| CTRI Number |
CTRI/2010/091/001403 [Registered on: 04/01/2011] |
| Last Modified On: |
27/07/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Bavituximab Plus Docetaxel in patients with Previously Treated Locally Advanced or Metastatic Non-Squamous Non Small Cell Lung Cancer. |
Scientific Title of Study
Modification(s)
|
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Bavituximab Plus Docetaxel in patients with Previously Treated Locally Advanced or Metastatic Non-Squamous Non Small Cell Lung Cancer. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| PPHM 0902 |
Protocol Number |
| NCT01138163 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Robert Fernandez |
| Designation |
Sr.Manager |
| Affiliation |
PRA International |
| Address |
Sr. Manager, Clinical Operations, PRA International- India
B 402, Business Square, Andheri Kurla Road, Chakala
Mumbai
MAHARASHTRA
400 093
India |
| Phone |
91-22-66171015 |
| Fax |
91-22-66171001 |
| Email |
FernandezRobert@PRAIntl.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Robert Fernandez |
| Designation |
Sr. Manager |
| Affiliation |
PRA International |
| Address |
Sr. Manager, Clinical Operations, PRA International- India
B 402, Business Square, Andheri Kurla Road, Chakala
Mumbai
MAHARASHTRA
400 093
India |
| Phone |
91-22-66171015 |
| Fax |
91-22-66171001 |
| Email |
FernandezRobert@PRAIntl.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Robert Fernandez |
| Designation |
Sr. Manager |
| Affiliation |
PRA International |
| Address |
Sr. Manager, Clinical Operations, PRA International- India
B 402, Business Square, Andheri Kurla Road, Chakala
Mumbai
MAHARASHTRA
400 093
India |
| Phone |
91-22-66171015 |
| Fax |
91-22-66171001 |
| Email |
FernandezRobert@PRAIntl.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Peregrine Pharmaceuticals, Inc
1472 Franklin Avenue- Suite 100 Tustin- CA 92780 USA |
|
Primary Sponsor
Modification(s)
|
| Name |
Peregrine Pharmaceuticals Inc Franklin Avenue Suite Tustin CA USA |
| Address |
1472 Franklin Avenue- Suite 100 Tustin- CA 92780 USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
Ukraine |
Sites of Study
Modification(s)
|
| No of Sites = 15 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sadashivadu Gundeti |
Nizams Institute of Medical Sciences |
Professor of Medical Oncology,,Room 607, 6th Floor, E Block, Panjagutta. -500082
Hyderabad
ANDHRA PRADESH |
91-9246571537
91-40-23371747
telerama@rediffmail.com |
| Dr. Vinod Raina |
All India Institute of Medical Sciences |
Institute Rotary Cancer Hospital,All India Institute of Medical Sciences. Ansari Nagar-110029
New Delhi
DELHI |
+91-11 26593679
91-1126588408
vinodraina@hotmail.com |
| Dr Shekhar Patil |
Bangalore Institute of Oncology Specialty Centre |
HCG Towers, No. 8, P. Kalinga Rao Road,Sampangi ram Nagar,-560027
Bangalore
KARNATAKA |
91-9341245961
91-80-40206059
spassociates@rediffmail.com |
| Dr MS Vishveshwara |
Bharath Hospital and Institute of Oncology |
HCG- Bharath Hospital & Institute of Oncology, #438, Outer ring road, Hebbal
Mysore
KARNATAKA |
91-821-4280011
91-821-4280284
tpandotra@triesta.com |
| Dr. Suresh Attili |
Bibi General Hospital & Cancer centre |
16-3-991/1/C, Government Printing Press Road, ,Malakpet,-500024
Hyderabad
ANDHRA PRADESH |
91 9246243034
91 40 23398667
sureshattili@yahoo.com |
| Dr. Anand Pathak |
Cancer Care Clinic & Hospital |
5th Floor, Vasant Sheela Tower,,Lokmat Square,-440012
Nagpur
MAHARASHTRA |
91-9823038498
91 7122461565
jueely1194@yahoo.co.in |
| Dr Sudhir Singh |
Chhatrapati Shahuji Maharaj Medical University |
Dept. of Radiotherapy
Chowk
C.S.M Medical University,
U.P, Lucknow 226003
Lucknow
UTTAR PRADESH |
91-749-9737814
91-522-2207651
dr_sudhir78@yahoo.com |
| Dr. Loknath Dasapa |
Kidwai Memorial Institute of Oncology |
Dr.M.H.Marigowda Road,,-560 029
Bangalore
KARNATAKA |
91 9845695589
91 80 26565671
drloku@hotmail.com |
| Dr. Umesh Takalkar |
Kodlikeri Memorial Hospital |
8, Manjeet Nagar, Opp Akashwani,,Jalna Road-431 005
Aurangabad
BIHAR |
91-9822042425
91 240 235 92 79
unmesh_3@sancharnet.in |
| Dr. Jitendra Kumar Singh |
Mahavir Cancer Sansthan |
Mahavir Cancer Sansthan,Phulwarisharif, -801505
Patna
BIHAR |
91-9431021001
91 612 2253957
drjksingh147@hotmail.com |
| Dr. Lovenish Goyal |
O.P.Jindal Institute of Cancer & Research |
Model Town,-125 005
Hisar
HARYANA |
91 9729065479
91 01662 221700
lovegoyal@yahoo.com |
| Dr. minish Jain |
Ruby Hall Clinic |
40 Sassoon Rd,-411001
Pune
MAHARASHTRA |
91-9823133390
91 020 66455605
minishjain009@gmail.com |
| Dr Sameer Khatri |
Shanti Mukund Hospital Curie Cancer Centre |
HCG SMH Curie Centre, # 2, Institutional Area Karkardooma, Vikas Marg Extension, Delhi - 110 092, India
North
DELHI |
91-9810381883
91-11-43006060
drsamkhatri@rediffmail.com |
| Dr. Shailesh Bondarde |
Shatabdi Superspeciality Hospital |
Opp Mahamarg Bus Stop,Mumbai Naka-422 005
Nashik
MAHARASHTRA |
91-9822012427
0253 2502105
shaileshbondarde@yahoo.com |
| Dr. Dharampal Singh |
SMS Medical College & Hospital |
Senior Professor and HOD, Radiotherapy & Oncology Hospital, SMS Medical College & Attached Hospital,,Savai Ram Singh Road-302004
Jaipur
RAJASTHAN |
91 141 2518478
91 141 2518478
drdpsingh@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| Central Ethics Committee for HCG Group of Hospitals |
Approved |
| Central Ethics Committee-Dr. Khatri |
Approved |
| Central India Medical Research Ethics Committee, |
Approved |
| Ethical Review Board |
Approved |
| Ethics Committee |
Approved |
| Ethics Committee |
Approved |
| Ethics Committee SMS Medical College & Hospital |
Approved |
| ETHICS COMMITTEE, |
Approved |
| IEC of the Nizams Institute of Medical Sciences, |
Approved |
| Institute Ethics Committee |
Approved |
| Institutional Ethics Commiittee |
Approved |
| Institutional Ethics Committee |
Approved |
| Medical Ethics Committee Kidwai Memorial |
Approved |
| Shatabdi Hospital Ethics Committee |
Approved |
| Society for the Promotion of Ethiical Clinical Trial - Ethics Review Board, |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Previously Treated Locally Advanced or Metastatic Non-Squamous
Non-Small-Cell Lung Cancer
, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Docetaxel + Palcebo |
75mg/m2+Placebo
Day 1. Docetaxel, 75 mg/m2, will be given on
Day 1 of each 21-day cycle for up to 6 cycles, and placebo or the assigned dose of bavituximab will be given
weekly. |
| Comparator Agent |
NiL |
NiL |
| Intervention |
Placebo |
All patients who complete the Combination Therapy Period (or discontinue for any reason other than disease
progression or toxicity) will be eligible to enter the Monotherapy Period. Patients will continue to receive assigned
blinded treatment (placebo or 1 or 3 mg/kg bavituximab) weekly until progression or toxicity. |
| Intervention |
Placebo+ Bavituximab |
Study visits are scheduled to occur every 7 (± 2) days for blinded treatment (bavituximab or placebo)
administration; docetaxel administration will occur every 21 days (±2 days). |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
1. Written informed consent has been obtained.
2. Adults over age 18 years of age with a life expectancy of at least 3 months.
3. Histologically or cytologically confirmed stage IIIB or stage IV non-squamous NSCLC who have progressed after 1 chemotherapy regimen (excluding docetaxel; paclitaxel is permitted). Prior bevacizumab or targeted therapy is allowed.
4. Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST, Version 1.1) on cross-sectional imaging that is at least 2 cm in longest diameter (1 cm if measured by spiral computed tomography
[CT]).
5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
6. Adequate hematologic function (absolute neutrophil count [ANC] ≥1,500 cells/μL; hemoglobin ≥9 g/dL, platelets ≥ 100,000/μL).
7. Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min).
8. Adequate hepatic function (bilirubin ≤ upper limit of normal [ULN], alanine aminotransferase [ALT] ≤ 1.5 x ULN and/or aspartate minotransferase [AST] ≤ 1.5 x ULN, alkaline phosphatase ≤ 2.5 x ULN). ALT and/or AST and/or alk phos may be ≤ 5 × ULN if due to liver metastases.
9. Prothrombin time (PT) / international normalized ratio (INR) ≤ 1.5 x ULN.
10. Activated partial thromboplastin (aPTT) time ≤ 1.5 × ULN.
11. D-dimer ≤ 3 × ULN.
12. New York Heart Association classification I or II.
13. Female patients must have a negative urine or serum pregnancy test at screening (pregnancy test not required for patients with bilateral oophorectomy and/or hysterectomy or to those patients who are > 1 year postmenopausal).
14. All patients of reproductive potential must agree to use an approved form of contraception (as determined by the investigator).
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria
1. Squamous, small cell, or mixed (eg, small cell and non-small cell) histology.
2. Known history of bleeding diathesis or coagulopathy (eg, von Willebrand disease or hemophilia).
3. Cavitary tumors or tumors invading or abutting large blood vessels.
4. Bleeding
a) Clinically significant bleeding, such as gross hematuria, gastrointestinal bleeding, and hemoptysis within the 12 months before screening.
b) Minor hemoptysis associated with a procedure such as bronchoscopy is not exclusionary if resolved at least 3 months before screening.
5. Any history of thromboembolic events (eg, deep vein thrombosis or pulmonary thromboembolism); central venous catheter-related thrombosis 6 months prior is allowed.
6. Ongoing therapy with oral or parenteral anticoagulants; patients on low-dose anticoagulants to maintain patency of lines is eligible.
7. Concurrent hormone therapy (eg, estrogen contraceptives, hormone replacement, anti-estrogen).
8. Grade 2 or higher peripheral neuropathy (eg, numbness, tingling, and/or pain in distal extremities).
9. Radiotherapy within 2 weeks preceding Study Day 1.
10. Symptomatic or clinically active brain metastases.
11. Major surgery within 4 weeks of Study Day 1.
12. Pregnant or nursing women.
13. Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease).
14. Any history of symptomatic coronary artery disease, cerebrovascular accident, or transient ischemic attack.
15. A history of any condition requiring anti-platelet therapy (eg, phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists), with the exception of general cardiovascular prophylaxis with aspirin ( 325 mg/day).
16. Serious non-healing wound (including wound healing by secondary intention, ulcer, or bone fracture).
17. Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis.
18. Contraindication to intravenous (IV) contrast media.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
On-site computer system |
Blinding/Masking
Modification(s)
|
Participant and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| compare the objective response rate (ORR; complete response [CR] + partial response [PR]) of placebo plus docetaxel versus bavituximab plus docetaxel in patients with previously treated locally advanced or metastatic non-squamous non-small-cell lung cancer (NSCLC). |
Objective Response Rate [ORR] is defined as the proportion of patients with confirmed CR or PR as a best response per the RECIST 1.1 criteria relative to all patients with baseline measurable disease. The ORR is monitored every 8-weeks for the duration the patient is active on study. Tumor assessments are performed at screening, cycle 3, cycle 5 and then every 8 weeks after cycle 5 until the patient discontinues the study.
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
comparing progression free survival (PFS), duration of response (DR), overall survival (OS), safety (type, frequency, severity and relationship of adverse events [AEs] to study drugs; laboratory and coagulation parameters; and human anti-chimeric antibodies [HACA)
|
in each treatment arms, Objective Response Rate [ORR] is defined as the proportion of patients with confirmed CR or PR as a best response per the RECIST 1.1 criteria relative to all patients with baseline measurable disease. The ORR is monitored every 8-weeks for the duration the patient is active on study. Tumor assessments are performed at screening, cycle 3, cycle 5 and then every 8 weeks after cycle 5 until the patient discontinues the study.
|
| comparing progression free survival (PFS) |
in each treatment arms |
| duration of response (DR), overall survival (OS) |
Tumor assessments are performed at screening, cycle 3, cycle 5 and then every 8 weeks after cycle 5 until the patient discontinues the study
|
| safety (type, frequency, severity and relationship of adverse events [AEs] to study drugs |
in each treatment arms |
| laboratory and coagulation parameters |
Laboratory parameters including coagulation tests are obtained at screening and day 1 of treatment cycles 1 through 6. Laboratory samples are immediately shipped to the central laboratory for analysis and the results, including coagulation results, are provided to the sites with 48-72hrs of the result being analyzed.
|
| human anti-chimeric antibodies [HACA] |
HACA samples are collected at screening, Cycle 3 Day 1, Cycle 5 Day 1 and at Study Exit. HACA analysis will be performed at the end of the study and reported with the final clinical study report.
|
| PK Samples |
PK sampling is not being done in India. PK samples are being obtained from patients recruited in USA only.
|
|
Target Sample Size
Modification(s)
|
Total Sample Size="120"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
17/05/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
30/01/2011 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a prospective, randomized, double-blind, placebo-controlled, multicenter, phase 2 study of a combination of bavituximab plus docetaxel in patients with previously treated locally advanced or metastatic non-squamous NSCLC. This study will be conducted in 2 periods: a Combination Therapy Period and a Monotherapy Period. This study will be conducted at 30 sites approx in US and India and up to 120 patients will be enrolled. The primary objective of this study is to compare the objective response rate (ORR; complete response [CR] + partial response [PR]) of placebo plus docetaxel versus bavituximab plus docetaxel in patients with previously treated locally advanced or metastatic non-squamous non-small-cell lung cancer (NSCLC). Secondary objectives include comparing progression free survival (PFS), duration of response (DR), overall survival (OS), safety (type, frequency, severity and relationship of adverse events [AEs] to study drugs; laboratory and coagulation parameters; and human anti-chimeric antibodies [HACA]), and pharmacokinetic (PK) characteristics among the treatment arms. India, we are plan to enroll upto 60 patients and expecting the first patient to be in 30th of Jan 2011. |