Study of Samalizumab in Patients With Advanced Cancer

Advanced Solid Tumors Clinical Trial

Official title:

A Multicenter, Dose-Escalation, Phase 1 Study of Samalizumab (ALXN6000) to Evaluate the Pharmacokinetics, Safety, and Tolerability in Patients With Advanced Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02987504
• Other study ID #: ALXN6000-ONC-102
• Status: Terminated
• Phase: Phase 1
• Start date: November 17, 2016
• Est. completion date: September 27, 2017

Study information

• Verified date: July 2018
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, open-label, dose-escalation, Phase 1 study of intravenous (IV) samalizumab to determine its maximum tolerated dose (MTD), overall safety/tolerability, pharmacokinetic and pharmacodynamic parameters, and efficacy in participants with advanced cancer. The study was terminated for administrative reasons and not due to any safety concerns.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 27, 2017
• Est. primary completion date: September 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female participant was = 18 years of age at Screening.

2. Eastern Cooperative Oncology Group performance status of 0 to 2.

3. Participant had advanced/metastatic cancer with disease progression after treatment with all available therapies known to confer clinical benefit.

4. Participant had a life expectancy of greater than 12 weeks.

Exclusion Criteria:

1. Participant had a symptomatic brain metastasis.

2. Participant had active gastrointestinal bleeding as evidenced by either hematemesis or melena.

3. Participant had acute gastrointestinal ulcers.

4. Participant had a history of any cancer other than the present condition (except nonmelanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for a minimum of 3 years.

5. Participant with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration.

6. Participant had an active infection requiring therapy.

7. Participant's serum was positive for the presence of hepatitis B surface antigen, antibodies to hepatitis C virus, or antibodies to human immunodeficiency virus 1/2.

8. Participant had significant cardiovascular impairment (history of New York Heart Association Functional Classification system Class III or IV) or a history of myocardial infarction or unstable angina within the past 6 months prior to study drug treatment.

9. The participant's most recent test values within 14 days before the date of entry met the following standards:

• Bone marrow function: neutrophil count =1500/millimeter (mm)^3, hemoglobin =9.0 grams/deciliter, platelet count =100,000/mm^3.

• Liver function: total bilirubin =1.5 x the upper limit of normal (ULN) based on the standard value of each institution, aspartate aminotransferase and alanine aminotransferase =2.5 x ULN based on the reference laboratory.

• Renal function: serum creatinine =1.5 x ULN based on the reference laboratory.

10. Participant had ongoing immune-stimulated adverse events from other immunotherapies (for example, pneumonitis, thyroiditis, or hepatitis) or a history of pneumonitis.

11. Participant had received chemotherapy, targeted therapy, and/or immunotherapy within the 28 days prior to first dose of study drug, or within a Washout Period for the chemotherapy, targeted therapy, and/or immunotherapy of 5 half-lives, whichever occurred first.

12. Participant had toxicities from previous immunotherapy that had not resolved to Grade 1.

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• Samalizumab
Samalizumab is a humanized, anti CD200 monoclonal antibody provided as a sterile 5 mg/milliliters (mL) solution for IV administration.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals	Quintiles, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number Of Participants Experiencing DLT Graded According To CTCAE Version 4.03, Observed In The Cycle 1 In Order To Meet The Objective Of Assessment Of The MTD	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Safety monitoring began at the informed consent obtained and continued up to 28 days after the last dose of samalizumab or until new anti-tumor therapy, whichever was earlier.
Primary	Maximum Plasma Concentration After Administration Of Samalizumab		21 days in Cycle 1
Primary	Area Under The Plasma Drug Concentration-time Curve After Administration Of Samalizumab		21 days in Cycle 1
Secondary	Objective Response Rate Using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1		Up to 2 Years
Secondary	Disease Control Rate Using RECIST 1.1		Up to 2 Years
Secondary	Duration Of Response		Up to 2 Years
Secondary	Progression Free Survival		Up to 2 Years
Secondary	Overall Survival		Up to last participant completing at least 6 months