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

NCT01957280 | Completed Phase 1 DMC

• 1 other identifier: U31287-A-U105
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Solid Tumors

Keywords

HER3

Outcome Measures

Primary Outcomes (2)

• AUC (0-21 day) of Patritumab

  AUC (0-21 day) of patritumab obtained after a single infusion of Process 2 patritumab 18 mg/kg (loading dose)

  5 Cycles, each of which lasts 21 Days

• Cmax of Patritumab

  Cmax of patritumab obtained after a single infusion of Process 2 patritumab 18 mg/kg (loading dose)

  5 Cycles, each of which lasts 21 Days

Secondary Outcomes (12)

• volume of distribution [Vz]

  5 Cycles, each of which lasts 21 Days

• Safety and Tolerability of Process 2 patritumab - (electrocardiograms [ECG)

  5 Cycles, each of which lasts 21 Days

• Antibody Formation

  5 Cycles, each of which lasts 21 Days

• Concentration patritumab at 504 hours

  5 Cycles, each of which lasts 21 Days

• AUC to infinity [AUC0-inf]

  5 Cycles, each of which lasts 21 Days

Study Arms (1)

Process 2 patritumab

EXPERIMENTAL

Process 2 patritumab 18 mg/kg (loading dose) on Day 1 of Cycle 1 followed by Process 2 patritumab 9 mg/kg (maintenance dose) once every 21 days starting on Day 1 of Cycle 2 through Cycle 5.

Drug: patritumab

Interventions

patritumab DRUG

Also known as: U3-1287

Process 2 patritumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

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 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.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (3)

Unknown Facility

Tampa, Florida, 33612, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 73104, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

patritumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: October 8, 2013
• Study Start: June 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: April 1, 2014
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

US (3)