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ALK Inhibitor
Crizotinib and Ganetespib (STA-9090) in ALK Positive Lung Cancers
Phase 1
Waitlist Available
Led By Gregrory Riely, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
About 18 patients will take part in the phase 1 portion of the trial. In the beginning of the study, 3 patients will be treated with a low dose of ganetespib (STA-9090) and the standard dose of crizotinib. If this dose does not cause significant side effects, it will be increased as new patients take part in the study. The study will only be open at Memorial Sloan Kettering Cancer Center.
Eligible Conditions
- Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
efficacy
maximum tolerated dose
Secondary study objectives
overall survival (OS)
safety profile
Side effects data
From 2020 Phase 3 trial • 207 Patients • NCT0163900166%
Alanine aminotransferase increased
61%
Diarrhoea
60%
Aspartate aminotransferase increased
59%
Vomiting
54%
Nausea
41%
White blood cell count decreased
40%
Visual impairment
38%
Neutrophil count decreased
36%
Constipation
32%
Cough
28%
Headache
27%
Dizziness
26%
Oedema peripheral
26%
Decreased appetite
25%
Blood albumin decreased
21%
Pain in extremity
21%
Nasopharyngitis
20%
Neutropenia
19%
Anaemia
18%
Pyrexia
18%
Hypoalbuminaemia
17%
Upper respiratory tract infection
15%
Chest pain
15%
Dyspnoea
14%
Disease progression
14%
Blood lactate dehydrogenase increased
13%
Blood creatine phosphokinase increased
13%
Sinus bradycardia
13%
Vision blurred
13%
Gamma-glutamyltransferase increased
13%
Back pain
13%
Insomnia
13%
Protein total decreased
13%
Hypocalcaemia
12%
Rash
12%
Leukopenia
12%
Hypokalaemia
11%
Abdominal distension
10%
Abdominal pain
10%
Blood alkaline phosphatase increased
10%
Pain
10%
Alopecia
9%
Chest discomfort
9%
Blood creatinine increased
9%
Fatigue
9%
Oedema
9%
Hypoaesthesia
8%
Asthenia
8%
Lymphocyte count decreased
8%
Arthralgia
8%
Abdominal pain upper
8%
Platelet count decreased
8%
Hypertension
8%
Haemoptysis
7%
Face oedema
7%
Photopsia
7%
Toothache
7%
Haemoglobin decreased
7%
Paraesthesia
7%
Muscular weakness
6%
Taste disorder
6%
Bradycardia
6%
Pneumonia
6%
Blood creatine phosphokinase MB increased
6%
Hyponatraemia
6%
Hypoproteinaemia
6%
Musculoskeletal pain
6%
Red blood cell count decreased
6%
Productive cough
5%
Blood bilirubin increased
5%
Pruritus
4%
Thrombocytopenia
3%
Pulmonary embolism
2%
Dysphagia
2%
Interstitial lung disease
2%
Death
2%
Pleural effusion
2%
Pneumothorax
1%
Subcutaneous emphysema
1%
Hepatic function abnormal
1%
Abdominal discomfort
1%
Intestinal obstruction
1%
Pancreatitis
1%
Pancreatitis acute
1%
Anaphylactic shock
1%
Impaired healing
1%
Phlebitis
1%
Drug-induced liver injury
1%
Gastrointestinal viral infection
1%
Lower respiratory tract infection
1%
Goitre
1%
Ocular hypertension
1%
Post procedural infection
1%
Deep vein thrombosis
1%
Cellulitis
1%
Hyperuricaemia
1%
Colon adenoma
1%
Adenomyosis
1%
Circulatory collapse
1%
Fracture
1%
Altered state of consciousness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Crizotinib
Chemotherapy
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ganetespib (STA-9090) and crizotinibExperimental Treatment1 Intervention
This protocol is a phase I single arm, open label, single institution study of crizotinib and ganetespib (STA-9090) in patients with ALK+ advanced NSCLC who are crizotinib naïve.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ganetespib
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,977 Previous Clinical Trials
599,715 Total Patients Enrolled
Gregrory Riely, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center