DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Solid Tumor

Intervention: Docetaxel (Drug); RhuMab 2C4 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche


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).

Clinical Details

Official title: A Phase Ib, Open-Label, Multicenter Study of the Safety and Pharmacokinetics of the Combination of RhuMab 2C4 (Omnitarg), a Recombinant Humanized Antibody to HER2, and Docetaxel (Taxotere) in Patients With Advanced Solid Tumors

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximum tolerated dose (MTD) of the combination of rhuMab 2C4 and docetaxel

Secondary outcome:

Incidence of adverse events according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 3.0

Incidence of DLTs

Area under the concentration-time curve extrapolated to infinity (AUC0-inf) of docetaxel and rhuMab 2C4

Elimination half-life (t1/2) of docetaxel and rhuMab 2C4

Clearance (Cl) of docetaxel and rhuMab 2C4

Maximum plasma concentration (Cmax) of rhuMab 2C4

Volume of distribution (Vss) of rhuMab 2C4

Mean residence time (MRT) of rhuMab 2C4

Left ventricular ejection fraction (LVEF)

Percentage of participants by best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST)

Objective Response Rate (ORR)


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Locations and Contacts

Rotterdam 3075 EA, Netherlands

Sutton SM2 5PT, United Kingdom

Additional Information

Starting date: February 2004
Last updated: July 2, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017