Know Cancer

or
forgot password

Phase 1/1b, Open-Label, Dose-Escalation and Expansion Study to Evaluate the Safety and Antitumor Activity of MEDI3617 as a Single-Agent or in Combination Therapy in Adult Subjects With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumors, Advanced Recurrent Ovarian Tumors

Thank you

Trial Information

Phase 1/1b, Open-Label, Dose-Escalation and Expansion Study to Evaluate the Safety and Antitumor Activity of MEDI3617 as a Single-Agent or in Combination Therapy in Adult Subjects With Advanced Solid Tumors


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerable dose (MTD) or optimal biological dose (OBD) of MEDI3617

Outcome Description:

Determine the maximum tolerable dose or optimal biological dose, and safety profile of MEDI3617 administered as a single-agent, MEDI3617 co-administered with bevacizumab or weekly paclitaxel monotherapy, or MEDI3617 co-administered with carboplatin plus paclitaxel or carboplatin plus gemcitabine combination chemotherapies in subjects with advanced solid malignances refractory to standard therapy or for which no standard therapy exists

Outcome Time Frame:

21 - 105 days

Safety Issue:

Yes

Principal Investigator

Robert Sikorski, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

MedImmune LLC

Authority:

United States: Food and Drug Administration

Study ID:

CD-ON-MEDI3617-1043

NCT ID:

NCT01248949

Start Date:

October 2010

Completion Date:

December 2014

Related Keywords:

  • Advanced Solid Tumors
  • Advanced Recurrent Ovarian Tumors
  • Advanced solid tumors
  • Advanced recurrent ovarian tumors
  • Ovarian Neoplasms
  • Neoplasms

Name

Location

Research SiteAnaheim, California  
Research SiteBloomington, Indiana  
Research SiteBaltimore, Maryland  
Research SiteBeverly, Massachusetts  
Research SiteBattle Kreek, Michigan  
Research SiteAlbany, New York  
Research SiteAllentown, Pennsylvania  
Research SiteChattanooga, Tennessee