Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

All Drugs and Chemicals

Antineoplastic Agents

Gastrointestinal Agents

Antibodies

Antibodies, Monoclonal

Gemcitabine

Immunomodulating Agents

Immunoglobulins

Pancrelipase

Pancreatin

Adjuvants, Immunologic

Immunologic Factors

CP-870,893 intravenous administration \[IV\] on day 3 of 4-week cycles

monoclonal antibody

gemcitabine 1000 mg/m\^2 intravenous administration \[IV\] q week \[wk\]x3 of 4-week cycles

chemotherapy

Pfizer CT.gov Call Center

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.

A Study On An Immunostimulant Antibody In Combination With Chemotherapy For Advanced Cancer Of The Pancreas

A Phase 1 Dose Escalation Open Label Study Of CP-870,893 In Combination With Gemcitabine In Patients With Chemotherapy-Naïve Surgically Incurable Pancreatic 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.

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).

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.

OS is time from baseline to death from any cause. Participants last known to be alive were censored at the date of last contact.

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.

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.

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.

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.

HAHA assessed as an indicator of immunogenicity to CP-870893.

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.

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.

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.

University of Pennsylvania

Hoffmann-La Roche

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.

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.

CP-870893 0.1 mg/kg

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.

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 0.2 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.

CP-870893 0.2 mg/kg (MTD Expansion Cohort)

Total

Age, Continuous

Sex: Female, Male

Pfizer ClinicalTrials.gov Call Center

Safety population: all participants who received any study treatment. Cubic millimeters (mm\^3).

Number of Participants With Dose Limiting Toxicities (DLTs)

Safety population; Confidence Interval (CI) calculated using exact method based on binomial distribution.

Percentage of Participants With Objective Tumor Response According to Response Evaluation Criteria in Solid Tumors (RECIST)

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. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort) for up to a maximum of 12 cycles. Subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and 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. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and 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.

CP-870893 Combined Dose Cohorts

Safety population; Kaplan-Meier estimate of time to event 95 percent confidence interval (95% CI) for 50% quartile based on Brookmeyer and Crowley Method.

Overall Survival (OS)

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.

Progression Free Survival (PFS)

No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.

Time to Progression

Maximum Serum Concentration (Cmax)

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Pre-dose Concentration (CYTO0), Maximum Concentration (CTYOMAX)

Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Time of Maximum Concentration (TCYTOMAX)

Total and Neutralizing Human Antihuman Antibody (HAHA) Titer

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)

18-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Imaging (MTD Expansion Cohort)

Carbohydrate Antigen 19-9 (CA 19-9)

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.

Subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and 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.

Additional participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and 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.

Spots Global Cancer Trial Database for A Study On An Immunostimulant Antibody In Combination With Chemotherapy For Advanced Cancer Of The Pancreas

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial