A Study to Evaluate the Safety and Antitumor Activity in Subjects With Advanced Solid Tumors
Condition: Advanced Solid Tumors; Advanced Recurrent Ovarian Tumors
MeSH terms: Neoplasms; Ovarian Neoplasms
Intervention: MEDI3617; Bevacizumab; Paclitaxel; Carboplatin
Intervention description: Participants will receive MEDI3617 via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons.; Participants will receive bevacizumab via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons.; Participants will receive paclitaxel via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons.; Participants will receive carboplatin via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons.
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Advanced solid tumors; Advanced recurrent ovarian tumors; MEDI3617; Ang2; Ovarian cancer; Malignant glioma

Summary:

      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.
    

Eligibility criteria:

        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