A Study to Evaluate the Safety and Antitumor Activity in Subjects With Advanced Solid Tumors

NCT ID: NCT01248949

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2015-10-31

Brief 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.

Conditions

Advanced Solid Tumors; Advanced Recurrent Ovarian Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MEDI3617 SINGLE AGENT TOTAL

Participants will receive MEDI3617 via intravenous (IV) infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.

Group Type: EXPERIMENTAL

MEDI3617

Intervention Type: DRUG

Participants will receive MEDI3617 via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons.

MEDI3617 + BEVACIZUMAB Q3W ESCALATION

Participants will receive MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.

Group Type: EXPERIMENTAL

MEDI3617

Intervention Type: DRUG

Participants will receive MEDI3617 via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons.

Bevacizumab

Intervention Type: DRUG

Participants will receive bevacizumab via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons.

MEDI3617 + BEVACIZUMAB Q2W TOTAL

Participants will receive MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.

Group Type: EXPERIMENTAL

MEDI3617

Intervention Type: DRUG

Participants will receive MEDI3617 via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons.

Bevacizumab

Intervention Type: DRUG

Participants will receive bevacizumab via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons.

MEDI3617 + PACLITAXEL TOTAL

Participants will receive MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.

Group Type: EXPERIMENTAL

MEDI3617

Intervention Type: DRUG

Participants will receive MEDI3617 via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons.

Paclitaxel

Intervention Type: DRUG

Participants will receive paclitaxel via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons.

MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL

Participants will receive MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.

Group Type: EXPERIMENTAL

MEDI3617

Intervention Type: DRUG

Participants will receive MEDI3617 via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons.

Paclitaxel

Intervention Type: DRUG

Participants will receive paclitaxel via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons.

Carboplatin

Intervention Type: DRUG

Participants will receive carboplatin via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons.

Interventions

MEDI3617

Participants will receive MEDI3617 via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons.

Intervention Type: DRUG

Bevacizumab

Participants will receive bevacizumab via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons.

Intervention Type: DRUG

Paclitaxel

Participants will receive paclitaxel via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons.

Intervention Type: DRUG

Carboplatin

Participants will receive carboplatin via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MedImmune, LLC

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

Research Site

Los Angeles, California, United States

Research Site

Stanford, California, United States

Research Site

Lafayette, Indiana, United States

Research Site

Baltimore, Maryland, United States

Research Site

Boston, Massachusetts, United States

Research Site

Detroit, Michigan, United States

Research Site

Buffalo, New York, United States

Research Site

New York, New York, United States

Research Site

Philadelphia, Pennsylvania, United States

Research Site

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

CD-ON-MEDI3617-1043

Identifier Type: -

Identifier Source: org_study_id