Safety of AMG 706 Plus Panitumumab Plus Gemcitabine-Cisplatin in the Treatment of Patients With Advanced Cancer

Amgen

Status and phase: Terminated; Phase 1

Conditions: Esophageal Cancer; Lung Cancer; Pancreatic Cancer

Treatments: Drug: Gemcitabine; Drug: AMG 706; Biological: Panitumumab; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00101907

20040206

Details and patient eligibility

About

The purpose of this study is to characterize the safety and tolerability of AMG 706 plus panitumumab when administered with gemcitabine and cisplatin chemotherapy. This is a Phase 1b clinical study.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For complete inclusion and exclusion, please refer to the investigator.

Inclusion Criteria:

• Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved informed consent form
• Subjects with advanced cancer in whom the gemcitabine and cisplatin chemotherapy regimen is clinically indicated
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate hematological function
• Adequate renal function
• Adequate hepatic function
• Life expectancy of greater than or equal to 3 months as documented by the investigator

Exclusion Criteria:

• More than 1 prior chemotherapy regimen
• History of venous thrombosis
• Myocardial infarction, cerebrovascular accident, transient ischemic attack, percutaneous transluminal coronary angioplasty/stent, or unstable angina within 1 year before study enrollment
• History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on screening chest computed tomograph (CT) scan
• Average systolic blood pressure of greater than 145 mm Hg or average diastolic blood pressure of greater than 85 mm Hg
• Radiotherapy within 28 days of study enrollment or within 14 days of study enrollment for peripheral lesions
• Prior AMG 706, panitumumab, or another anti-EGFr monoclonal antibody (mAb) (e.g., cetuximab [Erbitux®] or EMD 72000)
• Systemic chemotherapy within 28 days before study enrollment
• Major surgery within 28 days or minor surgery within 14 days of study enrollment
• Central nervous system metastases (Exception: subjects with treated asymptomatic central nervous system metastases, those who have been clinically stable in the judgment of the investigator and off steroids for at least 30 days before the study enrollment are eligible)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 6 patient groups

Panitumumab + Gem/Cis

Experimental group

Description:

Panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle.

Treatment:

Biological: Panitumumab

Drug: Cisplatin

Drug: Gemcitabine

50 mg QD AMG 706 + panitumumab + Gem/Cis

Experimental group

Description:

AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle.

Treatment:

Biological: Panitumumab

Drug: Cisplatin

Drug: AMG 706

Drug: Gemcitabine

75 mg QD AMG 706 + panitumumab + Gem/Cis

Experimental group

Description:

AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle.

Treatment:

Biological: Panitumumab

Drug: Cisplatin

Drug: AMG 706

Drug: Gemcitabine

100 mg QD AMG 706 + panitumumab + Gem/Cis

Experimental group

Description:

AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle.

Treatment:

Biological: Panitumumab

Drug: Cisplatin

Drug: AMG 706

Drug: Gemcitabine

125 mg QD AMG 706 + panitumumab + Gem/Cis

Experimental group

Description:

AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle.

Treatment:

Biological: Panitumumab

Drug: Cisplatin

Drug: AMG 706

Drug: Gemcitabine

75 mg BID AMG 706 + panitumumab + Gem/Cis

Experimental group

Description:

AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle.

Treatment:

Biological: Panitumumab

Drug: Cisplatin

Drug: AMG 706

Drug: Gemcitabine