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

NCT00711191 | Completed Phase 1 Results

• 1 other identifier: A5021005
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pancreatic Neoplasm

Keywords

pancreas cancer; cancer of the pancreas; gemcitabine; chemotherapy; monoclonal antibody; immunotherapy; CD40

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• 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

• Overall Survival (OS)

  Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011)

• Progression Free Survival (PFS)

  Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011)

• Time to Progression

  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

Other Outcomes (1)

• Recommended Phase 2 Dose (RP2D) of CP-870893 in Participants With Advanced Pancreas Cancer

  Baseline up to time of determination of maximum tolerated dose (MTD)

Study Arms (1)

single arm

EXPERIMENTAL

Biological: monoclonal antibody; Drug: chemotherapy

Interventions

monoclonal antibody BIOLOGICAL

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

single arm

chemotherapy DRUG

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

single arm

Eligibility Criteria

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

You may qualify if:

• st-line surgically incurable cancer of the pancreas
• ECOG(Eastern Cooperative Oncology Group) performance status 0-1

You may not qualify if:

• Previous systemic therapy for pancreas cancer
• History of cancer-associated blood clots
• History of autoimmune disease

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• University of Pennsylvania: collaborator

Study Sites (2)

Pfizer Investigational Site

Indianapolis, Indiana, 46202, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 21436454 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Antibodies, Monoclonal; Drug Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

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: June 26, 2008
• First Posted: July 8, 2008
• Study Start: June 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: December 24, 2013
• Results First Posted: June 6, 2012

Record last verified: 2013-11

Locations

US (2)