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
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).
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 3.0Incidence 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)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Rotterdam 3075 EA, Netherlands
Sutton SM2 5PT, United Kingdom
Additional Information
Starting date: February 2004
Last updated: July 2, 2015
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