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A Phase 2 Study of Pertuzumab and Erlotinib for Refractory Pancreatic Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT01108458
Recruitment Status : Terminated (Extreme toxicity of Pertuzumab and Erlotinib combination)
First Posted : April 22, 2010
Results First Posted : March 3, 2017
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
George Albert Fisher, Stanford University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Pertuzumab
Drug: Erlotinib
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pertuzumab Plus Erlotinib Hydrochloride
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Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks

Erlotinib hydrochloride 150 mg/day by mouth

Pertuzumab: iv, 840 mg, 420 mg

Erlotinib: PO, 150 mg

Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Pertuzumab Plus Erlotinib Hydrochloride
Hide Arm/Group Description

Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks

Erlotinib hydrochloride 150 mg/day by mouth

Pertuzumab: iv, 840 mg, 420 mg

Erlotinib: PO, 150 mg

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Overall Response Rate by RECIST Criteria
Hide Description [Not Specified]
Time Frame CT imaging every 9 weeks while on protocol
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pertuzumab Plus Erlotinib Hydrochloride
Hide Arm/Group Description:

Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks

Erlotinib hydrochloride 150 mg/day by mouth

Pertuzumab: iv, 840 mg, 420 mg

Erlotinib: PO, 150 mg

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description

Disease status evaluated by computed tomography (CT) scan and progression-free survival assessed per RECIST criteria.

Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported.

Time Frame 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pertuzumab Plus Erlotinib Hydrochloride
Hide Arm/Group Description:

Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks

Erlotinib hydrochloride 150 mg/day by mouth

Pertuzumab: iv, 840 mg, 420 mg

Erlotinib: PO, 150 mg

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pertuzumab Plus Erlotinib Hydrochloride
Hide Arm/Group Description:

Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks

Erlotinib hydrochloride 150 mg/day by mouth

Pertuzumab: iv, 840 mg, 420 mg

Erlotinib: PO, 150 mg

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Quality of Life (QoL)
Hide Description Quality of life as assessed by EORTC QLQ-C30 questionnaire
Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pertuzumab Plus Erlotinib Hydrochloride
Hide Arm/Group Description:

Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks

Erlotinib hydrochloride 150 mg/day by mouth

Pertuzumab: iv, 840 mg, 420 mg

Erlotinib: PO, 150 mg

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title No. of Events of Drug-related Toxicity
Hide Description Number of incidences of serious and non-serious drug-related adverse events
Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pertuzumab Plus Erlotinib Hydrochloride
Hide Arm/Group Description:

Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks

Erlotinib hydrochloride 150 mg/day by mouth

Pertuzumab: iv, 840 mg, 420 mg

Erlotinib: PO, 150 mg

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Drug-related adverse events
3
6.Secondary Outcome
Title Proportion of Participants With 50% Decrease in Tumor Marker
Hide Description Change in tumor marker CA19-9, assessed as a 50% decrease from baseline
Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pertuzumab Plus Erlotinib Hydrochloride
Hide Arm/Group Description:

Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks

Erlotinib hydrochloride 150 mg/day by mouth

Pertuzumab: iv, 840 mg, 420 mg

Erlotinib: PO, 150 mg

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pertuzumab Plus Erlotinib Hydrochloride
Hide Arm/Group Description

Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks

Erlotinib hydrochloride 150 mg/day by mouth

Pertuzumab: iv, 840 mg, 420 mg

Erlotinib: PO, 150 mg

All-Cause Mortality
Pertuzumab Plus Erlotinib Hydrochloride
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pertuzumab Plus Erlotinib Hydrochloride
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pertuzumab Plus Erlotinib Hydrochloride
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Gastrointestinal disorders   
Diarrhea  2  1/1 (100.00%)  1
General disorders   
Fatigue  1  1/1 (100.00%)  1
Fever  2  1/1 (100.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v3
2
Term from vocabulary, CTCAE 3
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: George Albert Fisher, MD
Organization: Stanford University Medical Center
Phone: 650-725-9057
EMail: georgeaf@stanford.edu
Layout table for additonal information
Responsible Party: George Albert Fisher, Stanford University
ClinicalTrials.gov Identifier: NCT01108458     History of Changes
Other Study ID Numbers: IRB-18227
SU-03082010-5163 ( Other Identifier: Stanford University )
PANC0010 ( Other Identifier: OnCore )
First Submitted: April 20, 2010
First Posted: April 22, 2010
Results First Submitted: January 12, 2017
Results First Posted: March 3, 2017
Last Update Posted: March 3, 2017