Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
7 September 2015 |
Main ID: |
NCT02488811 |
Date of registration:
|
30/06/2015 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Phase I, Dose-escalating, Clinical and Pharmacokinetic Study of Humanized ?himeric Anti-CD47 Antibody in Patients With Verified Diagnosis of Breast Cancer ( ASSIST-II )
ASSIST-II |
Scientific title:
|
Phase I, Dose-escalating, Clinical and Pharmacokinetic Study of Humanized ?himeric Anti-CD47 Antibody in Patients With Verified Diagnosis of Breast Cancer |
Date of first enrolment:
|
January 2013 |
Target sample size:
|
99 |
Recruitment status: |
Active, not recruiting |
URL:
|
https://clinicaltrials.gov/show/NCT02488811 |
Study type:
|
Interventional |
Study design:
|
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
Phase:
|
Phase 1
|
|
Countries of recruitment
|
Czech Republic
|
Germany
|
Poland
|
Romania
|
Russian Federation
|
Ukraine
| | |
Contacts
|
Name:
|
Andrej Petrov, MD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Cancer Center |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Women, 18 years or older, with breast cancer.
- Histological or cytological evidence of malignancy.
- Molecular genetic study on the analysis of typical gene mutations.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Subjects must have adequate organ function as assessed by specific laboratory values:
- Absolute neutrophil count (ANC) = 1.5 x 109/L without growth factor support for 7
days (14 days if pegfilgastrim).
- Hemoglobin (Hgb) = 10 g/dL.
- Platelets (plt) = 75 x 109/L without transfusion for 7 days.
- Potassium within normal limits or correctable with supplements.
- Aspartate aminotransferase / serum glutamic oxaloacetic transaminase (AST/SGOT) and
Alanine aminotransferase/ serum glutamate pyruvic transaminase (ALT/SGPT) = 2.5 x
Upper Limit of Normal (ULN) or = 5.0 x ULN if liver tumor is present.
- Lactate dehydrogenase (LDH) = 2 x ULN or = 4 x ULN if liver tumor is present
- Uric acid = 7.5 mg/dL (446 umol/L)
- Serum bilirubin = 1.5 x ULN.
- Estimated serum creatinine clearance of = 60 mL/min
- International normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time
(PTT) < 1.5 x ULN.
- Females must agree to contraceptive methods and avoid conceiving throughout the
study, and for up to 8 weeks following the last dose of antibody CD47.
- Female subjects of childbearing potential must have negative pregnancy test within 5
days prior to first dose of study drug.
- Payment of charitable contributions may be required.
Exclusion Criteria:
- Patients with neoperabelnoy tumor / metastases in a state of collapse (necrosis)
- Women who are breast-feeding, pregnant, or intend to become pregnant.
- Hematologic malignancies other than lymphoma
- Any of the following within 6 months prior to administration of study drug:
- Myocardial infarction (MI), severe /unstable angina pectoris, coronary/peripheral
artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident,
transient ischemic attack or seizure disorder.
- Serious and/or symptomatic active infection within 14 days prior to first dose of
study drug.
- Subjects who have asymptomatic or mild infection and taking a short course of
antibiotics (ie, UTI, bronchitis) may be allowed after discussion with the medical
monitor.
- Baseline QTc interval as follows per Bazett's formula: Females > 470 msec; Males >
450 msec.
= Persistent, unresolved CTCAE v3.0 Grade 2 or higher drug-related toxicity (except
alopecia, erectile dysfunction, hot flashes, and decreased libido) associated with
previous treatment.
- Inadequate recovery from any prior surgical procedure or major surgical procedure
performed within 4 weeks prior to administration of first dose or major surgery
within 3 weeks prior to first dose of study drug.
- Any other medical or psychiatric condition that, in the opinion of the investigator,
might interfere with the subject's participation in the trial or interfere with the
interpretation of trial results.
- Known Human Immunodeficiency Virus (HIV) infection or a known HIV-related malignancy.
- Known active hepatitis B or C.
- Radiotherapy within 3 weeks prior to first study drug administration. Inability to
comply with the protocol requirements or participation in any other clinical study.
- Any medications listed in the table on "Prohibited Medications".
- Active alcohol abuse.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Female
|
Health Condition(s) or Problem(s) studied
|
Breast Cancer
|
Intervention(s)
|
Drug: Antibody CD47
|
Primary Outcome(s)
|
Dose-Limiting Toxicity (DLT)
[Time Frame: Up to 6 months]
|
Secondary Outcome(s)
|
Antitumor efficacy
[Time Frame: up to 12 month]
|
Secondary ID(s)
|
XTCCA-233-99
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|