A Phase I, Multicenter Dose Escalation Study in Patients With Hairy Cell Leukemia

Summary

A dose-escalation study to identify the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD), defined as the highest dose that can safely be given to a participant and establish the safest dose based on the highest tolerated dose for clinical testing.

Conditions

• Hairy Cell Leukemia

Interventions

DRUG

Moxetumomab Pasudotox (CAT 8015)

Participants received intravenous infusion of 5 microgram per kilogram (mcg/kg) moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

DRUG

Moxetumomab Pasudotox (CAT 8015)

Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

DRUG

Moxetumomab Pasudotox (CAT 8015)

Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

DRUG

Moxetumomab Pasudotox (CAT 8015)

Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

DRUG

CAT 8015 (Moxetumomab Pasudotox)

Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

DRUG

Moxetumomab Pasudotox (CAT 8015)

Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

Sponsors & Collaborators

• Cambridge Antibody Technology

  collaborator OTHER

• MedImmune LLC

  lead INDUSTRY

Principal Investigators

• MedImmune LLC · MedImmune LLC

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-05-10

Primary Completion

2015-05-06

Completion

2015-05-06

Countries

• United States
• Poland

Study Locations