   
Diarrhoea  1  22/27 (81.48%) 
Nausea  1  13/27 (48.15%) 
Vomiting  1  10/27 (37.04%) 
Constipation  1  7/27 (25.93%) 
Abdominal distension  1  6/27 (22.22%) 
Abdominal pain  1  5/27 (18.52%) 
Abdominal discomfort  1  4/27 (14.81%) 
Abdominal pain lower  1  4/27 (14.81%) 
Abdominal pain upper  1  2/27 (7.41%) 
Abdominal tenderness  1  2/27 (7.41%) 
Dyspepsia  1  2/27 (7.41%) 
Rectal haemorrhage  1  2/27 (7.41%) 
Retching  1  2/27 (7.41%) 
Anal fissure  1  1/27 (3.70%) 
Ascites  1  1/27 (3.70%) 
Frequent bowel movements  1  1/27 (3.70%) 
Haematochezia  1  1/27 (3.70%) 
Haemorrhoidal haemorrhage  1  1/27 (3.70%) 
Haemorrhoids  1  1/27 (3.70%) 
Proctalgia  1  1/27 (3.70%) 
Small intestinal obstruction  1  1/27 (3.70%) 
Stomatitis  1  1/27 (3.70%) 
General disorders   
Fatigue  1  15/27 (55.56%) 
Asthenia  1  2/27 (7.41%) 
Malaise  1  2/27 (7.41%) 
Pyrexia  1  2/27 (7.41%) 
Chest pain  1  1/27 (3.70%) 
Chills  1  1/27 (3.70%) 
Early satiety  1  1/27 (3.70%) 
Feeling jittery  1  1/27 (3.70%) 
Influenza like illness  1  1/27 (3.70%) 
Localised oedema  1  1/27 (3.70%) 
Oedema  1  1/27 (3.70%) 
Infections and infestations   
Bronchitis  1  1/27 (3.70%) 
Candidiasis  1  1/27 (3.70%) 
Ear infection  1  1/27 (3.70%) 
Eye infection bacterial  1  1/27 (3.70%) 
Fungal skin infection  1  1/27 (3.70%) 
Gastroenteritis viral  1  1/27 (3.70%) 
Labyrinthitis  1  1/27 (3.70%) 
Pharyngitis streptococcal  1  1/27 (3.70%) 
Sinusitis  1  1/27 (3.70%) 
Upper respiratory tract infection  1  1/27 (3.70%) 
Urinary tract infection  1  1/27 (3.70%) 
Injury, poisoning and procedural complications   
Contusion  1  3/27 (11.11%) 
Infusion related reaction  1  3/27 (11.11%) 
Post procedural haemorrhage  1  2/27 (7.41%) 
Compression fracture  1  1/27 (3.70%) 
Post procedural complication  1  1/27 (3.70%) 
Seroma  1  1/27 (3.70%) 
Thermal burn  1  1/27 (3.70%) 
Investigations   
Blood alkaline phosphatase increased  1  7/27 (25.93%) 
Weight decreased  1  5/27 (18.52%) 
Amylase increased  1  4/27 (14.81%) 
Aspartate aminotransferase increased  1  4/27 (14.81%) 
Lipase increased  1  4/27 (14.81%) 
Activated partial thromboplastin time prolonged  1  2/27 (7.41%) 
Blood creatine phosphokinase increased  1  2/27 (7.41%) 
Alanine aminotransferase increased  1  1/27 (3.70%) 
Blood albumin decreased  1  1/27 (3.70%) 
Blood creatinine increased  1  1/27 (3.70%) 
Blood lactate dehydrogenase increased  1  1/27 (3.70%) 
Blood magnesium decreased  1  1/27 (3.70%) 
Blood phosphorus decreased  1  1/27 (3.70%) 
Blood potassium decreased  1  1/27 (3.70%) 
Electrocardiogram QT prolonged  1  1/27 (3.70%) 
Hypertriglyceridaemia  1  1/27 (3.70%) 
Hypocalcaemia  1  1/27 (3.70%) 
Hypomagnesaemia  1  1/27 (3.70%) 
Hypophosphataemia  1  1/27 (3.70%) 
Metabolism and nutrition disorders   
Decreased appetite  1  5/27 (18.52%) 
Hyperglycaemia  1  5/27 (18.52%) 
Dehydration  1  3/27 (11.11%) 
Hyperuricaemia  1  2/27 (7.41%) 
Hypoglycaemia  1  2/27 (7.41%) 
Hypokalaemia  1  2/27 (7.41%) 
Hypercalcaemia  1  1/27 (3.70%) 
Hypercholesterolaemia  1  1/27 (3.70%) 
Hyperkalaemia  1  1/27 (3.70%) 
Hypertriglyceridaemia  1  1/27 (3.70%) 
Hypocalcaemia  1  1/27 (3.70%) 
Hypomagnesaemia  1  1/27 (3.70%) 
Hypophosphataemia  1  1/27 (3.70%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  6/27 (22.22%) 
Back pain  1  6/27 (22.22%) 
Myalgia  1  5/27 (18.52%) 
Pain in extremity  1  2/27 (7.41%) 
Flank pain  1  1/27 (3.70%) 
Musculoskeletal discomfort  1  1/27 (3.70%) 
Musculoskeletal pain  1  1/27 (3.70%) 
Temporomandibular joint syndrome  1  1/27 (3.70%) 
Torticollis  1  1/27 (3.70%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumour pain  1  1/27 (3.70%) 
Nervous system disorders   
Headache  1  10/27 (37.04%) 
Dizziness  1  4/27 (14.81%) 
Presyncope  1  3/27 (11.11%) 
Dysgeusia  1  2/27 (7.41%) 
Peripheral sensory neuropathy  1  2/27 (7.41%) 
Somnolence  1  2/27 (7.41%) 
Paraesthesia  1  1/27 (3.70%) 
Peripheral motor neuropathy  1  1/27 (3.70%) 
Psychiatric disorders   
Insomnia  1  8/27 (29.63%) 
Anxiety  1  2/27 (7.41%) 
Confusional state  1  2/27 (7.41%) 
Nightmare  1  2/27 (7.41%) 
Abnormal dreams  1  1/27 (3.70%) 
Agitation  1  1/27 (3.70%) 
Depressed mood  1  1/27 (3.70%) 
Renal and urinary disorders   
Bladder pain  1  1/27 (3.70%) 
Fanconi syndrome acquired  1  1/27 (3.70%) 
Proteinuria  1  1/27 (3.70%) 
Urinary hesitation  1  1/27 (3.70%) 
Reproductive system and breast disorders   
Polymenorrhoea  1  1/27 (3.70%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  4/27 (14.81%) 
Dyspnoea  1  2/27 (7.41%) 
Dyspnoea exertional  1  2/27 (7.41%) 
Hiccups  1  1/27 (3.70%) 
Increased upper airway secretion  1  1/27 (3.70%) 
Pleural effusion  1  1/27 (3.70%) 
Productive cough  1  1/27 (3.70%) 
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  5/27 (18.52%) 
Eczema  1  2/27 (7.41%) 
Night sweats  1  2/27 (7.41%) 
Dermatitis acneiform  1  1/27 (3.70%) 
Dermatitis contact  1  1/27 (3.70%) 
Exfoliative rash  1  1/27 (3.70%) 
Hair colour changes  1  1/27 (3.70%) 
Nail disorder  1  1/27 (3.70%) 
Onychoclasis  1  1/27 (3.70%) 
Vascular disorders   
Hypertension  1  4/27 (14.81%) 
Deep vein thrombosis  1  1/27 (3.70%) 
Flushing  1  1/27 (3.70%) 
Hot flush  1  1/27 (3.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor has the right, 60 days before submission for publication, to review disclosures and require deletion of its confidential information, excluding the study results. Public disclosure shall be delayed for up to 60 additional days in order for the Sponsor to file a patent application, if needed. Single center publications will be postponed until after disclosure of pooled data (all sites), or, for a period of 18 months from study completion/termination at all participating sites.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: VP Clinical Research
Organization: Synta Pharmaceuticals
Phone: 781-541-7156
EMail: aoneill@syntapharma.com
Layout table for additonal information
Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT01039519    
Other Study ID Numbers: 9090-05
First Submitted: December 23, 2009
First Posted: December 25, 2009
Results First Submitted: February 11, 2016
Results First Posted: March 10, 2016
Last Update Posted: March 10, 2016