A Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573 in Subjects With Advanced Solid Tumors

MedImmune

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: MEDI-573

Study type: Interventional

Funder types: Industry

Identifiers

NCT00816361

MI-CP184

Details and patient eligibility

About

Evaluate the safety and tolerability of MEDI-573 in adult subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy exists.

Enrollment: 43 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed advanced solid tumor for which no curative or standard therapies exist.
• Karnofsky Performance Status ≥60.
• Adequate hematological function.
• Adequate organ function.
• Women of non-child-bearing potential (defined as being >1 year post-menopausal) or using effective contraception, e.g., use of oral contraceptives with an additional barrier method (since the investigational product may impair the effectiveness of oral contraceptives), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy, or total abstinence, from the time the informed consent is signed through 30 days after the last dose of MEDI-573. Male subjects with partners of child-bearing potential must be surgically sterile or use contraceptive method as described above from the time of the initiation of MEDI-573 through 30 days after the last dose of MEDI-573.

Exclusion criteria

• No prior treatment within 4 weeks of study drug administration.
• No concurrent therapy for treatment of cancer.
• No uncontrolled diabetes.
• New York Heart Association Grade ≥ 2 congestive heart failure.
• History of myocardial infarction, unstable angina, transient ischemic attack or stroke within the previous 6 months prior to study entry.
• Documented brain metastasis.
• Pregnancy or lactation or plans to become pregnant while on study.
• Clinically significant abnormality on ECG.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 9 patient groups

MEDI-573 0.5 mg/Kg QWk Dose Escalation

Experimental group

Description:

Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.

Treatment:

Drug: MEDI-573

MEDI-573 1.5 mg/Kg QWk Dose Escalation

Experimental group

Description:

Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.

Treatment:

Drug: MEDI-573

MEDI-573 5 mg/Kg QWk Dose Escalation

Experimental group

Description:

Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.

Treatment:

Drug: MEDI-573

MEDI-573 10 mg/Kg QWk Dose Escalation

Experimental group

Description:

Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.

Treatment:

Drug: MEDI-573

MEDI-573 15 mg/Kg QWk Dose Escalation

Experimental group

Description:

Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.

Treatment:

Drug: MEDI-573

MEDI-573 30 mg/Kg Q3Wk Dose Escalation

Experimental group

Description:

Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.

Treatment:

Drug: MEDI-573

MEDI-573 45 mg/Kg Q3Wk Dose Escalation

Experimental group

Description:

Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.

Treatment:

Drug: MEDI-573

MEDI-573 5 mg/Kg QWk Dose Expansion

Experimental group

Description:

Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.

Treatment:

Drug: MEDI-573

MEDI-573 15 mg/Kg QWk Dose Expansion

Experimental group

Description:

Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.

Treatment:

Drug: MEDI-573