Trial Outcomes & Findings for A Phase II Study of Pertuzumab and Erlotinib for Metastatic or Unresectable Neuroendocrine Tumors (NCT NCT00947167)

NCT ID: NCT00947167

Last Updated: 2017-03-03

Results Overview

RECIST v1.1 used

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 4 participants
• Primary outcome timeframe: CT scans are done every 4 cycles (every 12 wks)
• Results posted on: 2017-03-03

Participant Flow

Participant milestones

Measure	Pertuzumab and Erlotinib pertuzumab: 840 mg, 420 mg, iv erlotinib: 150 mg, PO
Pertuzumab Alone STARTED	4
Pertuzumab Alone COMPLETED	4
Pertuzumab Alone NOT COMPLETED	0
Erlotinib Added to Pertuzumab STARTED	3
Erlotinib Added to Pertuzumab COMPLETED	3
Erlotinib Added to Pertuzumab NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase II Study of Pertuzumab and Erlotinib for Metastatic or Unresectable Neuroendocrine Tumors

Baseline characteristics by cohort

Measure	Pertuzumab and Erlotinib n=4 Participants pertuzumab: 840 mg, 420 mg, iv erlotinib: 150 mg, PO
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	46.5 years n=5 Participants
Gender Female	2 Participants n=5 Participants
Gender Male	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: CT scans are done every 4 cycles (every 12 wks)

Population: whole cohort

RECIST v1.1 used

Outcome measures

Measure	Pertuzumab and Erlotinib n=4 Participants pertuzumab: 840 mg, 420 mg, iv erlotinib: 150 mg, PO
Response Rate (RR) for All Patients Treated With This Strategy (Simon Design)	0 Participants

SECONDARY outcome

Timeframe: AEs are assessed every cycle (every 3 wks)

Population: whole cohort

by CTCAE

Outcome measures

Measure	Pertuzumab and Erlotinib n=4 Participants pertuzumab: 840 mg, 420 mg, iv erlotinib: 150 mg, PO
Toxicities Assessed by CTCAE Grading Criteria and Assigned Attributions Accordingly	4 Participants

Adverse Events

Pertuzumab and Erlotinib

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pertuzumab and Erlotinib n=4 participants at risk pertuzumab: 840 mg, 420 mg, iv erlotinib: 150 mg, PO
Blood and lymphatic system disorders Hemoglobin	75.0% 3/4 • Number of events 3 • 4 years We followed patients until death
Blood and lymphatic system disorders Leukocytes	25.0% 1/4 • Number of events 1 • 4 years We followed patients until death
Blood and lymphatic system disorders Platelets	25.0% 1/4 • Number of events 1 • 4 years We followed patients until death
General disorders Fatigue	100.0% 4/4 • Number of events 4 • 4 years We followed patients until death
General disorders Sweating	25.0% 1/4 • Number of events 1 • 4 years We followed patients until death
Skin and subcutaneous tissue disorders Hair loss	25.0% 1/4 • Number of events 1 • 4 years We followed patients until death
Skin and subcutaneous tissue disorders Rash	100.0% 4/4 • Number of events 4 • 4 years We followed patients until death
Gastrointestinal disorders Anorexia	50.0% 2/4 • Number of events 2 • 4 years We followed patients until death
Gastrointestinal disorders Diarrhea	100.0% 4/4 • Number of events 4 • 4 years We followed patients until death
Gastrointestinal disorders Mucositis	25.0% 1/4 • 4 years We followed patients until death
Gastrointestinal disorders Nausea	50.0% 2/4 • Number of events 2 • 4 years We followed patients until death
Gastrointestinal disorders Taste	25.0% 1/4 • Number of events 1 • 4 years We followed patients until death
Gastrointestinal disorders Vomiting	75.0% 3/4 • Number of events 3 • 4 years We followed patients until death
Gastrointestinal disorders Hemorrhage	25.0% 1/4 • Number of events 1 • 4 years We followed patients until death
Metabolism and nutrition disorders Albumin low	25.0% 1/4 • Number of events 1 • 4 years We followed patients until death
Metabolism and nutrition disorders Alkaline Phosphatase elevation	25.0% 1/4 • Number of events 1 • 4 years We followed patients until death
Metabolism and nutrition disorders ALT elevation	75.0% 3/4 • Number of events 3 • 4 years We followed patients until death
Metabolism and nutrition disorders AST elevation	50.0% 2/4 • Number of events 2 • 4 years We followed patients until death
Metabolism and nutrition disorders Calcium low	25.0% 1/4 • Number of events 1 • 4 years We followed patients until death
Metabolism and nutrition disorders Potassium low	25.0% 1/4 • Number of events 1 • 4 years We followed patients until death

Additional Information

Pamela L. Kunz, MD, Leader GI Oncology Research Group

Stanford University School of Medicine

Phone: 650-725-8738

Email: pkunz@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place