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Spots Global Cancer Trial Database for Study of CPI-100 in Patients With Advanced Tumors

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Trial Identification

Brief Title: Study of CPI-100 in Patients With Advanced Tumors

Official Title: A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of CPI-100 Via Intravenous Infusion in Patients With Advanced Solid Tumors

Study ID: NCT03781362

Conditions

Advanced Tumors

Interventions

CPI-100
Capecitabine

Study Description

Brief Summary: This is a prospective, open-label, 2-arm, non-randomized study of CPI-100 in patients with advanced tumors. CPI-100 is administered via intravenous infusion in a 3 + 3 study design to identify the maximum tolerated dose (MTD).

Detailed Description: Primary Objectives: • To determine the safety, tolerability and maximum tolerated dose (MTD) of CPI-100 as once every two weeks (Q2W) and once every three weeks (Q3W) regimens in patients with advanced tumors Secondary Objectives: * To evaluate the pharmacokinetics (PK) of CPI-100 * To evaluate clinical response and resolution of symptoms after CPI-100 treatment * To characterize adverse events of CPI-100 monotherapy and CPI-100 in combination with capecitabine in patients with advanced cancers Up to 5 dose levels of CPI-100 Q2W, 4 dose levels of Q3W regimen of CPI-100 monotherapy (Q3W Arm A) and 4 dose levels of Q3W regimen of CPI-100 in combination with capecitabine (Q3W Arm B) will be tested in a dose escalation study. MTD will be defined as the dose associated with a dose limiting toxicity (DLT) in less than or equal to 33% of patients at the dose level tested. Dose limiting toxicity (DLT) is defined as one of the following events occurring from the intravenous injection of CPI-100 within 28 days (Q2W) or 42 days (Q3W): * Grade 4 or greater treatment related adverse events * Any Grade 3 or greater treatment related non-hematologic, non-dermatologic toxicity (including nausea, vomiting or diarrhea lasting more than 72 hours)

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

South Texas Accelerated Research Therapeutics, Grand Rapids, Michigan, United States

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States

South Texas Accelerated Research Therapeutics, San Antonio, Texas, United States

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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