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CAL-101

Phase 1

Chronic Lymphocytic Leukemia (CLL) | Small molecule | Oncology |Gilead Sciences, Inc.|Last Updated: Aug 31, 2012

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 Enrollment192
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00710528Dose Escalation Study of CAL-101 in Select Relapsed or Refractory Hematologic MalignanciesPHASE1 COMPLETED 192 — — Jun 1, 2008Aug 1, 2012Aug 31, 20129 United States
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Study Endpoints
Primary Endpoints
To evaluate the safety of CAL-101 and determine the dose limiting toxicity in patients with hematologic malignancies.
28 days
Secondary Endpoints
To evaluate the pharmacokinetic parameters, pharmacodynamic effects and clinical response rate following CAL-101 treatment in patients with hematologic malignancies.
28 Days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
one armEXPERIMENTAL -
Interventions
NameTypeDescription
CAL-101DRUGCAL-101 50, 100, 150, 200, 350 mg capsules BID for 28 days CAL-101 150, 300 mg QD for 28 days CAL-101 150 mg BID 3 weeks on 1 week off for 28 days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: 1. Age \> or = 18. 2. Has relapsed or refractory disease as defined by the following: * CLL - refractory to or relapsed after at least 2 prior therapies, including fludarabine, alone or in combination. Patients should not be eligible for transplantation (patients who are can...

Countries:United States
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