Phase 1
N=32
Dose Finding Study Of CP-870,893, An Immune System Stimulating Antibody, In Combination With Paclitaxel And Carboplatin For Patients With Metastatic Solid Tumors
Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00607048 ↗Enrolled (actual)
32
Serious AEs
34.4%
Results posted
Oct 2012
Primary outcome: Primary: Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) — 0; 1; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Paclitaxel + Carboplatin + CP-870,893 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) |
0; 1; 0; 0; 1; 0 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) |
0.97; 1.51; 1.36; 0.61; 1.97; 1.06 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
3.37; 10.4; 7.5; 1.35; 13.0; 5.71 | — |
| SECONDARY Tumor Response of Partial Response (PR) and Complete Response CR) According to Response Evaluation Criteria in Solid Tumors (RECIST) |
0; 0; 2; 3 | — |
| SECONDARY Change in Cytokine Concentrations of Interleukin 6 (IL 6): Pre-dose Concentration (CYTO0), Maximum Post-dose Concentration (CYTOMAX) |
10.57; 12.10; 14.52; 3.547; 41.34; 8.040 | — |
| SECONDARY Change in Cytokine Concentrations of Tumor Necrosis Factor Alpha (TNF Alpha): CYTO0, CYTOMAX |
15.60; 15.60; 15.60; 15.60; 15.60; 15.60 | — |
| SECONDARY Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD19 Pre-dose Percentage (PD0), Maximum Post-dose Percentage (PDmax) |
5.81; 9.12; 11.3257; 13.5233; 9.42; 6.5514 | — |
| SECONDARY Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD40 PD0, PDmax |
99.265; 99.8267; 99.0043; 99.9833; 99.6533; 88.07 | — |
| SECONDARY Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD23 PD0, PDmax |
71.155; 86.2267; 80.4843; 90.2333; 85.26; 83.0943 | — |
| SECONDARY Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD54 PD0, PDmax |
95.735; 94.7667; 97.9486; 99.6367; 96.4867; 94.5571 | — |
| SECONDARY Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD86 PD0, PDmax |
3.91; 5.8167; 18.7629; 5.5367; 9.23; 16.7186 | — |
| SECONDARY Change in Bone Marrow Derived Cells (B Cell) Surface Markers: Human Leukocyte Antigen (HLA-DR) PD0, PDmax |
98.24; 98.325; 99.0986; 99.7833; 97.4; 98.5643 | — |
| SECONDARY Total and Neutralizing Human Antihuman Antibody (HAHA) Titer |
— | — |
Summary
This is a dose-finding study; therefore, there is no hypothesis testing
Eligibility Criteria
Inclusion Criteria
- Patients with metastatic solid tumors, for whom carboplatin and paclitaxel are appropriate;
- Patients >18 years of age;
- Good performance status;
- Adequate bone marrow and organ function
Exclusion Criteria
- Previous treatment with any other compound that targets CD40
- Current or planned concurrent treatment with any anticancer agent;
- Patients who have received bone marrow transplant;
- History of autoimmune disorder
- History (within the previous year) of heart failure or heart attack
- Cancer-associated coagulation disorders
Data sourced from ClinicalTrials.gov (NCT00607048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.