Clinical trialPhase 1Completed
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
- Outcome
- Outcome unknown
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- June 2008
- Expected end
- January 2011
- Enrollment
- 22 participants
- Sites
- 2
- Primary outcomes
- Number of Participants With Dose Limiting Toxicities (DLTs)
- Sponsor
- Industry
- Results posted
- 2012-06-06
- Last update
- 24 December 2013
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Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants With Dose Limiting Toxicities (DLTs) [Baseline up to Cycle 1 / Day 28]. Number, participants. CP-870893 0.1 mg/kg (n=3): 0; CP-870893 0.2 mg/kg (Escalation Cohort) (n=6): 0; CP-870893 0.2 mg/kg (MTD Expansion Cohort) (n=13): 1.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Percentage of Participants With Objective Tumor Response According to Response Evaluation Criteria in Solid Tumors (RECIST) [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]. Number, percentage of participants (95% Confidence Interval). CP-870893 0.1 mg/kg (n=3): 33.3 (0.8 to 90.6); CP-870893 0.2 mg/kg (Escalation Cohort) (n=6): 16.7 (0.4 to 64.1); CP-870893 0.2 mg/kg (MTD Expansion Cohort) (n=13): 7.7 (0.2 to 36.0).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011)]. Median, months (95% Confidence Interval). CP-870893 Combined Dose Cohorts (n=22): 8.4 (5.3 to 11.8).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression Free Survival (PFS) [Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011)]. Median, months (95% Confidence Interval). CP-870893 Combined Dose Cohorts (n=22): 5.3 (3.6 to 7.4).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Time to Progression [Monthly until death or 7.5 months after last participant was enrolled (up to January 2011)].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
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].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [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].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Pre-dose Concentration (CYTO0), Maximum Concentration (CTYOMAX) [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].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Time of Maximum Concentration (TCYTOMAX) [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].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Total and Neutralizing Human Antihuman Antibody (HAHA) Titer [Prior to infusion of CP-870893 on Day 3 of every cycle up to a maximum of 12 cycles].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
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) [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].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
18-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Imaging (MTD Expansion Cohort) [Baseline, Week 2, Week 8, and Single Time Point (STP) PET for all PET scans after Week 8].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Carbohydrate Antigen 19-9 (CA 19-9) [At the end of every even-numbered cycle (cycle=28 days) and 4 to 6 weeks following initial documentation of response].