Hematologic MalignanciesPhase 1/2NCT00405743
A Phase I/II Study of CP-4055 in Patients With Refractory/Relapsed Hematologic Malignancies
A Phase 1/2 study testing CP-4055 in people with Hematologic Malignancies and AML, run by Clavis Pharma at 16 sites in 6 countries.
Trial summary
Patients with refractory or relapsed hematologic malignancies will receive CP-4055 intravenously(IV) on Day 1-5 every three weeks until complete response or disease worsening/progressing Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancies, AML
- What is being tested?
- CP-4055
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 16 sitesin 6 countries
- Study dates
- May 2006to May 2010
- Phase
- Phase 1/2
- 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
- ARM A and B: Phase I CP-4055 single agent 1. Patients must have relapsed/refractory leukemias for which no standard therapies are anticipated to result in a durable response or have failed potentially curative therapy, or have refused or are considered unsuitable for standard therapy
- ARM C: CP-4055 in combination with idarubicin
- Patients with relapsed/refractory AML for which no standard therapies are anticipated to result in a durable response or who have failed potentially curative therapy, or who refuse or are considered unsuitable for standard therapy
- ARM A, B, C: CP-4055 as single agent and/or in combination with idarubicin
- Patients must be 18 years of age or older
- Patients must have ECOG performance status (PS) of 0 - 2. See Appendix 3
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- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study. Nursing patients are excluded.
- Male and female patients must use acceptable contraceptive methods for the duration of time on study, and males also for 3 months after the last CP-4055 dose
- Patients must be capable of understanding and complying with parameters as outlined in the protocol, and able and willing to sign a written informed consent form
- In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents.
- Patients must have the following clinical laboratory values:
- Serum creatinine less or equal to 1.5 x the institutional upper limit of normal (ULN)
- Total bilirubin less or equal to 1.5 x the ULN unless considered due to Gilbert's syndrome
- Alanine aminotransferase (ALT) (SGPT), or aspartate aminotransferase (AST) (SGOT) less or equal to 2.5 x the ULN unless considered due to organ leukemic involvement
- Phase II
- 1. Patients with a confirmed diagnosis of AML who have received cytotoxic chemotherapy
- 2 - 7. Identical to inclusion criteria nos. 2 - 7 for phase I
Who cannot join
- Phase I AND II
- A history of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to CP-4055, i.e., ara-C and/or egg
- Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C
- Pregnant and nursing patients are excluded
- Uncontrolled intercurrent illness
- Active heart disease
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- Patients receiving any other standard or investigational cytotoxic treatment for their hematologic malignancy other than a maximum of 5 g of hydroxyurea to a maximum of 5 days in cycle 1 of therapy
- Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
- Patients with hypersensitivity to idarubicin or any other component of the product, and/or other anthracyclines or anthracenediones
Trial locations and contacts
16 sites in 6 countries.
16 sites in 6 countries
United States5 sites
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Duke University Medical Center (DUMC)
Durham, North Carolina, 27710
MD Anderson Cancer Center
Houston, Texas, 77030
Institute for Drug Development (IDD), Cancer Therapy and Research Center, 7979 Wurzbach Rd.
San Antonio, Texas, 78229
Mew York Medical College, Division of Oncology
Valhalla, New York, 10595
France4 sites
Hematology Service, Hôpital Beaujon and Hôpital Avicenne
Bobigny, Paris, 93009
Centre Hospitalier Universitaire, CHU de Lyon, Service d'Hematologie Clinique
Lyon, 69437
Institut Paoli-Calmettes
Marseille, 13273
Centre Hospitalier Universitaire CHU de Toulouse, Hopital Purpan
Toulouse, 40031-31059
Germany3 sites
University Hospital Benjamin Franklin Med.Clinic III
Berlin, 12200
Department of Internal Medicine Klinikum der Johann Wolfgang Goethe-Universität Medizinische Klinik II
Frankfurt am Main, 60590
Westfälische Wilhelms-Universität Münster Medizinische Klinik und Polikinik Innere Medizin A
Münster, 48129
Italy2 sites
Institute of Hematology & Medical Oncology L and A Serágnoli University of Bologna
Bologna, 40138
Universitá degli Studi di Roma Ematologia- Policlinico Tor Vergata
Rome, 00133
Norway1 site
Department of Hematology, Ullevål University Hospital, University of Oslo
Oslo, 0407
About this study
Patients with refractory or relapsed hematologic malignancies will receive CP-4055 intravenously(IV) on Day 1-5 every three weeks until complete response or disease worsening/progressing
Read the detailed description
This is a multicentre clinical study conducted in the USA and in Europe. It is an open label, dose escalation study designed to characterize the safety, tolerability, pharmacokinetics (PK), and efficacy of CP-4055 as a single agent when administered as a 2 hours intravenous (IV) or a continuous IV (CIV) infusion administered daily for 5 days in a 21-day cycle, either alone or with idarubicin IV, in patients with refractory/relapsed hematologic malignancies who have either failed potentially curative therapy or are considered unsuitable for standard therapy.
In a second phase of the study the efficacy of single agent CP-4055 in patients with AML may be assessed.
It is intended that patients receive a minimum of two cycles of therapy in the absence of unacceptable toxicity or significant disease progression.
- Conditions
- Hematologic Malignancies, AML
- Being tested
- CP-4055
- Keywords
- CP-4055, ELACYT™, Cancer, Refractory, Relapsed, Hematologic Malignancies, Leukemia, ALL, AML, AMM, CLL, CML, CMML, MDS
- Medical subject headings
- Hematologic Neoplasms, Neoplasms, Recurrence, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-4055Drug
CP-4055 Continuous IV infusion
CP-4055Drug
CP4055 2 and 4 hour IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | CP4055, 2 and 4 hour IV infusion Receives: Drug: CP-4055 |
| Arm B | Experimental | CP-4055, Continuous IV infusion Receives: Drug: CP-4055 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Determine the MTD and PK properties of CP-4055 single agent.
Measured: Q4 2007
Phase II: Determine the efficacy of CP-4055 single agent in AML
Measured: Q4 2007
Secondary outcomes (3)
Phase I: Evaluate the safety profile of CP-4055 single agent.
Measured: Q4 2007
Determine the MTD and PK of CP-4055 in combination with idarubicin.
Measured: Q2 2008
Phase II: Extended evaluation of the safety profile of CP-4055 single agent in AML
Measured: Q2 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2006 (estimated)
- Study startMay 2006
- Primary completionMay 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clavis Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francis J Giles, MD, Principal investigator, Institute for Drug Development (IDD), Cancer Therapy and Research Center, San Antonio, Texas, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405743
- Sponsor's protocol ID
- CP4055-106
- Status last verified
- Sep 2013
- First submitted
- 29 Nov 2006
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of CP-4055 in Patients With Refractory/Relapsed Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT00405743
- Acronym / sponsor ID
- CP4055-106
- Conditions
- Hematologic Malignancies, AML
- Keywords
- CP-4055, ELACYT™, Cancer, Refractory, Relapsed, Hematologic Malignancies, Leukemia, ALL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Clavis PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 30 Nov 2006 (estimated)
- 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.
Patients with refractory or relapsed hematologic malignancies will receive CP-4055 intravenously(IV) on Day 1-5 every three weeks until complete response or disease worsening/progressing
Detailed description
This is a multicentre clinical study conducted in the USA and in Europe. It is an open label, dose escalation study designed to characterize the safety, tolerability, pharmacokinetics (PK), and efficacy of CP-4055 as a single agent when administered as a 2 hours intravenous (IV) or a continuous IV (CIV) infusion administered daily for 5 days in a 21-day cycle, either alone or with idarubicin IV, in patients with refractory/relapsed hematologic malignancies who have either failed potentially curative therapy or are considered unsuitable for standard therapy.
In a second phase of the study the efficacy of single agent CP-4055 in patients with AML may be assessed.
It is intended that patients receive a minimum of two cycles of therapy in the absence of unacceptable toxicity or significant disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: CP-4055CP4055, 2 and 4 hour IV infusion |
| Arm B | Experimental | Drug: CP-4055CP-4055, Continuous IV infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- ARM A and B: Phase I CP-4055 single agent 1. Patients must have relapsed/refractory leukemias for which no standard therapies are anticipated to result in a durable response or have failed potentially curative therapy, or have refused or are considered unsuitable for standard therapy
- ARM C: CP-4055 in combination with idarubicin
- Patients with relapsed/refractory AML for which no standard therapies are anticipated to result in a durable response or who have failed potentially curative therapy, or who refuse or are considered unsuitable for standard therapy
- ARM A, B, C: CP-4055 as single agent and/or in combination with idarubicin
- Patients must be 18 years of age or older
Key exclusion criteria (9 listed)
- Phase I AND II
- A history of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to CP-4055, i.e., ara-C and/or egg
- Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C
- Pregnant and nursing patients are excluded
- Uncontrolled intercurrent illness
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 |
|---|---|---|
| CP-4055CP-4055 Continuous IV infusion | Drug | Arm B |
| CP-4055CP4055 2 and 4 hour IV infusion | Drug | Arm A |
Primary outcome
Phase I: Determine the MTD and PK properties of CP-4055 single agent.
Time frame: Q4 2007
Phase II: Determine the efficacy of CP-4055 single agent in AML
Time frame: Q4 2007
3 secondary outcomes
Phase I: Evaluate the safety profile of CP-4055 single agent.
Time frame: Q4 2007
Determine the MTD and PK of CP-4055 in combination with idarubicin.
Time frame: Q2 2008
Phase II: Extended evaluation of the safety profile of CP-4055 single agent in AML
Time frame: Q2 2008
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 18 Sep 2013.
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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.
Francis J Giles, MD principal investigator
Institute for Drug Development (IDD), Cancer Therapy and Research Center, San Antonio, Texas, USA
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CP-4055 in people with Hematologic Malignancies and AML, run by Clavis Pharma at 16 sites in 6 countries.
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 17 inclusion and 9 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 18 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, France, Germany, Italy, Norway and 1 more country. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Phase I: Determine the MTD and PK properties of CP-4055 single agent. (time frame: Q4 2007). The study lists 2 primary outcomes in all. 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 18 Sep 2013.