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SPI-1620

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

SPI-1620 · 1 trial · 1 indication

Phase 1 1
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 CarcinomaCarcinoma
COMPLETED36 Analytics
PHASE1COMPLETED
A 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 Carcinoma
CarcinomaUnlock trial analytics

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 to 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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Competitive Landscape -Cholangiocarcinoma 58 trials (matched to "Carcinoma")

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Frequently asked questions about SPI-1620

What is SPI-1620 used for?

SPI-1620 is an investigational small molecule being studied for the treatment of carcinoma, specifically in patients with recurrent or progressive carcinoma. It is in Phase 1 clinical development and has not been approved by the FDA.

What does SPI-1620 target?

SPI-1620 is an endothelin B receptor agonist. It works by activating the endothelin B receptor, which is involved in various cellular processes. This mechanism is being explored for its potential anti-cancer effects in patients with carcinoma.

Who makes SPI-1620?

SPI-1620 is being developed by Assertio Holdings, Inc., a company traded on the NASDAQ under the ticker symbol ASRT. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug.

What phase is SPI-1620 in?

SPI-1620 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is no longer in active clinical trials.

What clinical trials is SPI-1620 in?

SPI-1620 has been studied in one clinical trial, identified as NCT00613691. This was a Phase 1, open-label, ascending dose study that evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of SPI-1620 in patients with recurrent or progressive carcinoma. The trial enrolled 36 participants and has been completed.

Is SPI-1620 the same as endothelin B agonist?

SPI-1620 is an endothelin B agonist, meaning it activates the endothelin B receptor. It is a specific investigational drug being developed by Assertio Holdings, Inc. for the treatment of carcinoma. The drug is not known by any other brand names.