CancerPhase 1NCT01204996
A Study of the Safety and Efficacy of CNTO 888 in Combination With SoC (Standard of Care) Chemotherapy in Patients With Solid Tumors
A Phase 1 study testing CNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injection, CNTO888 + gemcitabine and CNTO888 + Paclitaxel and carboplatin in people with Cancer, run by Centocor, Inc. at 5 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and dose regimen of CNTO 888 when administered to patients with solid tumors in combination with 4 standard of care chemotherapy regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- CNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injection, CNTO888 + gemcitabine and CNTO888 + Paclitaxel and carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 5 sitesin 2 countries
- Study dates
- May 2010to Nov 2011
- 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
- Documentation of an advanced solid tumor
- No more than 2 previous anticancer therapies
- good performance status
- adequate bone marrow, liver, and renal function / adequate blood test values
- willing to use birth control measures
Who cannot join
- No residual toxicities resulting from previous therapy
- no known allergies, hypersensitivity, or intolerance to antibodies or chemotherapies
- clinically significant bleeding or requiring concurrent therapeutic dose of anticoagulation
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States2 sites
Study site
Detroit, Michigan
Study site
Tacoma, Washington
About this study
Official title: An Open-label, Multicenter, Phase 1b Study of CNTO 888 (an Anti-CCL 2 Monoclonal Antibody) in Combination With Chemotherapies for the Treatment of Subjects With Solid Tumors
The purpose of this study is to evaluate the safety and dose regimen of CNTO 888 when administered to patients with solid tumors in combination with 4 standard of care chemotherapy regimens.
Read the detailed description
CNTO 888 is an antibody that works by blocking a protein called CC-chemokine ligand 2 (CCL2). In research studies CCL2, has been shown to increase the growth of new blood vessels which help the tumor to survive. It is hoped that blocking CCL2 may help to control tumor growth.
Patients will receive one of four treatments. A dose of 15 mg/kg CNTO 888 will be administered once every 3 weeks in combination with either docetaxel, gemcitabine, or paclitaxel-carboplatin in Treatment Arms 1, 2, and 3, respectively; and 10 mg/kg CNTO 888 will be administered once every 2 weeks with DOXIL® / Caelyx® (doxorubicin HCl liposome injection) for intravenous infusion once every 4 weeks in Treatment Arm 4. The maximum time that patients will be in the study is one year.
Safety assessments will be conducted throughout the course of the study. Safety assessments include the monitoring of side effects,clinical laboratory tests (hematology, biochemistry, and urinalysis), vital signs, and physical examinations. CNTO 888 will be administered IV at 2 different doses (15 mg/kg or 10 mg/kg) dependant on the chemotherapy combination. Combination therapy will be continued until disease progression, unacceptable toxicity, the patient refuses further combination therapy, withdraws consent, or is treated for 1 year
- Conditions
- Cancer
- Being tested
- CNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injection, CNTO888 + gemcitabine, CNTO888 + Paclitaxel and carboplatin, CNTO888 + docetaxel
- Keywords
- monoclonal antibody, solid tumor, chemotherapy, standard of care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injectionDrug
10 mg/kg CNTO 888 every 2 weeks plus DOXIL®/Caelyx® (doxorubicin HCl liposome injection) 50 mg/m2 every 4 weeks
CNTO888 + gemcitabineDrug
15 mg/kg CNTO 888 every 3 weeks plus gemcitabine 1000 mg/m2 administered on Days 1 and 8 of the 3-week cycle
CNTO888 + Paclitaxel and carboplatinDrug
15 mg/kg CNTO 888 every 3 weeks plus paclitaxel 175 mg/m2 and carboplatin dosed to AUC 6 every 3 weeks
CNTO888 + docetaxelDrug
15 mg/kg CNTO 888 every 3 weeks plus docetaxel 75 mg/m2 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CNTO888 + docetaxel 15 mg/kg CNTO 888 every 3 weeks plus docetaxel 75 mg/m2 every 3 weeks Receives: Drug: CNTO888 + docetaxel |
| 2 | Experimental | CNTO888 + gemcitabine 15 mg/kg CNTO 888 every 3 weeks plus gemcitabine 1000 mg/m2 administered on Days 1 and 8 of the 3-week cycle Receives: Drug: CNTO888 + gemcitabine |
| 3 | Experimental | CNTO888 + Paclitaxel and carboplatin 15 mg/kg CNTO 888 every 3 weeks plus paclitaxel 175 mg/m2 and carboplatin dosed to AUC 6 every 3 weeks Receives: Drug: CNTO888 + Paclitaxel and carboplatin |
| 4 | Experimental | CNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injection 10 mg/kg CNTO 888 every 2 weeks plus DOXIL®/Caelyx® (doxorubicin HCl liposome injection) 50 mg/m2 every 4 weeks Receives: Drug: CNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to evaluate the safety of CNTO 888 when administered to patients with solid tumors in combination with 4 standard of care chemotherapy regimens.
Measured: During treatment and up to 30 days after last study treatment
Secondary outcomes (2)
Pharmacokinetics(rate of movement in the body and then the clearance)
Measured: during study as specified in the protocol (interim analysis) and at End of Study (1 year)
Pharmacodynamics (action of drug on body systems)
Measured: during study as specified in the protocol (interim analysis) and at End of Study (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startMay 2010
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centocor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Centocor, Inc. Clinical Trial, Study director, Centocor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204996
- Sponsor's protocol ID
- CR016462
- Other IDs
- 2009-015541-23, CNTO888STM1002, 2009
- Status last verified
- May 2012
- First submitted
- 16 Sep 2010
- Last updated
- 30 May 2012
- Results posted
- No
Publications
Brana I, Calles A, LoRusso PM, Yee LK, Puchalski TA, Seetharam S, Zhong B, de Boer CJ, Tabernero J, Calvo E. Carlumab, an anti-C-C chemokine ligand 2 monoclonal antibody, in combination with four chemotherapy regimens for the treatment of patients with solid tumors: an open-label, multicenter phase 1b study. Target Oncol. 2015 Mar;10(1):111-23. doi: 10.1007/s11523-014-0320-2. Epub 2014 Jun 15.
PubMed 24928772
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase 1b Study of CNTO 888 (an Anti-CCL 2 Monoclonal Antibody) in Combination With Chemotherapies for the Treatment of Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT01204996
- Acronym / sponsor ID
- CR016462
- Conditions
- Cancer
- Keywords
- monoclonal antibody, solid tumor, chemotherapy, standard of care
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Centocor, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Study completion
- Nov 2011 (actual)
- First posted
- 20 Sep 2010 (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.
The purpose of this study is to evaluate the safety and dose regimen of CNTO 888 when administered to patients with solid tumors in combination with 4 standard of care chemotherapy regimens.
Detailed description
CNTO 888 is an antibody that works by blocking a protein called CC-chemokine ligand 2 (CCL2). In research studies CCL2, has been shown to increase the growth of new blood vessels which help the tumor to survive. It is hoped that blocking CCL2 may help to control tumor growth.
Patients will receive one of four treatments. A dose of 15 mg/kg CNTO 888 will be administered once every 3 weeks in combination with either docetaxel, gemcitabine, or paclitaxel-carboplatin in Treatment Arms 1, 2, and 3, respectively; and 10 mg/kg CNTO 888 will be administered once every 2 weeks with DOXIL® / Caelyx® (doxorubicin HCl liposome injection) for intravenous infusion once every 4 weeks in Treatment Arm 4. The maximum time that patients will be in the study is one year.
Safety assessments will be conducted throughout the course of the study. Safety assessments include the monitoring of side effects,clinical laboratory tests (hematology, biochemistry, and urinalysis), vital signs, and physical examinations. CNTO 888 will be administered IV at 2 different doses (15 mg/kg or 10 mg/kg) dependant on the chemotherapy combination. Combination therapy will be continued until disease progression, unacceptable toxicity, the patient refuses further combination therapy, withdraws consent, or is treated for 1 year
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CNTO888 + docetaxelCNTO888 + docetaxel 15 mg/kg CNTO 888 every 3 weeks plus docetaxel 75 mg/m2 every 3 weeks |
| 2 | Experimental | Drug: CNTO888 + gemcitabineCNTO888 + gemcitabine 15 mg/kg CNTO 888 every 3 weeks plus gemcitabine 1000 mg/m2 administered on Days 1 and 8 of the 3-week cycle |
| 3 | Experimental | Drug: CNTO888 + Paclitaxel and carboplatinCNTO888 + Paclitaxel and carboplatin 15 mg/kg CNTO 888 every 3 weeks plus paclitaxel 175 mg/m2 and carboplatin dosed to AUC 6 every 3 weeks |
| 4 | Experimental | Drug: CNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injectionCNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injection 10 mg/kg CNTO 888 every 2 weeks plus DOXIL®/Caelyx® (doxorubicin HCl liposome injection) 50 mg/m2 every 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documentation of an advanced solid tumor
- No more than 2 previous anticancer therapies
- good performance status
- adequate bone marrow, liver, and renal function / adequate blood test values
- willing to use birth control measures
Key exclusion criteria (3 listed)
- No residual toxicities resulting from previous therapy
- no known allergies, hypersensitivity, or intolerance to antibodies or chemotherapies
- clinically significant bleeding or requiring concurrent therapeutic dose of anticoagulation
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 |
|---|---|---|
| CNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injection10 mg/kg CNTO 888 every 2 weeks plus DOXIL®/Caelyx® (doxorubicin HCl liposome injection) 50 mg/m2 every 4 weeks | Drug | 4 |
| CNTO888 + gemcitabine15 mg/kg CNTO 888 every 3 weeks plus gemcitabine 1000 mg/m2 administered on Days 1 and 8 of the 3-week cycle | Drug | 2 |
| CNTO888 + Paclitaxel and carboplatin15 mg/kg CNTO 888 every 3 weeks plus paclitaxel 175 mg/m2 and carboplatin dosed to AUC 6 every 3 weeks | Drug | 3 |
| CNTO888 + docetaxel15 mg/kg CNTO 888 every 3 weeks plus docetaxel 75 mg/m2 every 3 weeks | Drug | 1 |
Primary outcome
The primary objective of the study is to evaluate the safety of CNTO 888 when administered to patients with solid tumors in combination with 4 standard of care chemotherapy regimens.
Time frame: During treatment and up to 30 days after last study treatment
2 secondary outcomes
Pharmacokinetics(rate of movement in the body and then the clearance)
Time frame: during study as specified in the protocol (interim analysis) and at End of Study (1 year)
Pharmacodynamics (action of drug on body systems)
Time frame: during study as specified in the protocol (interim analysis) and at End of Study (1 year)
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 30 May 2012.
- Derived from this study: PubMed 24928772Brana I, Calles A, LoRusso PM, Yee LK, Puchalski TA, Seetharam S, Zhong B, de Boer CJ, Tabernero J, Calvo E. Carlumab, an anti-C-C chemokine ligand 2 monoclonal antibody, in combination with four chemotherapy regimens for the treatment of patients with solid tumors: an open-label, multicenter phase 1b study. Target Oncol. 2015 Mar;10(1):111-23. doi: 10.1007/s11523-014-0320-2. Epub 2014 Jun 15.
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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.
Centocor, Inc. Clinical Trial study director
Centocor, Inc.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injection, CNTO888 + gemcitabine and CNTO888 + Paclitaxel and carboplatin in people with Cancer, run by Centocor, Inc. at 5 sites in 2 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 5 inclusion and 3 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 30 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, 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?
The primary objective of the study is to evaluate the safety of CNTO 888 when administered to patients with solid tumors in combination with 4 standard of care chemotherapy regimens. (time frame: During treatment and up to 30 days after last study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01204996, which also lists 1 linked publication.
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 30 May 2012.