Trial Outcomes & Findings for A Phase 2 Study of Pertuzumab and Erlotinib for Refractory Pancreatic Adenocarcinoma (NCT NCT01108458)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

CT imaging every 9 weeks while on protocol

Results posted on

2017-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	Pertuzumab Plus Erlotinib Hydrochloride 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 Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Pertuzumab Plus Erlotinib Hydrochloride 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 Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pertuzumab Plus Erlotinib Hydrochloride n=1 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Gender Female	0 Participants n=5 Participants
Gender Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: CT imaging every 9 weeks while on protocol

Outcome measures

Outcome measures
Measure	Pertuzumab Plus Erlotinib Hydrochloride 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 Response Rate by RECIST Criteria	0

SECONDARY outcome

Timeframe: 9 weeks

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.

Outcome measures

Outcome measures
Measure	Pertuzumab Plus Erlotinib Hydrochloride 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
Progression-free Survival (PFS)	0

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	Pertuzumab Plus Erlotinib Hydrochloride 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 Survival (OS)	0

SECONDARY outcome

Timeframe: 3 weeks

Quality of life as assessed by EORTC QLQ-C30 questionnaire

Outcome measures

Outcome measures
Measure	Pertuzumab Plus Erlotinib Hydrochloride 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
Quality of Life (QoL)	0

SECONDARY outcome

Timeframe: 3 weeks

Number of incidences of serious and non-serious drug-related adverse events

Outcome measures

Outcome measures
Measure	Pertuzumab Plus Erlotinib Hydrochloride n=1 Participants 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
No. of Events of Drug-related Toxicity	3 Drug-related adverse events

SECONDARY outcome

Timeframe: 3 weeks

Change in tumor marker CA19-9, assessed as a 50% decrease from baseline

Outcome measures

Outcome measures
Measure	Pertuzumab Plus Erlotinib Hydrochloride 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
Proportion of Participants With 50% Decrease in Tumor Marker	0

Adverse Events

Pertuzumab Plus Erlotinib Hydrochloride

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pertuzumab Plus Erlotinib Hydrochloride n=1 participants at risk 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
General disorders Fatigue	100.0% 1/1 • Number of events 1
Gastrointestinal disorders Diarrhea	100.0% 1/1 • Number of events 1
General disorders Fever	100.0% 1/1 • Number of events 1

Additional Information

George Albert Fisher, MD

Stanford University Medical Center

Phone: 650-725-9057

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place