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CHR-2797

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |United Therapeutics Corporation|Last Updated: Aug 6, 2010

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00692354Safety Study to Evaluate CHR-2797 in Patients With Advanced TumoursPHASE1 COMPLETED 41Oct 1, 2004Mar 1, 2008Aug 6, 2010 -
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Study Endpoints
Primary Endpoints
To determine the safety, tolerability, dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of CHR-2797 when administered orally, once daily, to patients with advanced solid tumours.
3 years
Secondary Endpoints
To determine the PK parameters for oral CHR-2797 at increasing dose levels;
3 years
To investigate the PD effects of CHR-2797 in blood and tumour cells
3 years
To enable a preliminary assessment of anti-tumour activity of CHR-2797
3 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
CHR-2797 (tosedostat)DRUGDrug was given orally, once daily, ensuring a dosing interval of approximately 24 hours. Dose escalations took place starting at 10mg and escalating (per protocol) as follows: 20, 40, 90, 130, 180, 240 and 320 mg
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Signed, informed consent * Histological or cytologically confirmed malignant solid tumour refractory to standard therapy or for which no standard therapy exists * Evaluable disease * Recovered from the acute adverse effects of prior therapies (excluding alopecia and grade 1 ne...

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