Solid TumorsPhase 1NCT01957280
Study to Assess Pharmacokinetics, Immunogenicity and Safety/Tolerability of Patritumab (U3-1287)
A Phase 1 study testing patritumab in people with Solid Tumors, run by Daiichi Sankyo at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- patritumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2013to Apr 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- 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.
Show all 29Show fewer
- 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.
- Has any disorder that compromised the ability of the subject to give written informed consent and/or comply with study procedures.
- Has known sensitivity to any of the products to be administered during dosing or known allergy to the excipients or investigational drugs.
- 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.
- Has previously received an anti-HER3 targeted antibody, including patritumab.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Oklahoma City, Oklahoma, 73104
Study site
San Antonio, Texas, 78229
Study site
Tampa, Florida, 33612
About this study
Official title: Phase 1, Open-label Study Assessing the Pharmacokinetics, Immunogenicity and Safety/Tolerability of Process 2 Patritumab in Patients With Advanced, Refractory Solid Tumors
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.
Read the detailed 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 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.
- Conditions
- Solid Tumors
- Being tested
- patritumab
- Keywords
- HER3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patritumabDrug
Also called U3-1287
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: patritumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 5 Cycles, each of which lasts 21 Days
Secondary outcomes (12)
volume of distribution [Vz]
To assess the secondary PK parameters volume of distribution [Vz]
Measured: 5 Cycles, each of which lasts 21 Days
Safety and Tolerability of Process 2 patritumab - (electrocardiograms [ECG)
To assess the safety and tolerability of Process 2 patritumab (electrocardiograms [ECG)
Measured: 5 Cycles, each of which lasts 21 Days
Antibody Formation
To characterize the formation of antibodies to patritumab human antihuman antibodies (HAHA) after infusion of Process 2 patritumab
Measured: 5 Cycles, each of which lasts 21 Days
Concentration patritumab at 504 hours
To assess the secondary PK parameter concentration of patritumab at 504h [C504]
Measured: 5 Cycles, each of which lasts 21 Days
AUC to infinity [AUC0-inf]
To assess the secondary PK parameters AUC to infinity [AUC0-inf]
Measured: 5 Cycles, each of which lasts 21 Days
time to Cmax (Tmax)
To assess the secondary PK parameters time to Cmax (Tmax)
Measured: 5 Cycles, each of which lasts 21 Days
concentration at the end of infusion (Ceoi)
To assess the secondary PK parameters concentration at the end of infusion (Ceoi)
Measured: 5 Cycles, each of which lasts 21 Days
terminal elimination half-life (t 1/2)
To assess the secondary PK parameters terminal elimination half-life (t 1/2)
Measured: 5 Cycles, each of which lasts 21 Days
clearance (CL)
To assess the secondary PK parameters clearance (CL)
Measured: 5 Cycles, each of which lasts 21 Days
trough concentration (Ctrough)
To assess the secondary PK parameters trough concentration (Ctrough)
Measured: 5 Cycles, each of which lasts 21 Days
echocardiograms/multi-gated acquisition [MUGA] scans of Process 2 patritumab
To assess the safety and tolerability of Process 2 patritumab echocardiograms/multi-gated acquisition [MUGA] scans
Measured: 5 Cycles, each of which lasts 21 Days
adverse events [AEs] of Process 2 patritumab
To assess the safety and tolerability of Process 2 patritumab adverse events [AEs] of Process 2 patritumab
Measured: 5 Cycles, each of which lasts 21 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957280
- Sponsor's protocol ID
- U31287-A-U105
- Status last verified
- May 2014
- First submitted
- 12 Jun 2013
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-label Study Assessing the Pharmacokinetics, Immunogenicity and Safety/Tolerability of Process 2 Patritumab in Patients With Advanced, Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT01957280
- Acronym / sponsor ID
- U31287-A-U105
- Conditions
- Solid Tumors
- Keywords
- HER3
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Process 2 patritumab | Experimental | Drug: patritumabProcess 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
Key exclusion criteria (29 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patritumabAlso: U3-1287 | Drug | Process 2 patritumab |
Primary outcome
AUC (0-21 day) of Patritumab
Time frame: 5 Cycles, each of which lasts 21 Days
AUC (0-21 day) of patritumab obtained after a single infusion of Process 2 patritumab 18 mg/kg (loading dose)
Cmax of Patritumab
Time frame: 5 Cycles, each of which lasts 21 Days
Cmax of patritumab obtained after a single infusion of Process 2 patritumab 18 mg/kg (loading dose)
12 secondary outcomes
volume of distribution [Vz]
Time frame: 5 Cycles, each of which lasts 21 Days
Safety and Tolerability of Process 2 patritumab - (electrocardiograms [ECG)
Time frame: 5 Cycles, each of which lasts 21 Days
Antibody Formation
Time frame: 5 Cycles, each of which lasts 21 Days
Concentration patritumab at 504 hours
Time frame: 5 Cycles, each of which lasts 21 Days
AUC to infinity [AUC0-inf]
Time frame: 5 Cycles, each of which lasts 21 Days
time to Cmax (Tmax)
Time frame: 5 Cycles, each of which lasts 21 Days
concentration at the end of infusion (Ceoi)
Time frame: 5 Cycles, each of which lasts 21 Days
terminal elimination half-life (t 1/2)
Time frame: 5 Cycles, each of which lasts 21 Days
clearance (CL)
Time frame: 5 Cycles, each of which lasts 21 Days
trough concentration (Ctrough)
Time frame: 5 Cycles, each of which lasts 21 Days
echocardiograms/multi-gated acquisition [MUGA] scans of Process 2 patritumab
Time frame: 5 Cycles, each of which lasts 21 Days
adverse events [AEs] of Process 2 patritumab
Time frame: 5 Cycles, each of which lasts 21 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
Related trials for Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing patritumab in people with Solid Tumors, run by Daiichi Sankyo at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (0-21 day) of Patritumab (time frame: 5 Cycles, each of which lasts 21 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2014.