Philippine Health Research Registry
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DATA ELEMENT
BEFORE(2017-01-26 14:45:11)
AFTER(2017-01-26 16:08:39)
 
BASIC INFORMATION
 
 
<primary_outcomes>
 

 

 

 

Primary objective


Compare the overall response rate (ORR) of MYL-1402O with that of

 

 

Avastin, in combination with CP chemotherapy during the first

18 weeks of first-line treatment in patients with Stage IV nsNSCLC
 

 

 

 

Primary objective


Compare the overall response rate (ORR) of MYL-1402O with that of

 

 

Avastin, in combination with CP chemotherapy during the first

18 weeks of first-line treatment in patients with Stage IV nsNSCLC
 
<key_criteria>
 
 

Inclusion Criteria

 

A patient is eligible for inclusion in the study if he or she meets all of

the following criteria:

1. Has demonstrated the ability to understand verbal and/or written

instructions, to provide written informed consent, and is capable

and agreeable to comply with protocol requirements.

2. Male or female at least 18 years of age at the time of signing an

informed consent form (ICF).

3. Has a documented imaging diagnosis of Stage IV unresectable,

recurrent or metastatic nsNSCLC.

4. Has documented histologic or cytologic diagnosis of advanced

nsNSCLC with negative or unknown sensitizing epidermal growth

factor receptor (EGFR) mutation, and negative or unknown

echinoderm microtubule-associated protein-like 4-anaplastic

lymphoma kinase (EML4-ALK) rearrangement.

5. Has measurable disease with at least 1 measurable lesion as

defined by Response Evaluation Criteria in Solid Tumors

(RECIST 1.1; Section 12.1 [Appendix A]). All target (up to

5 lesions) and nontarget lesions (other measurable not included in

target, nonmeasurable, nonevaluable, or evaluable lesions) should

be included in the assessment or evaluation of disease response as

defined by RECIST 1.1 (Eisenhauer et al 2009).

6. Has a performance status of 0 or 1 on the Eastern Cooperative

Oncology Group (ECOG) scale.

7. Has at least 6 months of expected survival.

8. Has not received any prior systemic therapy for first-line treatment

of advanced lung cancer, except adjuvant chemotherapy, and

remained disease-free for at least 12 months from time of surgery,

and at least 6 months from last dose of chemotherapy.

9. May have had prior radiation therapy provided <25% of bone

marrow is involved (Section 12.3 [Appendix C]), except for

previous mediastinal irradiation that is not allowed.

a. Prior radiation therapy must have been completed at least

2 weeks prior to Day 0 of Cycle 1

b. Patient must have recovered from acute toxicities associated

with radiation therapy. Radiation-related toxicities must have

resolved to Grade 1 according to the National Cancer Institute

Common Terminology Criteria for Adverse Events (CTCAE;

version 4.03) grade prior to Day 0 of Cycle 1.

10. May have brain metastasis provided the metastasis has been

treated and is considered stable at the time of signing the informed

consent form. Treated, stable brain metastasis is defined as:

a. Metastasis having no evidence of progressive disease (PD) or

hemorrhage after treatment.

b. No ongoing requirement for dexamethasone, as ascertained byclinical examination and post-treatment brain imaging

(computed tomography [CT] scan or magnetic resonance

imaging [MRI]) at baseline.

c. Anticonvulsants are allowed, provided the dose regimen has

been unchanged (stable) for at least 2 weeks prior to patient

signing informed consent.

d. Treatment for brain metastasis may include whole brain

radiotherapy, radiosurgery (Gamma Knife®, linear particle

accelerator, or equivalent), or a combination thereof, as

deemed appropriate by the treating physician. All brain

metastasis treatments must be completed at least 14 days prior

to Day 0 of Cycle 1.

11. Has adequate organ functions based on the following:

a. Bone marrow reserve:

i. White blood cell count ≥3 × 10

3

/µL;

ii. Absolute neutrophil count (segmented and bands)

≥1.5 × 10

3

/µL;

iii. Platelet count ≥100 × 10

3

/µL;

iv. Hemoglobin ≥9.0 g/dL with at least 2 weeks without

transfusions before Day 0 of Cycle 1.

b. Hepatic:

i. Total bilirubin ≤1.5 × upper limit of normal (ULN); except

if elevation is due to Gilbert’s Syndrome with transitory

elevations of indirect bilirubin.

ii. Alkaline phosphatase, alanine transaminase, and/or

aspartate transaminase ≤3 × ULN. Significant levels of

alanine transaminase or aspartate transaminase should be

further assessed for viral hepatitis. (Note: Isolated alkaline

phosphatase elevation beyond 3 × ULN due to bone

metastasis is allowed).

c. Renal:

i. Calculated creatinine clearance ≥45 mL/min based on the

original, weight-based Cockcroft and Gault formula

(Cockcroft and Gault 1976; Section 12.4 [Appendix D])

ii. Urine protein to creatinine ratio ≤1. A patient with urine

protein to creatinine ratio > 1 may be enrolled if ≤2g of

protein in 24-hour urine collection.

12. If capable of reproduction, patients and their partners must use

contraceptive methods during the full duration of the study and for6 months after discontinuation of study.

A patient who is capable of reproduction must be willing to

practice birth control by using 2 different highly effective double

barrier methods of contraception, or abstinence from sexual

intercourse for the duration of the study.

In particular a female patient of childbearing potential must use amethod that results in less than 1% failure rate per year when useconsistently and correctly such as implants, injectables, combined

oral contraceptives, intrauterine devices, sexual abstinence, or

vasectomized partner.

A male patient of reproductive potential (defined as a male that

has not had a vasectomy) must use a condom with spermicide and

their female partner to use another highly effective form of

contraception.

 

 

Exclusion Criteria

 

A patient who meets any of the following criteria will be excluded

from the study:

1. Is pregnant or breast-feeding.

2. Has documented histology/cytology confirming any of the

following:

a. Squamous non-small cell lung cancer. (Note: In the event of

mixed tumor histology/cytology or predominant cell type other

than non-squamous, eligibility will be determined based on the

predominant cell type, which must be non-squamous.)

b. A patient with any small cell type or large cell neuroendocrine

histology.

3. Has a recent (within 6 months prior to Day 0 of Cycle 1) cardiac

condition as defined by the New York Heart Association Class II,

III, or IV (AHA 1994).

4. Has a recent (within 6 months prior to Day 0 of Cycle 1) history of

a significant vascular event (such as aortic aneurysm requiring

surgical repair or a recent peripheral arterial thrombosis) and/or

history of significant and unstable vascular disease.

5. Has a history of stroke or transient ischemic attack within

6 months prior to Day 0 of Cycle 1, or has a long-term history of

more than one of the following vascular thromboembolic events:

a. Cerebrovascular accidents

b. Transient ischemic attacks

c. Myocardial infarctions

d. Venous thromboembolic reactions, including pulmonary

embolism

6. Is receiving anticoagulant therapy that:

a. Is not considered ‘stable’, defined as dosage not maintained

for at least 3 months prior to Day 0 of Cycle 1.

b. Is not within the targeted international normalized ratio at thetime of consent signing.

7. Has a current diagnosis, history, or risk of hemorrhage in the

central nervous system (CNS), including the following:

a. Patient with CNS metastasis treated by neurosurgical resection

or brain biopsy performed within 8 weeks prior to Day 0 of

Cycle 1.

b. Patient should be off corticosteroids for at least 1 week

(7 days) at the time of the post-treatment (for CNS metastasis)

brain CT/MRI.

8. Has any prior history of hypertensive crisis and/or

hypertensive encephalopathy, or has a current diagnosis or

recent history of inadequately controlled hypertension (defined

as systolic blood pressure >150 mm Hg and/or diastolic

>100 mm Hg, while on antihypertensive medications).

Has a recent history of any of the following:

a. A major surgical procedure, open biopsy, open pleurodesis, or

significant traumatic injury within 28 days prior to Day 0 of

Cycle 1.

b. Documented history of conditions that may need surgery

during the study or within 6 months of signing informed

consent.

c. Has had either a core biopsy or other minor surgical procedure

within 7 days prior to Day 0 of Cycle 1. (Note: Placement of a

vascular access device, or a closed pleurodesis, thoracentesis,

or mediastinoscopy are allowed).

10. Has a history of any of the following:

a. Hemoptysis (approximately >2.5 mL or a half teaspoon)

within 3 months prior to Day 0 of Cycle 1.

b. A thoracic, central, mediastinal tumor location in contact with

major vessels

c. A cavitated lung tumor.

11. Has a history of gastrointestinal fistula, perforation, or abscess.

12. Has a current diagnosis or history of a nonhealing wound, active

ulcer, or untreated bone fracture.

13. Has prior history of another active malignancy within the last

5 years, other than adequately treated superficial basal cell,

superficial/skin squamous cell carcinoma, or carcinomas in situ.

14. Has a known hypersensitivity to any component of carboplatin,

paclitaxel, bevacizumab, Chinese hamster ovary cell products, or

other recombinant human or humanized antibodies.

15. Has received treatment with any other investigational drug, within

the last 30 days or at least 5 half-lives (if available), whichever is

longer, should have elapsed prior to Day 0 of Cycle 1.

16. Has previously received treatment with the following:

a. Paclitaxel.

b. Bevacizumab (Note: Prior intravitreal administration of

bevacizumab does not preclude study participation).

c. Anthracycline. (Note: May be allowed on a case by case basis

after consulting with the medical monitor to rule out an

increased risk of cardiac failure).

17. Has documented or known current alcohol/drug abuse that

precludes his/her ability to adhere to the protocol.

18. Has any of the following concomitant treatments or conditions:

a. Concomitant vaccination that contains an attenuated virus, for

instance Yellow Fever vaccine.

b. Has a known history of active or latent tuberculosis.

c. Has a concomitant systemic disorder (e.g., active infection

including known human immunodeficiency virus, viral

hepatitis B or C) that, in the opinion of the principal

investigator (PI; or designee), would compromise the patient's

safety (for instance potential drug interactions, or ability to

adhere to the protocol).

d. Has any other concomitant condition that precludes the

participation in the study through increased risk to the patient

and/or potential to impact the PI’s (or designee’s) ability to

administer this protocol.
 
<study_type>
 
 Interventional
 
<intervention_name>
 
 MYL-1402O (test product)
 
<intervention_description>
 
 

Mylan GmbH will provide adequate supplies of interventional therapies (MYL-1402O,

Avastin, carboplatin, and paclitaxel). Chemotherapy pre-medications and any other

medications will be procured locally by the site. Sites will also provide the infusion supplies

from their stock. For this protocol, carboplatin and paclitaxel are considered non-investigational.

 

MYL-1402O (test product) and Avastin (reference product) will be packaged, labelled and

supplied centrally to all sites from the Mylan-approved packaging vendor.

The CP chemotherapy will be administered sequentially after IMP. This will also be

packaged, labelled, and supplied centrally to all sites from the Mylan approved packaging

vendor.

MYL-1402O and Avastin vials are not blinded. Each vial will be labelled with a blinded label

as per local language and regulatory requirement. Each individual vial will then be placed

into a labelled carton. The carton will have a blinded label applied to it. Once the vial is

placed into the carton and tamper sealed, it is then blinded.

 
<allocation_method>
 
 Randomized
 
<masking>
 
 Double Blind
 
<assignment>
 
 Parallel
 
<purpose>
 
 

The primary objective of this study is to compare the ORR of MYL-1402O with that of

Avastin, in combination with CP chemotherapy during the first 18 weeks of first-line

treatment in patients diagnosed with Stage IV nsNSCLC.

 
<reason_phils_sample_difference>
 
 N/A, not yet recruiting
 
COUNTRIES OF RECRUITMENT
 
 
FUNDING AGENCIES
 
 
IMPLEMENTING AGENCIES
 
 
INVESTIGATING TEAMS
 
 
IP PROTECTIONS
 
 
AMENDMENTS
 
 
OLD AMENDMENTS
 
 
PROJECT LOCATIONS
 
 
SCIENTIFIC QUERY CONTACT
 
 
PUBLIC QUERY CONTACT
 
 
PROJECT STATUS
 
 
SECONDARY SPONSORS
 
 
RESEARCH UTILIZATIONS