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CYC065

Phase 1

Cancer | Small molecule | Oncology |Cyclacel Pharmaceuticals, Inc.|Last Updated: May 31, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02552953A Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced CancersPHASE1 COMPLETED 60Sep 28, 2015Aug 25, 2023May 31, 20241 United States
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Study Endpoints
Primary Endpoints
Number of patients who experience dose-limiting toxicities
cycle 1(each cycle is 21 -28 days)
Secondary Endpoints
Plasma concentrations
cycle 1(each cycle is 21 -28 days)
Half-life of CYC065
cycle 1(each cycle is 21 -28 days)
changes in certain protein levels in peripheral white blood cells by western blots
cycle 1(each cycle is 21 -28 days)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CYC065 - 4 hour infusion (Part 1 completed)EXPERIMENTALCYC065 will be administered by 4 -hour infusion every 3 weeks.
CYC065 - 1 hour infusion (Part 2 - ongoing)EXPERIMENTALCYC065 will be administered by 1 - hour infusion on Days 1, 2, 8, and 9 every 3 weeks
CYC065 - Oral (Part 3 - ongoing)EXPERIMENTALCYC065 will be administered orally on Days 1, 2, 8 and 9 every 3 weeks
Interventions
NameTypeDescription
CYC065DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Histologically or cytologically confirmed solid tumors or lymphomas that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective * 18 years or older * ECOG performance status 0-1 * Life expectancy ≥ 3 months ...

Countries:United States
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