Description:
This is a prospective, open-label, single arm, non-randomized study of CPI-200 in patients
with advanced tumors. CPI-200 is administered via intravenous infusion using an accelerated
titration method followed by a conventional 3 + 3 study design to identify the maximum
tolerated dose (MTD)
Title
- Brief Title: Study of CPI-200 in Patients With Advanced Tumors
- Official Title: A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of CPI-200 Via Intravenous Infusion in Patients With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
CPI-200CL01
- NCT ID:
NCT03953742
Conditions
Interventions
Drug | Synonyms | Arms |
---|
CPI-200 | | CPI-200 |
Purpose
This is a prospective, open-label, single arm, non-randomized study of CPI-200 in patients
with advanced tumors. CPI-200 is administered via intravenous infusion using an accelerated
titration method followed by a conventional 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-200 in
patients with advanced tumors
Secondary Objectives:
- To evaluate the pharmacokinetics (PK) of CPI-200
- To evaluate clinical response and resolution of symptoms after CPI-200 treatment
- To characterize adverse events of CPI-200 in patients with advanced cancers
Up to 7 dose levels of CPI-200 will be tested using an accelerated titration method followed
by a conventional 3 + 3 dose escalation study design. 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-200 within 21 days:
- All Grade 4 or greater adverse events as determined by CTCAEv5 criteria, excluding
toxicities clearly related to disease progression or inter-current illness
- Any Grade 3 or greater non-hematologic, non-dermatologic toxicity with the exception of
Grade 3 nausea, vomiting or diarrhea if lasting less than 72 hours, alopecia, or Grade 3
fatigue if lasting less than 7 days as determined by CTCAEv5 criteria
- Grade 3 thrombocytopenia in the presence of bleeding
- Grade 3 or greater febrile neutropenia
- Any hematologic or non-hematologic adverse events or abnormal laboratory value(s)
related to CPI-200 that result(s) in permanent study discontinuation of study treatment
Trial Arms
Name | Type | Description | Interventions |
---|
CPI-200 | Experimental | Dose Escalation Group: CPI-200 will be administered via intravenous infusion once every 3 weeks for up to 7 dose levels using an accelerated titration method followed by a conventional 3 + 3 study design
Dose Expansion Group: Maximum tolerated dose or the recommended Phase 2 dose (RP2D) from dose escalation group | |
Eligibility Criteria
Inclusion Criteria:
- Age >18 years
- Males and females
- Have a histologically or cytologically confirmed diagnosis of advanced solid tumor
- Have advanced or metastatic disease refractory to standard curative or palliative
therapy or contraindication to standard therapy
- Have an ECOG performance status of 0-1
- Have a life expectancy of at least 12 weeks (in the opinion of the investigator)
- Have adequate bone marrow reserve, liver and renal function
- Be reasonably recovered from preceding major surgery and no major surgery within 4
weeks prior to the start of Day 1 treatment
- Have a negative pregnancy test for females with child bearing age at screening and
should not be breast feeding
- Be willing to abstain from sexual activity or practice physical barrier contraception
from study entry to 3 months after the last day of treatment
Exclusion Criteria:
- Have peripheral sensory neuropathy of Grade 2 or greater at screening
- Have known hypersensitivity to chemotherapeutic agents
- Have thrombocytopenia with complications including hemorrhage or bleeding > Grade 2
that required medical intervention or any hemolytic condition or coagulation disorders
that would make participation unsafe
- Have unresolved toxicity from previous treatment or previous investigational agents;
excluding alopecia
- Received investigational agents or systemic anticancer agents (other than neurotoxic
compounds) within 5 half lives or 28 days, whichever is shorter, prior to Day 1 of
treatment
- Have signs or symptoms of end organ failure, major chronic illnesses other than
cancer, or any severe concomitant conditions
- Have experienced any of the following within the 6-month period prior to screening:
unstable angina, myocardial infarction or cerebrovascular accident, transient ischemic
attack, cardiac failure with known ejection fraction less than 40%
- Have other severe acute or chronic medical or psychiatric conditions or laboratory
abnormality that would make the patient inappropriate for enrollment in this study
- Is pregnant or breast-feeding
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Maximum Tolerated Dose (MTD) |
Time Frame: | 21 days |
Safety Issue: | |
Description: | • To determine the maximum tolerated dose (MTD), which is defined as the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT) using a 3+3 strategy as assessed by CTCAE |
Secondary Outcome Measures
Measure: | Rate of Clinical Benefit |
Time Frame: | through study completion, an average of 4 months |
Safety Issue: | |
Description: | • To assess clinical benefit by response rate and resolution of symptoms, which will be reported as response rate (%) of participants |
Measure: | Rate of Adverse Effect |
Time Frame: | through study completion, an average of 4 months |
Safety Issue: | |
Description: | • To assess adverse effect as either treatment-related or non-treatment-related as defined by CTCAE, which will be reported as % of participants |
Measure: | Maximum Plasma Concentration (Cmax) |
Time Frame: | 8 Days |
Safety Issue: | |
Description: | • To evaluate maximum plasma concentration (Cmax) of CPI-200 in patients tested |
Measure: | Area Under the Curve (AUC) |
Time Frame: | 8 Days |
Safety Issue: | |
Description: | • To evaluate area under the curve (AUC) of CPI-200 in patients tested |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Coordination Pharmaceuticals, Inc. |
Trial Keywords
- Intravenous infusion
- Phase 1
- CPI-200
Last Updated
July 28, 2021