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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015541-23 | EudraCT Number | ||
| CNTO888STM1002 | Other Identifier | Centocor |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | CNTO888 + docetaxel 15 mg/kg CNTO 888 every 3 weeks plus docetaxel 75 mg/m2 every 3 weeks |
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| 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 |
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| 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 |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injection | Drug | 10 mg/kg CNTO 888 every 2 weeks plus DOXIL®/Caelyx® (doxorubicin HCl liposome injection) 50 mg/m2 every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During treatment and up to 30 days after last study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics(rate of movement in the body and then the clearance) | during study as specified in the protocol (interim analysis) and at End of Study (1 year) | |
| Pharmacodynamics (action of drug on body systems) | during study as specified in the protocol (interim analysis) and at End of Study (1 year) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Centocor, Inc. Clinical Trial | Centocor, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Detroit | Michigan | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24928772 | Derived | 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. |
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| CNTO888 + gemcitabine | Drug | 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 carboplatin | Drug | 15 mg/kg CNTO 888 every 3 weeks plus paclitaxel 175 mg/m2 and carboplatin dosed to AUC 6 every 3 weeks |
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| CNTO888 + docetaxel | Drug | 15 mg/kg CNTO 888 every 3 weeks plus docetaxel 75 mg/m2 every 3 weeks |
|
| Tacoma |
| Washington |
| United States |
| Barcelona | Spain |
| Madrid | Spain |
| PAU de Sanchinarro | Spain |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C581643 | carlumab |
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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