Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a dose-finding study; therefore, there is no hypothesis testing
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Schedule A | Other | Schedule A (CP-870,893 administration schedule) |
|
| Schedule B | Other | Schedule B (CP-870,893 administration schedule) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel + Carboplatin + CP-870,893 | Drug | Paclitaxel is administered intravenously on day 1 of a 21-day cycle at a dose of 175 mg/m^2. Carboplatin is administered intravenously on day 1 of a 21-day cycle at AUC 6. CP-870,893 is administered intravenously on DAY 3 of a 21-day cycle in escalating doses (0.1 mg/kg and 0.2 mg/kg) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) | Any of the following during first cycle of treatment and attributable to CP-870893: Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) for ≥7 days; Gr 3 or 4 febrile neutropenia (ANC <1000/mm^3, fever ≥38.5 degrees Celsius; platelets ≤25,000 cells/mm^3); ≥Gr 3 non-hematological adverse event despite optimal supportive care; ≥Gr 3 cytokine release syndrome or acute infusion reaction; failure to recover to Gr <1 toxicity after delaying next cycle by maximum of 2 weeks; Day 3 or 8 ANC <1000 cells/mm^3 or platelets <80000 cells/mm^3, or non-hematologic toxicity ≥Gr 2. | Schedule (Sch) A Cycle 1 / Day 3 or Schedule B Cycle 1 / Day 8 up to Cycle 1 / Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) | Mean of individual observed Cmax values measured as micrograms per milliliter (mcg/mL). | Schedule A Day 3 of each 21 Day Cycle, Schedule B Day 8 of each 21 Day Cycle: Pre-dose, 5 minutes after end of infusion, and 2, 6, and 24 hours (hrs) post-dose up to a maximum of 8 cycles (6 months) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Los Angeles | California | 90025 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40318595 | Derived | Cai S, Wei X, Li Q, Jiang Z, Li L. Smart materials in pharmacological drug development: Neutrophils and its constituents for drug delivery and consequent antitumor effects. Mol Immunol. 2025 Jul;183:18-32. doi: 10.1016/j.molimm.2025.04.010. Epub 2025 May 2. | |
| 23483678 | Derived | Vonderheide RH, Burg JM, Mick R, Trosko JA, Li D, Shaik MN, Tolcher AW, Hamid O. Phase I study of the CD40 agonist antibody CP-870,893 combined with carboplatin and paclitaxel in patients with advanced solid tumors. Oncoimmunology. 2013 Jan 1;2(1):e23033. doi: 10.4161/onci.23033. |
Not provided
Not provided
16 participants were screened, enrolled, and received at least 1 dose of study treatment in Schedule A. 18 participants were screened and enrolled in Schedule B; however, 2 participants discontinued before assignment to study treatment; 16 participants received at least 1 dose of study treatment in Schedule B.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Schedule A - CP-870893 0.1 mg/kg | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle. CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Paclitaxel + Carboplatin + CP-870,893 | Drug | Paclitaxel is administered intravenously on day 1 of a 21-day cycle at a dose of 175 mg/m^2. Carboplatin is administered intravenously on day 1 of a 21-day cycle at AUC 6. CP-870,893 is administered intravenously on DAY 8 of a 21-day cycle in escalating doses (0.1 mg/kg and 0.2 mg/kg) |
|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
Area under the serum concentration time-curve from time zero to the last measured concentration. AUClast was estimated using non-compartmental methods on the sequence of sample measurements. Mean of individual observed AUClast values measured as nanograms multiplied by micrograms per milliliter (ng*mcg/mL). |
| Schedule A Day 3 of each 21 Day Cycle, Schedule B Day 8 of each 21 Day Cycle: Pre-dose, 5 minutes after end of infusion, and 2, 6, and 24 hours post-dose up to a maximum of 8 cycles (6 months) |
| Tumor Response of Partial Response (PR) and Complete Response CR) According to Response Evaluation Criteria in Solid Tumors (RECIST) | Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions. PR was defined as a ≥30% decrease in the sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD. | Schedule A and Schedule B: Baseline and Day 21 of every even numbered cycle up to a maximum of 8 cycles (6 months) |
| Change in Cytokine Concentrations of Interleukin 6 (IL 6): Pre-dose Concentration (CYTO0), Maximum Post-dose Concentration (CYTOMAX) | Concentrations reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction. | Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, end of infusion, 1 , 2, 4, 6, 24, and 48 hours postdose |
| Change in Cytokine Concentrations of Tumor Necrosis Factor Alpha (TNF Alpha): CYTO0, CYTOMAX | Concentrations reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction. | Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, end of infusion, 1 , 2, 4, 6, 24, and 48 hours postdose |
| Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD19 Pre-dose Percentage (PD0), Maximum Post-dose Percentage (PDmax) | Assess activity of B cells (involved in production of antibodies) in presence of CP-870893. Clusters of differentiation (CD) are specific types of proteins on cell surface. CD19 is a B cell antigen receptor and is used to quantitate changes in proportion of B cells in peripheral blood as a consequence of therapy. Higher numbers may indicate a greater presence of CD19 on cell surface with increased potential for antigen response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. | Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose |
| Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD40 PD0, PDmax | Assess activity of B cells in the presence of CP-870893. CD40 is a costimulatory protein and is a target for CP-870893. Measurement of CD40 on white blood cells provides a measure of target modulation by CP-870893. Higher numbers may indicate potential for increased activation of antigen presenting cells. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. | Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose |
| Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD23 PD0, PDmax | Assess activity of B cells in the presence of CP-870893. CD23 is a low-affinity receptor that has a role in transportation in antibody feedback regulation. Agents that engage CD40 have been reported to increase CD23 expression; increased CD23 expression may, therefore, serve as a marker for CD40 binding by CP-870893. Higher numbers may indicate a potential for increased antibody response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. | Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose |
| Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD54 PD0, PDmax | Assess activity of B cells in presence of CP-870893. CD54 is an intercellular adhesion molecule. When activated, leukocytes bind to endothelial cells via CD54 and then transmigrate into tissues. Agents that engage CD40 have been reported to increase CD54 expression; increased CD54 expression may, therefore, serve as a marker for CD40 binding by CP-870893. Higher numbers may indicate potential for increased immune response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. | Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose |
| Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD86 PD0, PDmax | Assess activity of B cells in presence of CP-870893. CD86 is a protein expressed on antigen-presenting cells and provides co-stimulatory signals for T cell (role in cell-modulated immunity) activation. Agents that engage CD40 have been reported to increase CD86 expression; increased CD86 expression may, therefore, serve as a marker for CD40 binding by CP-870893. Higher numbers may indicate potential for increased immune response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. | Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose |
| Change in Bone Marrow Derived Cells (B Cell) Surface Markers: Human Leukocyte Antigen (HLA-DR) PD0, PDmax | Assess activity of B cells in presence of CP-870893. HLA-DR is a component of the Major Histocompatibility Complex in humans and presents antigens for recognition by the immune system. Agents that engage CD40 have been reported to increase HLA-DR expression; increased HLA-DR expression may serve as a marker for CD40 binding by CP-870893. Positive values may indicate greater presence of cells associated with potential for antibody production. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. | Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose |
| Total and Neutralizing Human Antihuman Antibody (HAHA) Titer | HAHA assessed as an indicator of immunogenicity to CP-870893. | Schedule A Day 3 of each 21 Day Cycle, Schedule B Day 8 of each 21 Day Cycle: Pre-dose up to a maximum of 8 cycles (6 months) |
| Santa Monica |
| California |
| 90404 |
| United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort) |
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort). |
| FG002 | Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort). |
| FG003 | Schedule B - CP-870893 0.1 mg/kg | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). |
| FG004 | Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort). |
| FG005 | Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Schedule A - CP-870893 | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort). |
| BG001 | Schedule B - CP-870893 | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) | Any of the following during first cycle of treatment and attributable to CP-870893: Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) for ≥7 days; Gr 3 or 4 febrile neutropenia (ANC <1000/mm^3, fever ≥38.5 degrees Celsius; platelets ≤25,000 cells/mm^3); ≥Gr 3 non-hematological adverse event despite optimal supportive care; ≥Gr 3 cytokine release syndrome or acute infusion reaction; failure to recover to Gr <1 toxicity after delaying next cycle by maximum of 2 weeks; Day 3 or 8 ANC <1000 cells/mm^3 or platelets <80000 cells/mm^3, or non-hematologic toxicity ≥Gr 2. | Safety population: all participants who received at least 1 dose of study treatment. | Posted | Number | participants | Schedule (Sch) A Cycle 1 / Day 3 or Schedule B Cycle 1 / Day 8 up to Cycle 1 / Day 21 |
|
|
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Observed Serum Concentration (Cmax) | Mean of individual observed Cmax values measured as micrograms per milliliter (mcg/mL). | Pharmacokinetic data analysis set: all enrolled participants who started treatment and had baseline and sufficient on-study samples to provide interpretable results. N=number of participants who did not have pre-dose levels of CP-870893. | Posted | Mean | Standard Deviation | mcg/mL | Schedule A Day 3 of each 21 Day Cycle, Schedule B Day 8 of each 21 Day Cycle: Pre-dose, 5 minutes after end of infusion, and 2, 6, and 24 hours (hrs) post-dose up to a maximum of 8 cycles (6 months) |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the serum concentration time-curve from time zero to the last measured concentration. AUClast was estimated using non-compartmental methods on the sequence of sample measurements. Mean of individual observed AUClast values measured as nanograms multiplied by micrograms per milliliter (ng*mcg/mL). | Pharmacokinetic data analysis set; N=number of participants who did not have pre-dose levels of CP-870893. | Posted | Mean | Standard Deviation | hr*mcg/mL | Schedule A Day 3 of each 21 Day Cycle, Schedule B Day 8 of each 21 Day Cycle: Pre-dose, 5 minutes after end of infusion, and 2, 6, and 24 hours post-dose up to a maximum of 8 cycles (6 months) |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Tumor Response of Partial Response (PR) and Complete Response CR) According to Response Evaluation Criteria in Solid Tumors (RECIST) | Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions. PR was defined as a ≥30% decrease in the sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD. | All response-evaluable population: included all participants who had measurable disease, a baseline tumor assessment and who started treatment were considered evaluable for analysis of tumor response. | Posted | Number | participants | Schedule A and Schedule B: Baseline and Day 21 of every even numbered cycle up to a maximum of 8 cycles (6 months) |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Cytokine Concentrations of Interleukin 6 (IL 6): Pre-dose Concentration (CYTO0), Maximum Post-dose Concentration (CYTOMAX) | Concentrations reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction. | Pharmacokinetic data analysis set. | Posted | Mean | Standard Deviation | picograms per milliliter (pg/mL) | Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, end of infusion, 1 , 2, 4, 6, 24, and 48 hours postdose |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Cytokine Concentrations of Tumor Necrosis Factor Alpha (TNF Alpha): CYTO0, CYTOMAX | Concentrations reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction. | Pharmacokinetic data analysis set. CYTO0 values = the lower limit of quantitation (LLOQ). | Posted | Mean | Standard Deviation | pg/mL | Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, end of infusion, 1 , 2, 4, 6, 24, and 48 hours postdose |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD19 Pre-dose Percentage (PD0), Maximum Post-dose Percentage (PDmax) | Assess activity of B cells (involved in production of antibodies) in presence of CP-870893. Clusters of differentiation (CD) are specific types of proteins on cell surface. CD19 is a B cell antigen receptor and is used to quantitate changes in proportion of B cells in peripheral blood as a consequence of therapy. Higher numbers may indicate a greater presence of CD19 on cell surface with increased potential for antigen response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. | Biomarker data analysis set: All enrolled participants who started treatment and who had baseline and sufficient on-study samples to provide interpretable results. N=Number of participants contributing to the mean. | Posted | Mean | Standard Deviation | percentage of cells | Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD40 PD0, PDmax | Assess activity of B cells in the presence of CP-870893. CD40 is a costimulatory protein and is a target for CP-870893. Measurement of CD40 on white blood cells provides a measure of target modulation by CP-870893. Higher numbers may indicate potential for increased activation of antigen presenting cells. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. | Biomarker data analysis set; N=Number of participants contributing to the mean. | Posted | Mean | Standard Deviation | percentage of cells | Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD23 PD0, PDmax | Assess activity of B cells in the presence of CP-870893. CD23 is a low-affinity receptor that has a role in transportation in antibody feedback regulation. Agents that engage CD40 have been reported to increase CD23 expression; increased CD23 expression may, therefore, serve as a marker for CD40 binding by CP-870893. Higher numbers may indicate a potential for increased antibody response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. | Biomarker data analysis set; N=Number of participants contributing to the mean. | Posted | Mean | Standard Deviation | percentage of cells | Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD54 PD0, PDmax | Assess activity of B cells in presence of CP-870893. CD54 is an intercellular adhesion molecule. When activated, leukocytes bind to endothelial cells via CD54 and then transmigrate into tissues. Agents that engage CD40 have been reported to increase CD54 expression; increased CD54 expression may, therefore, serve as a marker for CD40 binding by CP-870893. Higher numbers may indicate potential for increased immune response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. | Biomarker data analysis set; N=Number of participants contributing to the mean. | Posted | Mean | Standard Deviation | percentage of cells | Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD86 PD0, PDmax | Assess activity of B cells in presence of CP-870893. CD86 is a protein expressed on antigen-presenting cells and provides co-stimulatory signals for T cell (role in cell-modulated immunity) activation. Agents that engage CD40 have been reported to increase CD86 expression; increased CD86 expression may, therefore, serve as a marker for CD40 binding by CP-870893. Higher numbers may indicate potential for increased immune response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. | Biomarker data analysis set; N=Number of participants contributing to the mean. | Posted | Mean | Standard Deviation | percentage of cells | Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Bone Marrow Derived Cells (B Cell) Surface Markers: Human Leukocyte Antigen (HLA-DR) PD0, PDmax | Assess activity of B cells in presence of CP-870893. HLA-DR is a component of the Major Histocompatibility Complex in humans and presents antigens for recognition by the immune system. Agents that engage CD40 have been reported to increase HLA-DR expression; increased HLA-DR expression may serve as a marker for CD40 binding by CP-870893. Positive values may indicate greater presence of cells associated with potential for antibody production. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. | Biomarker data analysis set; N=Number of participants contributing to the mean. | Posted | Mean | Standard Deviation | percentage of cells | Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total and Neutralizing Human Antihuman Antibody (HAHA) Titer | HAHA assessed as an indicator of immunogenicity to CP-870893. | Data was not summarized as Human antihuman responses to CP-870893 were all below the limit of quantitation (endpoint titer of 4.32). | Posted | Schedule A Day 3 of each 21 Day Cycle, Schedule B Day 8 of each 21 Day Cycle: Pre-dose up to a maximum of 8 cycles (6 months) |
|
Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Schedule A - CP-870893 0.1 mg/kg | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle. CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort). | 1 | 3 | 3 | 3 | ||
| EG001 | Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort). | 3 | 6 | 6 | 6 | ||
| EG002 | Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort). | 2 | 7 | 7 | 7 | ||
| EG003 | Schedule B - CP-870893 0.1 mg/kg | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). | 0 | 3 | 3 | 3 | ||
| EG004 | Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort). | 3 | 6 | 6 | 6 | ||
| EG005 | Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort). | 2 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Optic nerve infarction | Eye disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Mucosal haemorrhage | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| CD4 lymphocytes decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypogeusia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| C518149 | selicrelumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
Not provided
Not provided
| Male |
|
| OG002 | Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort). |
| OG003 | Schedule B - CP-870893 0.1 mg/kg | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). |
| OG004 | Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort). |
| OG005 | Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort). |
|
|
| OG002 | Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort). |
| OG003 | Schedule B - CP-870893 0.1 mg/kg | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). |
| OG004 | Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort). |
| OG005 | Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort). |
|
|
| OG001 | Schedule B - CP-870893 | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort). |
|
|
| OG002 | Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort). |
| OG003 | Schedule B - CP-870893 0.1 mg/kg | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). |
| OG004 | Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort). |
| OG005 | Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort). |
|
|
| OG002 | Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort). |
| OG003 | Schedule B - CP-870893 0.1 mg/kg | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). |
| OG004 | Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort). |
| OG005 | Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort). |
|
|
| OG002 | Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort). |
| OG003 | Schedule B - CP-870893 0.1 mg/kg | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). |
| OG004 | Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort). |
| OG005 | Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort). |
|
|
| OG002 | Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort). |
| OG003 | Schedule B - CP-870893 0.1 mg/kg | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). |
| OG004 | Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort). |
| OG005 | Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort). |
|
|
| OG002 | Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort). |
| OG003 | Schedule B - CP-870893 0.1 mg/kg | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). |
| OG004 | Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort). |
| OG005 | Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort). |
|
|
| OG002 | Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort). |
| OG003 | Schedule B - CP-870893 0.1 mg/kg | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). |
| OG004 | Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort). |
| OG005 | Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort). |
|
|
| OG002 | Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort). |
| OG003 | Schedule B - CP-870893 0.1 mg/kg | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). |
| OG004 | Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort). |
| OG005 | Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort). |
|
|
| OG002 | Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort). |
| OG003 | Schedule B - CP-870893 0.1 mg/kg | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). |
| OG004 | Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort). |
| OG005 | Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort). |
|
|
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
| OG003 | Schedule B - CP-870893 0.1 mg/kg | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). |
| OG004 | Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort). |
| OG005 | Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort) | Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort). |
|