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Protein Kinase Inhibitor
XL888 for Melanoma
Phase 1
Waitlist Available
Led By Zeynep Eroglu, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
AJCC Stage IV (Tany, Nany, M1a, b, or c)
AJCC Stage III B or C with unresectable nodal/locoregional involvement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a new drug, XL888, to see if it is safe and effective when used with the drug vemurafenib.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D)
Secondary outcome measures
Best Overall Response Rate (ORR)
Overall Survival (OS) Rate
Progression Free Survival (PFS) Rate
Side effects data
From 2015 Phase 3 trial • 675 Patients • NCT0100698056%
Arthralgia
48%
Alopecia
47%
Fatigue
43%
Rash
40%
Photosensitivity Reaction
39%
Nausea
37%
Diarrhoea
34%
Headache
29%
Hyperkeratosis
29%
Skin Papilloma
26%
Pruritus
24%
Dry Skin
23%
Decreased Appetite
23%
Pain In Extremity
22%
Vomiting
21%
Pyrexia
20%
Squamous cell carcinoma of skin
18%
Erythema
17%
Sunburn
16%
Dysgeusia
16%
Back Pain
15%
Oedema Peripheral
15%
Constipation
15%
Myalgia
15%
Asthenia
15%
Cough
14%
Seborrhoeic Keratosis
13%
Actinic Keratosis
13%
Musculoskeletal Pain
12%
Melanocytic Naevus
12%
Dizziness
12%
Skin Lesion
11%
Keratoacanthoma
11%
Abdominal Pain Upper
11%
Nasopharyngitis
11%
Insomnia
10%
Blood Alkaline Phosphatase Increased
10%
Weight Decreased
10%
Dyspnoea
10%
Anaemia
10%
Abdominal Pain
10%
Keratosis Pilaris
10%
Palmar-Plantar Erythrodysaesthesia Syndrome
10%
Rash Maculo-Papular
9%
Influenza Like Illness
9%
Pain
9%
Blood Bilirubin Increased
9%
Paraesthesia
8%
Oropharyngeal Pain
8%
Dermal Cyst
8%
Peripheral Swelling
8%
Blood Creatinine Increased
8%
Chest Pain
8%
Alanine Aminotransferase Increased
8%
Folliculitis
7%
Gamma-Glutamyltransferase Increased
7%
Aspartate Aminotransferase Increased
7%
Chills
6%
Dyspepsia
6%
Conjunctivitis
6%
Upper Respiratory Tract Infection
6%
Depression
5%
Dermatitis Acneiform
5%
Abdominal Distension
5%
Influenza
5%
Hyperaesthesia
5%
Skin Exfoliation
5%
Flushing
4%
Acne
3%
Rash erythematous
3%
Basal cell carcinoma
3%
Urinary tract infection
2%
Malignant melanoma
2%
Lower respiratory tract infection
1%
Thrombocytopenia
1%
Pleuritic pain
1%
Dehydration
1%
Seizure
1%
Pulmonary embolism
1%
Uveitis
1%
Abdominal pain
1%
Pancreatitis
1%
Atrial fibrillation
1%
Myocardial infarction
1%
Chest pain
1%
Pneumonia
1%
Blood bilirubin increased
1%
Gamma-glutamyltransferase increased
1%
Acute kidney injury
1%
Pleural effusion
1%
Blood alkaline phosphatase increased
1%
Gastrointestinal haemorrhage
1%
Bowen's disease
1%
Loss of consciousness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vemurafenib
Vemurafenib After Crossover
Dacarbazine
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dose EscalationExperimental Treatment2 Interventions
The treatment period will include dosing (taking a certain amount on a regular schedule) with vemurafenib along with the study drug, XL888. Everyone in the study will receive both drugs, but the XL888 will be given at different doses (different amounts). Everyone in this study will be given vemurafenib at the standard dose (the amount of the drug that is given as standard treatment) of 960 milligrams (mg) twice per day, unless the first people in the study have severe side effects when taking the lowest dose of XL888 along with vemurafenib. If that happens, the next people in the study may be given a lower dose of vemurafenib (720 mg twice per day) along with the lowest dose of XL888.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
XL888
2017
Completed Phase 1
~70
Vemurafenib
2015
Completed Phase 3
~3100
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
537 Previous Clinical Trials
134,970 Total Patients Enrolled
43 Trials studying Melanoma
3,220 Patients Enrolled for Melanoma
ExelixisIndustry Sponsor
116 Previous Clinical Trials
18,065 Total Patients Enrolled
5 Trials studying Melanoma
299 Patients Enrolled for Melanoma
Zeynep Eroglu, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
3 Previous Clinical Trials
66 Total Patients Enrolled
3 Trials studying Melanoma
66 Patients Enrolled for Melanoma
Frequently Asked Questions
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