Trial Search Results
A Study to Evaluate the Safety and Antitumor Activity in Subjects With Advanced Solid Tumors
The purpose of this study is to determine the maximum tolerated dose or optimal biological dose, and the safety profile of MEDI3617 when given as a single-agent or in combination with other chemotherapeutic agents in subjects with advanced solid malignancies resistant to standard therapy.
MEDI3617 is an antibody (a type of protein) that was designed in the laboratory. Preclinical (animal-based) studies suggest that MEDI3617 can slow down the process of new blood vessels being formed in tumors, thereby “starving” the tumor of nutrients and oxygen needed to keep growing.
Stanford is currently not accepting patients for this trial.
Lead Sponsor:
MedImmune LLC
Stanford Investigator(s):
Intervention(s):
- Drug: MEDI3617
- Drug: Bevacizumab
- Drug: Paclitaxel
- Drug: Carboplatin
Phase:
Phase 1
Eligibility
Inclusion Criteria:
- Patients with confirmed diagnosis of advanced solid tumors (dose-escalation phase) or
another solid tumor type based on antitumoral activity (dose-expansion phase) that are
not responsive to standard therapy or for which no standard therapy exists
- Patients must be 18 years of age or older
- Karnofsky Performance Status ≥ 70
- Toxicities from previous cancer therapies must have recovered to CTCAE Grade = or < 2
- Adequate organ and marrow function
- Using adequate contraceptive measures, be surgically sterile or post-menopausal
Exclusion Criteria:
- Concurrently enrolled in another clinical study, except for non-interventiona
observational studies, or if in a follow up period from a previous study
- Receipt of any investigational anticancer therapy within 30 days prior to the first
dose of MEDI3617, or in the case of monoclonal antibodies (eg, bevacizumab), 42 days
prior to the first dose of MEDI3617
- Current or previous treatment with angiopoietin inhibitors, or inhibitors of Tie1 or
Tie2 including, but not limited to, AMG386, CVX-060, XL880, and XL820
- Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy
for cancer treatment
- Use of immunosuppressive medication or systemic steroids within 7 days prior to first
dose of MEDI3617
- Any condition that, in the opinion of the investigator, would interfere with
evaluation of the investigational product or interpretation of subject safety or study
results
- Known bleeding diathesis
- Pulmonary hemorrhage or gross hemoptysis within 6 months prior to enrollment
- Therapeutic or palliative radiation therapy within 2 weeks prior to enrollment
Ages Eligible for Study
18 Years - 99 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061
Not Recruiting