A Multiple-Dose Study of RhuMab 2C4 and Docetaxel in the Treatment of Advanced Solid Tumors

NCT ID: NCT02490475

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2006-04-30

Brief Summary

This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of rhuMab 2C4 (Perjeta) and docetaxel (Taxotere) in participants with advanced solid tumors that have progressed during or after standard therapy, or for which no standard therapy is available. Participants will be enrolled and evaluated for dose-limiting toxicities (DLTs) in escalating-dose cohorts in order to determine the maximum tolerated dose (MTD).

Conditions

Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RhuMab 2C4 + Docetaxel 100 mg/m^2 (Level 3)

Docetaxel will be administered via intravenous (IV) infusion on Day 1 of each 3-week cycle at a dose of 100 mg/m\^2 per day, and rhuMab 2C4 will be given on Day 1 of each 3-week cycle as a fixed-dose 420-mg IV infusion. For Cycle 1 only, rhuMab 2C4 administration will be delayed to Day 2 with an initial 840-mg loading dose. The incidence of DLTs will be used to guide intrapatient dose modification, as well as subsequent enrollment.

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Participants will receive docetaxel on Day 1 of each 3-week cycle as 60, 75, or 100 mg/m\^2 via IV infusion. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.

RhuMab 2C4

Intervention Type: DRUG

Participants will receive rhuMab 2C4 on Day 1 of each 3-week cycle as 420 mg via IV infusion. For Cycle 1 ony, rhuMab will be administered on Day 2, at least 24 hours after docetaxel and following an initial 840-mg loading dose. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.

RhuMab 2C4 + Docetaxel 60 mg/m^2 (Level 1)

Docetaxel will be administered via IV infusion on Day 1 of each 3-week cycle at a dose of 60 mg/m\^2 per day, and rhuMab 2C4 will be given on Day 1 of each 3-week cycle as a fixed-dose 420-mg IV infusion. For Cycle 1 only, rhuMab 2C4 administration will be delayed to Day 2 with an initial 840-mg loading dose. The incidence of DLTs will be used to guide intrapatient dose modification, as well as subsequent enrollment.

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Participants will receive docetaxel on Day 1 of each 3-week cycle as 60, 75, or 100 mg/m\^2 via IV infusion. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.

RhuMab 2C4

Intervention Type: DRUG

Participants will receive rhuMab 2C4 on Day 1 of each 3-week cycle as 420 mg via IV infusion. For Cycle 1 ony, rhuMab will be administered on Day 2, at least 24 hours after docetaxel and following an initial 840-mg loading dose. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.

RhuMab 2C4 + Docetaxel 75 mg/m^2 (Level 2)

Docetaxel will be administered via IV infusion on Day 1 of each 3-week cycle at a dose of 75 mg/m\^2 per day, and rhuMab 2C4 will be given on Day 1 of each 3-week cycle as a fixed-dose 420-mg IV infusion. For Cycle 1 only, rhuMab 2C4 administration will be delayed to Day 2 with an initial 840-mg loading dose. The incidence of DLTs will be used to guide intrapatient dose modification, as well as subsequent enrollment.

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Participants will receive docetaxel on Day 1 of each 3-week cycle as 60, 75, or 100 mg/m\^2 via IV infusion. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.

RhuMab 2C4

Intervention Type: DRUG

Participants will receive rhuMab 2C4 on Day 1 of each 3-week cycle as 420 mg via IV infusion. For Cycle 1 ony, rhuMab will be administered on Day 2, at least 24 hours after docetaxel and following an initial 840-mg loading dose. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.

Interventions

Docetaxel

Participants will receive docetaxel on Day 1 of each 3-week cycle as 60, 75, or 100 mg/m\^2 via IV infusion. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.

Intervention Type: DRUG

RhuMab 2C4

Participants will receive rhuMab 2C4 on Day 1 of each 3-week cycle as 420 mg via IV infusion. For Cycle 1 ony, rhuMab will be administered on Day 2, at least 24 hours after docetaxel and following an initial 840-mg loading dose. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.

Intervention Type: DRUG

Other Intervention Names

Taxotere; Omnitarg

Eligibility Criteria

Inclusion Criteria

• Adults at least 18 years of age
• Easter Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy at least 12 weeks
• Locally advanced or metastatic solid tumor with at least 1 measurable lesion, which has progressed during/after standard therapy
• Human epidermal growth factor receptor 2 (HER2)-negative among participants with breast cancer
• Negative pregnancy test or use of an adequate contraceptive method among women of childbearing potential
• Adequate hematologic, hepatic, and renal function
• Signed informed consent, histologically or cytologicall confirmed advanced solid tumor, adequate cardiac function as documented by LVEF >50% by ECHO or MUGA

Exclusion Criteria

• Clinical evidence of central nervous system (CNS) metastases
• Prior chemotherapy, radiotherapy, or immunotherapy within 4 weeks, or hormone therapy within 2 weeks of study Day 1
• History of neuropathy Grade 2 or worse, or any unresolved residual chemotherapy effects
• Prior HER2-active agents or docetaxel
• Any investigational agent within 28 days of study drug
• Prior cumulative doxorubicin dose greater than (>) 360 mg/m^2 or equivalent
• Significant cardiovascular disease
• Active/uncontrolled concurrent illness or infection-
• Major surgery or trauma within 4 weeks of study Day 1

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

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Rotterdam, , Netherlands

Sutton, , United Kingdom

Countries

Netherlands; United Kingdom

Other Identifiers

BO17021

Identifier Type: -

Identifier Source: org_study_id