Study of CPI-200 in Patients With Advanced Tumors
Study Details
Study Description
Brief Summary
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
Primary Objectives:
• To determine the safety, tolerability and maximum tolerated dose (MTD) of CPI-200 in patients with advanced tumors
Secondary Objectives:
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To evaluate the pharmacokinetics (PK) of CPI-200
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To evaluate clinical response and resolution of symptoms after CPI-200 treatment
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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:
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All Grade 4 or greater adverse events as determined by CTCAEv5 criteria, excluding toxicities clearly related to disease progression or inter-current illness
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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
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Grade 3 thrombocytopenia in the presence of bleeding
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Grade 3 or greater febrile neutropenia
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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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CPI-200 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 |
Drug: CPI-200
CPI-200 will be administered via intravenous infusion on Day 1 of a 21-Day cycle
|
Outcome Measures
Primary Outcome Measures
- Maximum Tolerated Dose (MTD) [21 days]
• 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
- Rate of Clinical Benefit [through study completion, an average of 4 months]
• To assess clinical benefit by response rate and resolution of symptoms, which will be reported as response rate (%) of participants
- Rate of Adverse Effect [through study completion, an average of 4 months]
• To assess adverse effect as either treatment-related or non-treatment-related as defined by CTCAE, which will be reported as % of participants
- Maximum Plasma Concentration (Cmax) [8 Days]
• To evaluate maximum plasma concentration (Cmax) of CPI-200 in patients tested
- Area Under the Curve (AUC) [8 Days]
• To evaluate area under the curve (AUC) of CPI-200 in patients tested
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age >18 years
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Males and females
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Have a histologically or cytologically confirmed diagnosis of advanced solid tumor
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Have advanced or metastatic disease refractory to standard curative or palliative therapy or contraindication to standard therapy
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Have an ECOG performance status of 0-1
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Have a life expectancy of at least 12 weeks (in the opinion of the investigator)
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Have adequate bone marrow reserve, liver and renal function
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Be reasonably recovered from preceding major surgery and no major surgery within 4 weeks prior to the start of Day 1 treatment
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Have a negative pregnancy test for females with child bearing age at screening and should not be breast feeding
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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:
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Have peripheral sensory neuropathy of Grade 2 or greater at screening
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Have known hypersensitivity to chemotherapeutic agents
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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
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Have unresolved toxicity from previous treatment or previous investigational agents; excluding alopecia
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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
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Have signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions
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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%
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Have other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that would make the patient inappropriate for enrollment in this study
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Is pregnant or breast-feeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | South Texas Accelerated Research Therapeutics (START Midwest) | Grand Rapids | Michigan | United States | 49546 |
Sponsors and Collaborators
- Coordination Pharmaceuticals, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CPI-200CL01