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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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This study aims to seek evidence that activation of certain cells of the immune system will be safe and well tolerated in combination with cytotoxic chemotherapy. Preliminary evidence of clinical anti-tumor activity will be sought.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| monoclonal antibody | Biological | CP-870,893 intravenous administration [IV] on day 3 of 4-week cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | Any of the following during first cycle of treatment and attributable to CP-870893: afebrile Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) ≥7 days or Gr 3 or 4 neutropenia associated with fever (1 oral temperature >38.5 degrees Celsius (C) or 3 oral temperatures >38.0 degrees C in a 24-hour period); Gr 4 thrombocytopenia or Gr 3 thrombocytopenia associated with bleeding; Gr 4 lymphopenia, if coupled with clinical consequence (such as, opportunistic infection) or any other Gr 3 hematological adverse events; ≥Gr 3 non-hematologic toxicities (except alopecia). | Baseline up to Cycle 1 / Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Tumor Response According to Response Evaluation Criteria in Solid Tumors (RECIST) | Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response. |
| Measure | Description | Time Frame |
|---|---|---|
| Recommended Phase 2 Dose (RP2D) of CP-870893 in Participants With Advanced Pancreas Cancer | Additional participants enrolled at MTD of CP-870893 to further characterize suitability for phase 2 testing. RP2D confirmed if ≤ 3 our of 12 participants in expansion cohort experience DLT in cycle 1. | Baseline up to time of determination of maximum tolerated dose (MTD) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Indianapolis | Indiana | 46202 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21436454 | Derived | Beatty GL, Chiorean EG, Fishman MP, Saboury B, Teitelbaum UR, Sun W, Huhn RD, Song W, Li D, Sharp LL, Torigian DA, O'Dwyer PJ, Vonderheide RH. CD40 agonists alter tumor stroma and show efficacy against pancreatic carcinoma in mice and humans. Science. 2011 Mar 25;331(6024):1612-6. doi: 10.1126/science.1198443. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | CP-870893 0.1 mg/kg | Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles. |
| FG001 | CP-870893 0.2 mg/kg (Escalation Cohort) | Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. 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 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles. |
| FG002 | CP-870893 0.2 mg/kg (MTD Expansion Cohort) | Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. 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 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CP-870893 0.1 mg/kg | Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Dose Limiting Toxicities (DLTs) | Any of the following during first cycle of treatment and attributable to CP-870893: afebrile Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) ≥7 days or Gr 3 or 4 neutropenia associated with fever (1 oral temperature >38.5 degrees Celsius (C) or 3 oral temperatures >38.0 degrees C in a 24-hour period); Gr 4 thrombocytopenia or Gr 3 thrombocytopenia associated with bleeding; Gr 4 lymphopenia, if coupled with clinical consequence (such as, opportunistic infection) or any other Gr 3 hematological adverse events; ≥Gr 3 non-hematologic toxicities (except alopecia). | Safety population: all participants who received any study treatment. Cubic millimeters (mm^3). | Posted | Number | participants | Baseline up to Cycle 1 / Day 28 |
|
Treatment emergent adverse events were reported from the time of the first dose of study treatment up to 28 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 | CP-870893 0.1 mg/kg | Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
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| chemotherapy | Drug | gemcitabine 1000 mg/m^2 intravenous administration [IV] q week [wk]x3 of 4-week cycles |
|
| At the end of every even-numbered cycle (cycle=28 days) up to a maximum of 12 cycles and 4 to 6 weeks following initial documentation of response |
| Overall Survival (OS) | OS is time from baseline to death from any cause. Participants last known to be alive were censored at the date of last contact. | Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011) |
| Progression Free Survival (PFS) | PFS is time from baseline to first progression (Prog) or death from any cause. Participants last known to be alive, had not started a new (non-protocol) cancer treatment, were Prog-free, and who had a baseline and ≥1 on-study disease assessment were censored at date of last objective disease assessment that verified lack of Prog. Participants who were off treatment prior to Prog and who had no on-study disease assessment were also censored. Prog: ≥20% increase in sum of longest dimension (LD) of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions. | Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011) |
| Time to Progression | Disease progression defined as ≥20% increase in sum LD of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions. Criteria for progression also included unequivocal progression of existing nontarget lesions. | Monthly until death or 7.5 months after last participant was enrolled (up to January 2011) |
| Maximum Serum Concentration (Cmax) | Cycle 1 / Day 3 pre-dose, 5 minutes after End of Infusion (EOI), and 2, 6, and 24 hours after EOI and pre-dose on Day 3 of every subsequent cycle up to a maximum of 12 cycles |
| 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 analyzed using a noncompartmental approach to estimate individual participant values. | Cycle 1 / Day 3 pre-dose, 5 minutes after EOI, and 2, 6, and 24 hours after EOI and pre-dose on Day 3 of every subsequent cycle up to a maximum of 12 cycles |
| Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Pre-dose Concentration (CYTO0), Maximum Concentration (CTYOMAX) | An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction. Change calculated as mean of pre-dose and maximum post-dose values. | Cycle 1 / Day 1 prior to gemcitabine infusion (0 hour), 5 minutes after EOI and 2, 4, 6, and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-970893 infusion (0 hour), 5 minutes after EOI, and 2, 4, 6, and 24 hours after EOI |
| Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Time of Maximum Concentration (TCYTOMAX) | An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction. Change calculated as mean of pre-dose and maximum post-dose values. | Cycle 1 / Day 1 prior to gemcitabine infusion (0 hour), 5 minutes after EOI and 2, 4, 6, and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-970893 infusion (0 hour), 5 minutes after EOI, and 2, 4, 6, and 24 hours after EOI |
| Total and Neutralizing Human Antihuman Antibody (HAHA) Titer | HAHA assessed as an indicator of immunogenicity to CP-870893. | Prior to infusion of CP-870893 on Day 3 of every cycle up to a maximum of 12 cycles |
| Change (Pre-dose to Post-dose) in Bone Marrow Derived Cells (B Cell) Surface Markers: CD54, CD23, CD40, CD86, and Human Leukocyte Antigen (HLA-DR) | Assess the ability of PF-870893 to activate B-cells and HLA-DR which are involved in the production of antibodies. Change calculated as mean of pre-dose and post-dose values. Positive values indicate greater presence of cells associated with antibody production. | Cycle 1 / Day 1 and Cycle 1 / Day 8 prior to gemcitabine infusion and 6 and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-870893 infusion and 6, 24, and 48 hours after EOI |
| 18-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Imaging (MTD Expansion Cohort) | FDG PET assessment to characterize and monitor tumors before and after study treatment; measured as a standardized uptake value (SUV). A reduction in SUV from baseline for at least 1 tumor may indicate a positive metabolic response to treatment. | Baseline, Week 2, Week 8, and Single Time Point (STP) PET for all PET scans after Week 8 |
| Carbohydrate Antigen 19-9 (CA 19-9) | CA 19-9 or sialylated Lewis (a) antigen (a tumor marker). Values higher than 37 units per milliliter (U/ml) considered abnormal; higher values usually indicate greater presence of disease. | At the end of every even-numbered cycle (cycle=28 days) and 4 to 6 weeks following initial documentation of response |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Withdrawal by Subject |
|
| BG001 | CP-870893 0.2 mg/kg (Escalation Cohort) | Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. 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 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles. |
| BG002 | CP-870893 0.2 mg/kg (MTD Expansion Cohort) | Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. 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 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | CP-870893 0.2 mg/kg (Escalation Cohort) | Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. 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 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles. |
| OG002 | CP-870893 0.2 mg/kg (MTD Expansion Cohort) | Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. 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 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles. |
|
|
| Secondary | Percentage of Participants With Objective Tumor Response According to Response Evaluation Criteria in Solid Tumors (RECIST) | Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response. | Safety population; Confidence Interval (CI) calculated using exact method based on binomial distribution. | Posted | Number | 95% Confidence Interval | percentage of participants | At the end of every even-numbered cycle (cycle=28 days) up to a maximum of 12 cycles and 4 to 6 weeks following initial documentation of response |
|
|
|
| Secondary | Overall Survival (OS) | OS is time from baseline to death from any cause. Participants last known to be alive were censored at the date of last contact. | Safety population; Kaplan-Meier estimate of time to event 95 percent confidence interval (95% CI) for 50% quartile based on Brookmeyer and Crowley Method. | Posted | Median | 95% Confidence Interval | months | Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011) |
|
|
|
| Secondary | Progression Free Survival (PFS) | PFS is time from baseline to first progression (Prog) or death from any cause. Participants last known to be alive, had not started a new (non-protocol) cancer treatment, were Prog-free, and who had a baseline and ≥1 on-study disease assessment were censored at date of last objective disease assessment that verified lack of Prog. Participants who were off treatment prior to Prog and who had no on-study disease assessment were also censored. Prog: ≥20% increase in sum of longest dimension (LD) of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions. | Safety population; Kaplan-Meier estimate of time to event 95% CI for 50% quartile based on Brookmeyer and Crowley Method. Criteria for progression also included unequivocal progression of existing nontarget lesions. | Posted | Median | 95% Confidence Interval | months | Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011) |
|
|
|
| Secondary | Time to Progression | Disease progression defined as ≥20% increase in sum LD of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions. Criteria for progression also included unequivocal progression of existing nontarget lesions. | No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893. | Posted | Monthly until death or 7.5 months after last participant was enrolled (up to January 2011) |
|
|
| Secondary | Maximum Serum Concentration (Cmax) | No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893. | Posted | Cycle 1 / Day 3 pre-dose, 5 minutes after End of Infusion (EOI), and 2, 6, and 24 hours after EOI and pre-dose on Day 3 of every subsequent cycle up to a maximum of 12 cycles |
|
|
| 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 analyzed using a noncompartmental approach to estimate individual participant values. | No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893. | Posted | Cycle 1 / Day 3 pre-dose, 5 minutes after EOI, and 2, 6, and 24 hours after EOI and pre-dose on Day 3 of every subsequent cycle up to a maximum of 12 cycles |
|
|
| Secondary | Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Pre-dose Concentration (CYTO0), Maximum Concentration (CTYOMAX) | An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction. Change calculated as mean of pre-dose and maximum post-dose values. | No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893. | Posted | Cycle 1 / Day 1 prior to gemcitabine infusion (0 hour), 5 minutes after EOI and 2, 4, 6, and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-970893 infusion (0 hour), 5 minutes after EOI, and 2, 4, 6, and 24 hours after EOI |
|
|
| Secondary | Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Time of Maximum Concentration (TCYTOMAX) | An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction. Change calculated as mean of pre-dose and maximum post-dose values. | No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893. | Posted | Cycle 1 / Day 1 prior to gemcitabine infusion (0 hour), 5 minutes after EOI and 2, 4, 6, and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-970893 infusion (0 hour), 5 minutes after EOI, and 2, 4, 6, and 24 hours after EOI |
|
|
| Secondary | Total and Neutralizing Human Antihuman Antibody (HAHA) Titer | HAHA assessed as an indicator of immunogenicity to CP-870893. | No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893. | Posted | Prior to infusion of CP-870893 on Day 3 of every cycle up to a maximum of 12 cycles |
|
|
| Secondary | Change (Pre-dose to Post-dose) in Bone Marrow Derived Cells (B Cell) Surface Markers: CD54, CD23, CD40, CD86, and Human Leukocyte Antigen (HLA-DR) | Assess the ability of PF-870893 to activate B-cells and HLA-DR which are involved in the production of antibodies. Change calculated as mean of pre-dose and post-dose values. Positive values indicate greater presence of cells associated with antibody production. | No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893. | Posted | Cycle 1 / Day 1 and Cycle 1 / Day 8 prior to gemcitabine infusion and 6 and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-870893 infusion and 6, 24, and 48 hours after EOI |
|
|
| Secondary | 18-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Imaging (MTD Expansion Cohort) | FDG PET assessment to characterize and monitor tumors before and after study treatment; measured as a standardized uptake value (SUV). A reduction in SUV from baseline for at least 1 tumor may indicate a positive metabolic response to treatment. | No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893. | Posted | Baseline, Week 2, Week 8, and Single Time Point (STP) PET for all PET scans after Week 8 |
|
|
| Secondary | Carbohydrate Antigen 19-9 (CA 19-9) | CA 19-9 or sialylated Lewis (a) antigen (a tumor marker). Values higher than 37 units per milliliter (U/ml) considered abnormal; higher values usually indicate greater presence of disease. | No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893. | Posted | At the end of every even-numbered cycle (cycle=28 days) and 4 to 6 weeks following initial documentation of response |
|
|
| Other Pre-specified | Recommended Phase 2 Dose (RP2D) of CP-870893 in Participants With Advanced Pancreas Cancer | Additional participants enrolled at MTD of CP-870893 to further characterize suitability for phase 2 testing. RP2D confirmed if ≤ 3 our of 12 participants in expansion cohort experience DLT in cycle 1. | Safety population | Posted | Number | mg/kg | Baseline up to time of determination of maximum tolerated dose (MTD) |
|
|
|
| 2 |
| 3 |
| 3 |
| 3 |
| EG001 | CP-870893 0.2 mg/kg (Escalation Cohort) | Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. 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 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles. | 2 | 6 | 6 | 6 |
| EG002 | CP-870893 0.2 mg/kg (MTD Expansion Cohort) | Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. 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 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles. | 5 | 13 | 12 | 13 |
| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Faeces pale | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Catheter site haemorrhage | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Early satiety | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nodule | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Suprapubic pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Full blood count decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Neutrophil count | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Muscle contractions involuntary | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Parosmia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Glomerulonephritis | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Endodontic procedure | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 13.1 | 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.
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013812 | Therapeutics |