Advanced TumorsPhase 1NCT03781362
Study of CPI-100 in Patients With Advanced Tumors
A Phase 1 study testing CPI-100 and Capecitabine in people with Advanced Tumors, run by Coordination Pharmaceuticals, Inc. at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Tumors
- What is being tested?
- CPI-100 and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Dec 2018to 21 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Be reasonably recovered from preceding major surgery or 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 6 months after the last day of treatment
Who cannot join
- Have peripheral neuropathy of Grade 3 or Grade 4 at screening
- Have peripheral sensory neuropathy of Grade 2 or greater at screening
- Have an interval from previous neurotoxic drugs less than 3 months unless reasonably recovered from all grades of neurotoxicity to grade 1 or lower as judged by the investigator
- Have known hypersensitivity to chemotherapeutic agents
- Have a history of 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
- Is pregnant or breast-feeding
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
South Texas Accelerated Research Therapeutics
Grand Rapids, Michigan, 49546
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
About this study
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
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).
Read the 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)
- Conditions
- Advanced Tumors
- Being tested
- CPI-100, Capecitabine
- Keywords
- Intravenous infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPI-100Drug
CPI-100 will be administered via intravenous infusion on Day 1 of a 14-Day cycle
CapecitabineDrug
Capecitabine will be administered 1000 mg/m2 orally twice a day for 2 weeks followed by a 7-day rest period
| Study group | Role | What they receive |
|---|---|---|
| CPI-100 Monotherapy | Experimental | Dose Escalation Groups:
CPI-100 will be administered via intravenous infusion once every 2 weeks (Q2W) for up to 5 dose levels and once every 3 weeks (Q3W Arm A) for up to 4 dose levels in a 3 + 3 dose escalation study
Dose Expansion Group: Maximum tolerated dose or the recommended Phase 2 dose (RP2D) from dose escalation group Receives: Drug: CPI-100 |
| CPI-100 Combination with Capecitabine | Experimental | CPI-100 will be administered via intravenous infusion once every 3 weeks in combination with oral capecitabine for up to 4 dose levels in a dose escalation study (Q3W Arm B) Receives: Drug: CPI-100; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
- 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 CTCAE5
Measured: 28 Days
Secondary outcomes (4)
Clinical Benefit
- To assess clinical benefit by response rate and resolution of symptoms, which will be reported as response rate (%)
Measured: through study completion, an average of 4 months
Adverse Effect
- To assess adverse effect as either treatment-related or non-treatment-related as defined by CTCAE
Measured: through study completion, an average of 4 months
Maximum Plasma Concentration (Cmax)
- To evaluate maximum plasma concentration (Cmax) of CPI-100 in patients tested
Measured: 8 Days
Area Under the Curve (AUC)
- To evaluate area under the curve (AUC) of CPI-100 in patients tested
Measured: 8 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start21 Dec 2018
- Primary completion21 Jun 2022
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 3 + 3 dose escalation study design
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordination Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781362
- Sponsor's protocol ID
- CPI-CL18-001
- Status last verified
- Jul 2022
- First submitted
- 17 Dec 2018
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be shared due to confidentiality agreements
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03781362
- Acronym / sponsor ID
- CPI-CL18-001
- Conditions
- Advanced Tumors
- Keywords
- Intravenous infusion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Coordination Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 3 + 3 dose escalation study design
| Arm | Type | Receives |
|---|---|---|
| CPI-100 Monotherapy | Experimental | Drug: CPI-100Dose Escalation Groups: CPI-100 will be administered via intravenous infusion once every 2 weeks (Q2W) for up to 5 dose levels and once every 3 weeks (Q3W Arm A) for up to 4 dose levels in a 3 + 3 dose escalation study Dose Expansion Group: Maximum tolerated dose or the recommended Phase 2 dose (RP2D) from dose escalation group |
| CPI-100 Combination with Capecitabine | Experimental | Drug: CPI-100, Drug: CapecitabineCPI-100 will be administered via intravenous infusion once every 3 weeks in combination with oral capecitabine for up to 4 dose levels in a dose escalation study (Q3W Arm B) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Be reasonably recovered from preceding major surgery or 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 6 months after the last day of treatment
Key exclusion criteria (7 listed)
- Have peripheral neuropathy of Grade 3 or Grade 4 at screening
- Have peripheral sensory neuropathy of Grade 2 or greater at screening
- Have an interval from previous neurotoxic drugs less than 3 months unless reasonably recovered from all grades of neurotoxicity to grade 1 or lower as judged by the investigator
- Have known hypersensitivity to chemotherapeutic agents
- Have a history of 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPI-100CPI-100 will be administered via intravenous infusion on Day 1 of a 14-Day cycle | Drug | CPI-100 Combination with Capecitabine, CPI-100 Monotherapy |
| CapecitabineCapecitabine will be administered 1000 mg/m2 orally twice a day for 2 weeks followed by a 7-day rest period | Drug | CPI-100 Combination with Capecitabine |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 28 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 CTCAE5
4 secondary outcomes
Clinical Benefit
Time frame: through study completion, an average of 4 months
Adverse Effect
Time frame: through study completion, an average of 4 months
Maximum Plasma Concentration (Cmax)
Time frame: 8 Days
Area Under the Curve (AUC)
Time frame: 8 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No. The data will not be shared due to confidentiality agreements
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CPI-100 and Capecitabine in people with Advanced Tumors, run by Coordination Pharmaceuticals, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.