Recruitment

Recruitment Status
Completed

Inclusion Criterias

Must have an ECOG performance status of ≤ 2
AST ≤ 2.5 × ULN (if liver metastases are present, < 5 × ULN)
Postmenopausal (having had no menstrual period for a minimum of 12 months) or surgically sterile, or
...
Must have an ECOG performance status of ≤ 2
AST ≤ 2.5 × ULN (if liver metastases are present, < 5 × ULN)
Postmenopausal (having had no menstrual period for a minimum of 12 months) or surgically sterile, or
Prothrombin time (PT) or partial thromboplastin time (PTT) ≤ 1.5 × ULN
If of childbearing potential, must have been willing to use maximally effective birth control during the period of therapy and use contraception for 6 months following the last investigational drug infusion and must have had a negative urine or serum pregnancy test upon entry into the study.
Must have a pathologically documented advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available, or for which the subject refuses standard therapy.
Platelet count ≥ 100 × 109/L
Must have a tumor type that is known to express HER3. These tumors include breast, lung, prostate, ovarian, cervical, endometrial, gastric, pancreatic, bladder, head and neck, liver, colon, and esophageal cancer. Other tumors will be considered based on emerging HER3 expression data.
Calculated creatinine clearance rate (CrCl) ≥ 60 mL/minute using the modified Cockcroft-Gault equation or serum creatinine ≤ 1.5 × ULN.
Men must be surgically sterile or willing to use a double-barrier contraception method upon enrollment, during the course of the study, and for 6 months following the last investigational drug infusion.
ALT ≤ 2.5 × ULN (if liver metastases are present, < 5 × ULN)
Must be competent and able to comprehend, sign, and date an IRB-approved ICF (including HIPAA authorization, if applicable) before performance of any study-specific procedures or tests.
Bilirubin ≤ 1.5 × ULN
Hemoglobin ≥ 9 g/dL
Alkaline phosphatase ≤ 2.5 × ULN (if bone or liver metastases are present, < 5 × ULN)
Absolute neutrophil count of ≥ 1.5 × 109/L

Exclusion Criterias

Have had major surgery within 4 weeks before enrollment.
Have a history of chronic hepatitis or known active infection with hepatitis B virus or hepatitis C virus.
Have ascites or pleural effusion requiring chronic medical intervention.
...
Have had major surgery within 4 weeks before enrollment.
Have a history of chronic hepatitis or known active infection with hepatitis B virus or hepatitis C virus.
Have ascites or pleural effusion requiring chronic medical intervention.
Has any disorder that compromised the ability of the subject to give written informed consent and/or comply with study procedures.
Have any comorbid medical condition that would increase the risk of toxicity in the opinion of the investigator or sponsor.
Have concurrent or previous (within 1 week of study Day 1) anticoagulation therapy, except low-dose warfarin (≤ 2 mg/day) or low-dose, low-molecular weight heparin for prophylaxis against central venous catheter thrombosis or deep vein thrombosis.
Have Have autologous or allogeneic stem cell transplant.
Is currently participating in other investigational procedures.
Personal or family history of long-QT syndrome.
Have uncontrolled hypertension (diastolic blood pressure > 100 mmHg or systolic blood pressure > 140 mmHg). It is permissible for the subject to receive treatment with antihypertensive medication to maintain blood pressure within the required parameters.
Have a LVEF < 50%.
Have a history of bleeding diathesis.
Concurrent use of antiarrhythmic medications with the exception of beta blockers for treatment of hypertension.
Has previously received an anti-HER3 targeted antibody, including patritumab.
QTc interval > 450 msec on the average of the triplicate readings by Friderica's formula on 2 successive screening measurements (second measurement is required if first measurement is > 450 msec).
Have clinically significant ECG changes that obscure the ability to assess the RR, PR, QT, QT interval corrected for heart rate (QTc), and QRS interval. Subjects with left bundle branch block, atrial fibrillation and use of cardiac pacemaker specifically will be excluded.
Have a history of lymphoma, leukemia, or other hematopoietic malignancy.
Has known sensitivity to any of the products to be administered during dosing or known allergy to the excipients or investigational drugs.
Had therapeutic or palliative radiation therapy within 4 weeks before enrollment (in addition, he/she must have had resolution of any significant AEs from radiation therapy at least 2 weeks before enrollment).
Have unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE Version 4.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria with the exception of alopecia. Subjects with irreversible Grade 2 toxicity may be eligible as per discretion of the investigator and sponsor (e.g., Grade 2 chemotherapy-induced neuropathy).
Has active infection within 2 weeks before enrollment unless there was a discussion with the sponsor and an agreement was reached that the recent infection would not affect the subject's participation in the study.
Have untreated or symptomatic brain metastasis.
Subjects who are receiving drugs that may affect QTc (e.g., quinidine or moxifloxacin).
Use of amiodarone within 6 months prior to enrollment.
Have participated in clinical drug trials within 4 weeks before enrollment.
Had treatment with anticancer therapy (6 weeks for nitrosoureas and mitomycin C chemotherapies and 2 weeks for small molecule tyrosine kinase inhibitors), antibody therapy, retinoid therapy, or hormonal therapy within 4 weeks before study Day 1. Prior and concurrent use of hormone replacement therapy or the use of gonadotropin releasing hormone modulators for prostate cancer is permitted.
Have anthracycline exposure greater than 360 mg/m2.
Have known infection with or a history of testing positive for human immunodeficiency virus (HIV).
Have had a myocardial infarction within 1 year before enrollment, symptomatic CHF (New York Heart Association > Class II;), unstable angina, or unstable cardiac arrhythmia requiring medication.

Summary

Conditions
Solid Tumors
Type
Interventional
Phase
Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Process 2 patritumab will be administered intravenously as a single, loading dose of 18 mg/kg over approximately 60 minutes at Cycle 1 Day 1 followed by 9 mg/kg administered every 21 days as a maintenance dose starting at Cycle 2 Day 1. This study will be conducted in 2 phases: a main study and an e...

Process 2 patritumab will be administered intravenously as a single, loading dose of 18 mg/kg over approximately 60 minutes at Cycle 1 Day 1 followed by 9 mg/kg administered every 21 days as a maintenance dose starting at Cycle 2 Day 1. This study will be conducted in 2 phases: a main study and an extension phase. The PK profile of Process 2 patritumab will be compared to historical data for Process 1 patritumab. Specifically, the PK parameters (AUC0-21d and Cmax as primary endpoints) for Process 2 patritumab 18 mg/kg (loading dose) will be compared to the PK parameters of Process 1 patritumab 18 mg/kg. Process 2 patritumab serum concentrations will be compared to Process 1 patritumab serum concentrations collected in the Phase 1 and Phase 2 studies by population PK methods and will be reported separately.

Inclusion Criterias

Must have an ECOG performance status of ≤ 2
AST ≤ 2.5 × ULN (if liver metastases are present, < 5 × ULN)
Postmenopausal (having had no menstrual period for a minimum of 12 months) or surgically sterile, or
...
Must have an ECOG performance status of ≤ 2
AST ≤ 2.5 × ULN (if liver metastases are present, < 5 × ULN)
Postmenopausal (having had no menstrual period for a minimum of 12 months) or surgically sterile, or
Prothrombin time (PT) or partial thromboplastin time (PTT) ≤ 1.5 × ULN
If of childbearing potential, must have been willing to use maximally effective birth control during the period of therapy and use contraception for 6 months following the last investigational drug infusion and must have had a negative urine or serum pregnancy test upon entry into the study.
Must have a pathologically documented advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available, or for which the subject refuses standard therapy.
Platelet count ≥ 100 × 109/L
Must have a tumor type that is known to express HER3. These tumors include breast, lung, prostate, ovarian, cervical, endometrial, gastric, pancreatic, bladder, head and neck, liver, colon, and esophageal cancer. Other tumors will be considered based on emerging HER3 expression data.
Calculated creatinine clearance rate (CrCl) ≥ 60 mL/minute using the modified Cockcroft-Gault equation or serum creatinine ≤ 1.5 × ULN.
Men must be surgically sterile or willing to use a double-barrier contraception method upon enrollment, during the course of the study, and for 6 months following the last investigational drug infusion.
ALT ≤ 2.5 × ULN (if liver metastases are present, < 5 × ULN)
Must be competent and able to comprehend, sign, and date an IRB-approved ICF (including HIPAA authorization, if applicable) before performance of any study-specific procedures or tests.
Bilirubin ≤ 1.5 × ULN
Hemoglobin ≥ 9 g/dL
Alkaline phosphatase ≤ 2.5 × ULN (if bone or liver metastases are present, < 5 × ULN)
Absolute neutrophil count of ≥ 1.5 × 109/L

Exclusion Criterias

Have had major surgery within 4 weeks before enrollment.
Have a history of chronic hepatitis or known active infection with hepatitis B virus or hepatitis C virus.
Have ascites or pleural effusion requiring chronic medical intervention.
...
Have had major surgery within 4 weeks before enrollment.
Have a history of chronic hepatitis or known active infection with hepatitis B virus or hepatitis C virus.
Have ascites or pleural effusion requiring chronic medical intervention.
Has any disorder that compromised the ability of the subject to give written informed consent and/or comply with study procedures.
Have any comorbid medical condition that would increase the risk of toxicity in the opinion of the investigator or sponsor.
Have concurrent or previous (within 1 week of study Day 1) anticoagulation therapy, except low-dose warfarin (≤ 2 mg/day) or low-dose, low-molecular weight heparin for prophylaxis against central venous catheter thrombosis or deep vein thrombosis.
Have Have autologous or allogeneic stem cell transplant.
Is currently participating in other investigational procedures.
Personal or family history of long-QT syndrome.
Have uncontrolled hypertension (diastolic blood pressure > 100 mmHg or systolic blood pressure > 140 mmHg). It is permissible for the subject to receive treatment with antihypertensive medication to maintain blood pressure within the required parameters.
Have a LVEF < 50%.
Have a history of bleeding diathesis.
Concurrent use of antiarrhythmic medications with the exception of beta blockers for treatment of hypertension.
Has previously received an anti-HER3 targeted antibody, including patritumab.
QTc interval > 450 msec on the average of the triplicate readings by Friderica's formula on 2 successive screening measurements (second measurement is required if first measurement is > 450 msec).
Have clinically significant ECG changes that obscure the ability to assess the RR, PR, QT, QT interval corrected for heart rate (QTc), and QRS interval. Subjects with left bundle branch block, atrial fibrillation and use of cardiac pacemaker specifically will be excluded.
Have a history of lymphoma, leukemia, or other hematopoietic malignancy.
Has known sensitivity to any of the products to be administered during dosing or known allergy to the excipients or investigational drugs.
Had therapeutic or palliative radiation therapy within 4 weeks before enrollment (in addition, he/she must have had resolution of any significant AEs from radiation therapy at least 2 weeks before enrollment).
Have unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE Version 4.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria with the exception of alopecia. Subjects with irreversible Grade 2 toxicity may be eligible as per discretion of the investigator and sponsor (e.g., Grade 2 chemotherapy-induced neuropathy).
Has active infection within 2 weeks before enrollment unless there was a discussion with the sponsor and an agreement was reached that the recent infection would not affect the subject's participation in the study.
Have untreated or symptomatic brain metastasis.
Subjects who are receiving drugs that may affect QTc (e.g., quinidine or moxifloxacin).
Use of amiodarone within 6 months prior to enrollment.
Have participated in clinical drug trials within 4 weeks before enrollment.
Had treatment with anticancer therapy (6 weeks for nitrosoureas and mitomycin C chemotherapies and 2 weeks for small molecule tyrosine kinase inhibitors), antibody therapy, retinoid therapy, or hormonal therapy within 4 weeks before study Day 1. Prior and concurrent use of hormone replacement therapy or the use of gonadotropin releasing hormone modulators for prostate cancer is permitted.
Have anthracycline exposure greater than 360 mg/m2.
Have known infection with or a history of testing positive for human immunodeficiency virus (HIV).
Have had a myocardial infarction within 1 year before enrollment, symptomatic CHF (New York Heart Association > Class II;), unstable angina, or unstable cardiac arrhythmia requiring medication.

Locations

Tampa, Florida, 33612
San Antonio, Texas, 78229
Oklahoma City, Oklahoma, 73104
Tampa, Florida, 33612
San Antonio, Texas, 78229
Oklahoma City, Oklahoma, 73104

Tracking Information

NCT #
NCT01957280
Collaborators
Not Provided
Investigators
Not Provided