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
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ClinicalTrials.gov Identifier: NCT02494596 |
Recruitment Status :
Completed
First Posted : July 10, 2015
Results First Posted : September 30, 2015
Last Update Posted : November 10, 2015
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Solid Tumor |
Interventions |
Drug: Capecitabine Drug: RhuMab 2C4 |
Enrollment | 19 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | Participants were grouped into three cohorts and received either 825 mg, 1000 mg or 1250 mg capecitabine to determine the maximum tolerated dose. |
Arm/Group Title | Capecitabine 825 Plus (+) Pertuzumab 1050 | Capecitabine 1000 + Pertuzumab 1050 | Capecitabine 1250 + Pertuzumab 1050 |
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Participants received a single dose of capecitabine 825 milligrams per square meter (mg/m^2) orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent. | Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent. | Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent. |
Period Title: Overall Study | |||
Started | 5 | 7 | 7 |
Completed | 2 | 2 | 6 |
Not Completed | 3 | 5 | 1 |
Reason Not Completed | |||
Insufficient Therapeutic Response | 3 | 3 | 1 |
Adverse Event | 0 | 1 | 0 |
Refused Treatment | 0 | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Capecitabine + Pertuzumab | |
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Participants received a single dose of capecitabine either 825, 1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent. | |
Overall Number of Baseline Participants | 18 | |
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The Intent-To-Treat (ITT) Population included all participants who received any amount of the study medication. The baseline analysis population represents participants from all three cohorts.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 18 participants | |
60.9 (9.10) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | |
Female |
11 61.1%
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Male |
7 38.9%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: | Medical Communications |
Organization: | Hoffmann-La Roche |
Phone: | 800-821-8590 |
EMail: | genentech@druginfo.com |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT02494596 |
Other Study ID Numbers: |
BO17003 |
First Submitted: | July 8, 2015 |
First Posted: | July 10, 2015 |
Results First Submitted: | July 30, 2015 |
Results First Posted: | September 30, 2015 |
Last Update Posted: | November 10, 2015 |