Clinical trial NCT02494596: A Phase Ib, Open-label, Multicenter Study of the Safety and PK of the Combination of rhuMAb2c4 (Omnitarg), a Recombinant Humanized Antibody to HER2, and Capecitabine (Xeloda) in Patients With Advanced Solid Tumors
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 Capecitabine (Xeloda) in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-07-10
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of rhuMab 2C4(Perjeta) and capecitabine (Xeloda) 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).


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

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 palmar plantar syndrome Grade 2 or worse, or any unresolved residual chemotherapy effects
* Prior HER2-active agents, continuous intravenous (IV) 5-fluorouracil, capecitabine, or other fluoropyrimidine
* Any investigational agent within 28 days of study start
* 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

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of the Combination of Pertuzumab and Capecitabine
timeFrame: Cycle 1 (3 Weeks)
Secondary outcomes:
measure: Percentage of Participants With DLTs
timeFrame: Cycle 1 (3 Weeks)
measure: Plasma Half-Life (t1/2) of Pertuzumab
timeFrame: Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and Predose on Days 8, 15 and 22
measure: Maximum Plasma Concentration (Cmax) of Pertuzumab
timeFrame: Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22
measure: Time to Maximum Plasma Concentration (Tmax) of Pertuzumab
timeFrame: Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22
measure: Area Under the Concentration Curve From Time Zero to Last Measurement (AUC 0-last) of Pertuzumab
timeFrame: Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22
measure: AUC From Time Zero to Infinity (AUC 0-infinity) of Pertuzumab
timeFrame: Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22
measure: Apparent Volume of Distribution of Pertuzumab
timeFrame: Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22
measure: Apparent Total Clearance of Pertuzumab
timeFrame: Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22
measure: Plasma Half-Life of Capecitabine and it's Metabolites When Given Alone and in Combination With Pertuzumab
timeFrame: Day -7: Predose, 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours postdose; Cycle 1 Day 1: Predose, 0 and 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours Postdose
measure: Maximum Plasma Concentration of Capecitabine and it's Metabolites When Given Alone and in Combination With Pertuzumab
timeFrame: Day -7: Predose, 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours postdose; Cycle 1 Day 1: Predose, 0 and 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours Postdose
measure: Time to Maximum Plasma Concentration of Capecitabine and it's Metabolites When Given Alone and in Combination With Pertuzumab
timeFrame: Day -7: Predose, 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours postdose; Cycle 1 Day 1: Predose, 0 and 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours Postdose
Other outcomes:
Locations:
city: Barcelona
country: Spain
city: Manchester
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: