Study to Assess Pharmacokinetics, Immunogenicity and Safety/Tolerability of Patritumab (U3-1287)

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

The purpose of this study is to assess the PK, safety, and tolerability of patritumab produced by a new manufacturing process (denoted as "Process 2 patritumab"). The data from this study will allow Process 2 patritumab to be compared to Process 1 patritumab to allow for any dose adjustments, if needed, and to bridge data from studies previously conducted with Process 1 patritumab to studies to be conducted with Process 2 patritumab. The hypothesis for this study is that the pharmacokinetics of Process 2 patritumab will be comparable to those of Process 1 patritumab.

Key facts

Study ID

NCT01957280

Run by

Daiichi Sankyo

People needed

17

Starts

2013-06-01

Expected to finish

2014-04-01

Last updated by the study team

2014-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• 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.
• Must have an ECOG performance status of ≤ 2
• Women must be one of the following:
• Postmenopausal (having had no menstrual period for a minimum of 12 months) or surgically sterile, or
• 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.
• 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.
• Have hematological function, as follows:6. Men
• Absolute neutrophil count of ≥ 1.5 × 109/L
• Platelet count ≥ 100 × 109/L
• Hemoglobin ≥ 9 g/dL
• Have renal function, as follows:
• Calculated creatinine clearance rate (CrCl) ≥ 60 mL/minute using the modified Cockcroft-Gault equation or serum creatinine ≤ 1.5 × ULN.
• Have hepatic function, as follows:
• AST ≤ 2.5 × ULN (if liver metastases are present, < 5 × ULN)
• ALT ≤ 2.5 × ULN (if liver metastases are present, < 5 × ULN)
• Alkaline phosphatase ≤ 2.5 × ULN (if bone or liver metastases are present, < 5 × ULN)
• Bilirubin ≤ 1.5 × ULN
• Prothrombin time (PT) or partial thromboplastin time (PTT) ≤ 1.5 × ULN

You may not qualify if…

• Have a history of lymphoma, leukemia, or other hematopoietic malignancy.
• Have Have autologous or allogeneic stem cell transplant.
• Have any comorbid medical condition that would increase the risk of toxicity in the opinion of the investigator or sponsor.
• Have untreated or symptomatic brain metastasis.
• 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).
• 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 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 ascites or pleural effusion requiring chronic medical intervention.
• Have a history of bleeding diathesis.
• 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.
• Use of amiodarone within 6 months prior to enrollment.
• Concurrent use of antiarrhythmic medications with the exception of beta blockers for treatment of hypertension.
• Subjects who are receiving drugs that may affect QTc (e.g., quinidine or moxifloxacin).
• 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 a LVEF < 50%.
• Have anthracycline exposure greater than 360 mg/m2.
• Have a history of chronic hepatitis or known active infection with hepatitis B virus or hepatitis C virus.
• Personal or family history of long-QT syndrome.
• Have known infection with or a history of testing positive for human immunodeficiency virus (HIV).
• 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.
• 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 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 participated in clinical drug trials within 4 weeks before enrollment.
• Have had major surgery within 4 weeks before enrollment.
• Is currently participating in other investigational procedures.

Where it is running

• Study site — Tampa, Florida, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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