Dose Finding Study Of CP-870,893, An Immune System Stimulating Antibody, In Combination With Paclitaxel And Carboplatin For Patients With Metastatic Solid Tumors

NCT00607048 | Completed Phase 1 Results

• 1 other identifier: A5021004
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 4

Brief Summary

This is a dose-finding study; therefore, there is no hypothesis testing

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• Maximum Observed Serum Concentration (Cmax)

  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)

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

  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)

  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)

  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

  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

Study Arms (2)

Schedule A

OTHER

Schedule A (CP-870,893 administration schedule)

Drug: Paclitaxel + Carboplatin + CP-870,893

Schedule B

OTHER

Schedule B (CP-870,893 administration schedule)

Drug: Paclitaxel + Carboplatin + CP-870,893

Interventions

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)

Schedule A

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (4)

Pfizer Investigational Site

Los Angeles, California, 90025, United States

Location

Pfizer Investigational Site

Santa Monica, California, 90404, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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.

  PMID: 23483678 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Paclitaxel; Carboplatin; selicrelumab

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: February 5, 2008
• Study Start: November 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: March 27, 2017
• Results First Posted: October 31, 2012

Record last verified: 2017-02

Locations

US (4)