Redosing With CP-870, 893 in Patients With Clinical Benefit After a Single Infusion From A Phase I, Open-Label, Dose-Escalation Study of CP-870,893 in Patients With Solid Tumors

NCT02157831 | Completed Early Phase 1 DMC

• 1 other identifier: UPCC 10904
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who had clinical benefit following a single infusion of CP-870, 893 on Protocol UPCC 10903 will receive a single repeated infusion of CP-870,893 at the same dose given on UPCC 10903 intravenously.

Conditions

Solid Tumors

Keywords

Subjects with Clinical Benefit After a Single Infusion of CP - 870, 893

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  8 weeks

Study Arms (1)

Subjects from UPCC 10903

EXPERIMENTAL

Biological: CP-870,893

Interventions

CP-870,893 BIOLOGICAL

Subjects from UPCC 10903

Eligibility Criteria

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

You may qualify if:

• Clinical benefit, including stable disease, partial response, or complete response, without a dose-limiting toxicity after a single infusion of CP-870,893; however, patients who experienced transient, not serious, and fully reversible grade 1-3 increases in ALT or AST after one dose of CP-870,893 may, if otherwise eligible, receive a second dose on this protocol.
• Age at least 18 years old;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1;
• Adequate bone marrow function documented within 2 weeks prior to treatment, defined as:
• White blood cell (WBC) count \>3000 cells/μL without growth factor support;
• Absolute neutrophil count (ANC) ≥1500/μL without growth factor support;
• Platelets \>100,000/μL without growth factor support; and
• Hemoglobin ≥10 g/dL.
• Adequate renal and hepatic function documented within 2 weeks prior to treatment, defined as:
• Total bilirubin \<1.5 times the upper limit of normal (ULN);
• Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \<2.5 × ULN;
• Creatinine clearance (CLcr, measured or calculated) \>80 mL/min; and
• Life expectancy of at least 12 weeks;
• Signed written informed consent.

You may not qualify if:

• Concurrent treatment with any anticancer agent;
• History of autoimmune disorder, including pemphigus vulgaris, systemic mastocytosis, systemic lupus erythamatosus, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjörgen's syndrome, vasculitis/arteritis, Behcet's syndrome, inflammatory bowel disease, autoimmune thyroiditis, multiple sclerosis, or other chronic inflammatory disease;
• Treatment with any other cancer therapy from the time of the first dose of CP-870,893, except as noted in Section 4.4; 1 Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events, Version 3.0, DCTD, NCI, NIH, DHHS. 31 Mar 2003 (http://ctep.cancer.gov).
• History of congestive heart failure, stroke, or myocardial infarction;
• Hereditary or acquired coagulopathies (e.g. hemophilia, von Willebrand's disease, cancer-associated DIC);
• Brain metastases.
• Patient having reproductive potential who is not using an effective method of birth control or who is pregnant or breastfeeding or has a positive (urine or serum) pregnancy test at baseline;
• Known sensitivity to immunomodulating agents or monoclonal antibodies;
• Alcohol abuse or illicit drug use within 12 months of enrollment;
• History of serum creatinine ≥2 mg/dL for any duration and for any reason;
• Urine dipstick 1+ or more positive for blood (other than menstruating females) or 2+ or more positive for protein;
• Positive HAHA antibody titer in response to treatment with first dose of CP-870,893 (as determined by Pfizer)
• Clinically significant presence of granular or cellular casts in centrifuged urine sediment;
• Renal carcinoma or renal metastases;
• Partial or complete nephrectomy;

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

selicrelumab

Study Officials

• Robert Vonderheide, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: June 6, 2014
• Study Start: July 1, 2005
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: August 17, 2018

Record last verified: 2018-08

Locations

US (1)