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SPI-1620

Phase 1

Carcinoma | Small molecule | Oncology |Assertio Holdings, Inc.|Last Updated: Oct 21, 2013

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 Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00613691A Phase I, Open-label, Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Endothelin B Agonist, SPI-1620, in Patients With Recurrent or Progressive CarcinomaPHASE1 COMPLETED 36 — — Jan 1, 2008Dec 1, 2012Oct 21, 20131 United States
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Study Endpoints
Primary Endpoints
To assess the safety and tolerability of SPI-1620 administered to patients with recurrent or progressive carcinoma who have failed all standard therapy.
every three weeks
Secondary Endpoints
To assess the pharmacokinetic and pharmacodynamic profiles of SPI-1620 administered to patients with recurrent or progressive carcinoma who have failed all standard therapy.
one week
To identify the optimum dose of SPI-1620 to be used in future Phase II studies.
every three weeks
To assess the safety and tolerability of doses of docetaxel from 60 mg/m2 to 100 mg/m2 when given following infusion of SPI 1620.
every three weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SPI-1620EXPERIMENTALSPI-1620 an endothelin B agonist
Interventions
NameTypeDescription
SPI-1620DRUGSPI-1620 in escalating doses from 0.5 μg/m2 intravenous over sixty seconds
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: All of the following inclusion criteria must be met prior to participation in this study 1. The patient must sign an informed consent. A signed consent form is required prior to the performance of any protocol-related procedures or assessments. 2. The patient must be \>= 18 yea...

Countries:United States
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