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sapacitabine and seliciclib

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Cyclacel Pharmaceuticals, Inc.|Last Updated: Dec 22, 2021

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment103
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00999401A Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid TumorsPHASE1 COMPLETED 103Apr 1, 2009Aug 13, 2019Dec 22, 20212 United States
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Study Endpoints
Primary Endpoints
maximum tolerated dose
1-3 months

MTD of both sapacitabine and seliciclib administered sequentially in advanced solid tumor patients

Secondary Endpoints
tumor response rate
1-3 months
pharmacodynamic effects in skin and peripheral mononuclear cells
1-3 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
sapacitabine and seliciclibEXPERIMENTALSequential or concomitant administration of sapacitabine and seliciclib
Interventions
NameTypeDescription
sapacitabine and seliciclibDRUGsequential or concomitant administration of sapacitabine and seliciclib
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Incurable advanced solid tumors that are no longer responding to conventional therapy or for which no effective therapy exists; at the RD of Part 1, an extension cohort up to 20 patients with metastatic breast cancer who are known to be BRCA mutation carriers will be enrolled....

Countries:United States
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