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CPI-100 for Tumors
Phase 1
Waitlist Available
Research Sponsored by Coordination Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a negative pregnancy test for females with child bearing age at screening and should not be breast feeding
Have a histologically or cytologically confirmed diagnosis of advanced solid tumor Have advanced or metastatic disease refractory to standard curative or palliative therapy or contraindication to standard therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 4 months
Awards & highlights
Study Summary
This study is evaluating whether CPI-100, a drug which is designed to help the immune system, may help treat patients with advanced tumors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 4 months
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)
Secondary outcome measures
Adverse Effect
Area Under the Curve (AUC)
Clinical Benefit
+1 moreSide effects data
From 2019 Phase 2 trial • 10 Patients • NCT0200088260%
Nausea
50%
Vomiting
50%
Fatigue
50%
Anorexia
50%
Hypokalemia
40%
Urinary tract infection
40%
Diarrhea
40%
Mucositis oral
30%
Insomnia
30%
Palmar-plantar erythrodysesthesia
30%
Rash
20%
AST increased
20%
Seizure
20%
Blurred vision
20%
Falling down
20%
Bilirubin increased
20%
ALT increased
20%
Dehyrdration
20%
Constipation
20%
Hyponatremia
20%
Headache
10%
Facial swelling
10%
Hypertension
10%
Disorder ear
10%
Epilepsy
10%
Knee Pain
10%
Rash erythematous
10%
Anemia
10%
Hypovolemia
10%
Leukopenia
10%
Neutropenia
10%
Disorder eye
10%
Eye floaters
10%
Vision abnormal
10%
Stomatitis
10%
Hand-foot syndrome
10%
Legs restless
10%
Taste alteration
10%
Allergic reaction
10%
Thrush
10%
Creatinine serum increased
10%
Amylase increased
10%
Growth accelerated
10%
Hyperglycemia
10%
Dyspnea
10%
Epistaxis
10%
Colitis
10%
Dysphagia
10%
Weakness generalized
10%
Visual disturbance
10%
Abdominal Pain
10%
Canker sore oral
10%
Cramp abdominal
10%
Dry mouth
10%
Gastritis
10%
Hemorrhoids
10%
Pancreatitis
10%
Spasm oropharyngeal
10%
Hypocalcemia
10%
Lipase increased
10%
Dizziness
10%
Edema cerebral
10%
Neuropathy
10%
Numbness
10%
Somnolence
10%
Tremor
10%
Agitation
10%
Depression
10%
Emotional lability
10%
Incontinence urinary
10%
Renal function abnormal
10%
Potassium deficiency
10%
Muscle weakness
10%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
BKM120 Plus Capecitabine
Trial Design
2Treatment groups
Experimental Treatment
Group I: CPI-100 MonotherapyExperimental Treatment1 Intervention
Dose Escalation Groups:
CPI-100 will be administered via intravenous infusion once every 2 weeks (Q2W) for up to 5 dose levels and once every 3 weeks (Q3W Arm A) for up to 4 dose levels in a 3 + 3 dose escalation study
Dose Expansion Group: Maximum tolerated dose or the recommended Phase 2 dose (RP2D) from dose escalation group
Group II: CPI-100 Combination with CapecitabineExperimental Treatment2 Interventions
CPI-100 will be administered via intravenous infusion once every 3 weeks in combination with oral capecitabine for up to 4 dose levels in a dose escalation study (Q3W Arm B)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CPI-100
2018
Completed Phase 1
~40
Capecitabine
2013
Completed Phase 3
~3420
Find a Location
Who is running the clinical trial?
Coordination Pharmaceuticals, Inc.Lead Sponsor
5 Previous Clinical Trials
92 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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