A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Effect of RWJ-800088 on The Prevention of Chemotherapy-Induced Anemia and The Prevention of Chemotherapy-Induced Thrombocytopenia in Subjects with Non-Small Cell Lung Cancer Receiving Gemcitabine and Either Carboplatin or Cisplatin - n/a

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-007520-17-BE
• Date of registration: 30/06/2008
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International N.V, Turnhoutseweg 30, 2340 Beerse, Belgium
• Public title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Effect of RWJ-800088 on The Prevention of Chemotherapy-Induced Anemia and The Prevention of Chemotherapy-Induced Thrombocytopenia in Subjects with Non-Small Cell Lung Cancer Receiving Gemcitabine and Either Carboplatin or Cisplatin - n/a
• Scientific title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Effect of RWJ-800088 on The Prevention of Chemotherapy-Induced Anemia and The Prevention of Chemotherapy-Induced Thrombocytopenia in Subjects with Non-Small Cell Lung Cancer Receiving Gemcitabine and Either Carboplatin or Cisplatin - n/a
• Date of first enrolment: 25/07/2008
• Target sample size: 148
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007520-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Belgium

Key inclusion & exclusion criteria

Inclusion criteria:
1. Men or women, at least 18 years of age
2. Histologically confirmed diagnosis of stage IIIB or IV NSCLC
3. Presence of measurable disease per RECIST criteria
4. Candidate for up to 6 cycles of a 21-day chemotherapy regimen of gemcitabine and either carboplatin or cisplatin
5. Body weight > 40 kg
6. Hemoglobin =12.0 g/dL, but not exceeding the upper limit of the normal range, with:
a. No need for ESAs at randomization
b. No history of anemia due to factors other than cancer/chemotherapy (e.g., iron, B12 or folate deficiencies, hemolysis, or bleeding)
7. Neutrophil count within normal range
8. Platelet count within 100,000 to 450,000/µL
9. ECOG Performance Status of 0 or 1 (Attachment 7)
10. Creatinine clearance = 40 ml/min, per Cockroft-Gault formula Estimated creatinine clearance (ml/min) = [[140 - age(yr)]*weight(kg)]/[72*serum Cr(mg/dL)]
(multiply by 0.85 for women)
11. Negative serum ß human chorionic gonadotropin (ßhCG) in women of childbearing potential
12. Women must agree to not get pregnant during the study.
13. Men must agree to use a double barrier method of birth control and not donate sperm from the first dose of study drug through 30 days after receiving the last dose of study drug.
14. Willing to adhere to the prohibitions and restrictions specified in this protocol.
15. Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
16. To participate in the optional pharmacogenomic component of this study, subjects must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to consent for this component does not exclude a subject from participation in the clinical study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Central nervous system metastases; with the exception of a subject with stable brain metastases following stereotactic radiosurgery (gamma knife).
2. Prior treatment by systemic therapy or radiation for Stage IIIB or IV NSCLC
3. Prior (within 1 year) adjuvant or neoadjuvant therapy for NSCLC
4. Diagnosis of a myeloid malignancy or known history of myelodysplasia
5. Hemoptysis, or active bleeding
6. Planned nonpalliative radiation during the study. Palliative radiation is permitted, at the discretion of the investigator, if the area being treated is small (<15% of body surface area but no pelvic radiation is permitted or no more than 10% of the bone marrow reserve is irradiated).
7. Other malignancies within 5 years prior, except carcinoma in situ of the cervix, or non-melanoma skin cancer.
8. Systemic infection within the last 30 days or major infection requiring hospitalization and antibiotics within the last 14 days
9. History of thrombovascular event (TVE) within the past 2 years; evidence of acute thromboembolic event in the last 45 days
10. Transfusion of platelets or RBCs within 28 days before the planned first dose administration of study medication
11. Neuropathy > Grade 1
12. Currently receiving therapeutic or prophylactic heparin or low molecular weight heparin anticoagulants (warfarin is permitted) or anti-platelet therapy (aspirin and NSAIDS are permitted).
13. Use of growth factors (e.g. G-CSF, GM-CSF, erythropoietins) or IL-11 within 28 days prior to planned first dose of study drug.
14. Prior use of Avastin or Erbitux
15. Received an experimental drug or used an experimental medical device within 30 days prior to planned first dose of study drug administration.
16. Serology positive for hepatitis B surface antigen (HbsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV) antibodies.
17. History of life threatening allergic reactions to food or drugs,including those related to RWJ-800088 (e.g., AMG531, rh-TPO or PEG-MDGF).
18. Major surgery within 30 days prior to Screening visit and/or planned surgery
with a risk of blood loss.
19. Employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator.




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chemotherapy induced anaemia and chemotherapy induced thrombocytopenia
MedDRA version: 9.1 Level: LLT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB
MedDRA version: 9.1 Level: LLT Classification code 10029522 Term: Non-small cell lung cancer stage IV
MedDRA version: 9.1 Level: LLT Classification code 10039884 Term: Secondary thrombocytopenia
MedDRA version: 9.1 Level: LLT Classification code 10054606 Term: Secondary anemia

Intervention(s)

Product Name: RWJ-800088
Product Code: RWJ-800088
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: not assigned
CAS Number: Notavailable
Current Sponsor code: RWJ-800088
Other descriptive name: JNJ-26366821 (j&j code), SF303(UCB Bioproducts code)
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 0-3.5
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous bolus use (Noncurrent)

Primary Outcome(s)

Main Objective: To evaluate the efficacy of RWJ-800088 on the prevention of CIA in subjects with non-small cell lung cancer (NSCLC) receiving a 21-day chemotherapy regimen of gemcitabine and either carboplatin or cisplatin.

Secondary Objective: To evaluate the efficacy of RWJ-800088 on the prevention of CIT in subjects with NSCLC receiving a 21-day chemotherapy regimen of gemcitabine and either carboplatin or cisplatin.

To evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD)
of RWJ-800088 in subjects with NSCLC receiving a 21-day chemotherapy regimen of gemcitabine and either carboplatin or cisplatin.

To evaluate the effect of RWJ-800088 on patient-reported outcome (PRO)
assessments, and to further validate these assessments, in subjects with
NSCLC receiving a 21-day chemotherapy regimen of gemcitabine and either
carboplatin or cisplatin.

Primary end point(s): The incidence rate of the composite endpoint of Grade 2 or higher anemia, or a = 2 g/dL drop in hemoglobin on the first day of any chemotherapy cycle (Cycle 2 to 6) relative to baseline (Cycle 1, Day 1), or the use of rescue intervention for anemia (e.g., erythropoiesis stimulating agents [ESAs], red blood cell [RBC] transfusion).

Secondary ID(s)

800088NAP2001