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

MedImmune

Status and phase: Completed; Phase 1

Conditions: Advanced Recurrent Ovarian Tumors; Advanced Solid Tumors

Treatments: Drug: Bevacizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: MEDI3617

Study type: Interventional

Funder types: Industry

Identifiers

NCT01248949

CD-ON-MEDI3617-1043

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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162 participants in 5 patient groups

MEDI3617 SINGLE AGENT TOTAL

Experimental group

Description:

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.

Treatment:

Drug: MEDI3617

MEDI3617 + BEVACIZUMAB Q3W ESCALATION

Experimental group

Description:

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.

Treatment:

Drug: Bevacizumab

Drug: MEDI3617

MEDI3617 + BEVACIZUMAB Q2W TOTAL

Experimental group

Description:

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.

Treatment:

Drug: Bevacizumab

Drug: MEDI3617

MEDI3617 + PACLITAXEL TOTAL

Experimental group

Description:

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.

Treatment:

Drug: MEDI3617

Drug: Paclitaxel

MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL

Experimental group

Description:

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.

Treatment:

Drug: Carboplatin

Drug: MEDI3617

Drug: Paclitaxel