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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over Pharmaceutical / Industry 0601 NCT00465491

Trial Description

Summary

Picoplatin is a new type of platinum drug that has been investigated in several clinical trials, and may provide an improved safety profile over current treatment options. This study is designed to compare the efficacy and safety of picoplatin plus Best Supportive Care (BSC) with BSC alone. Best Supportive Care includes care and treatment to optimize the comfort of patients and their ability to function, as well as to minimize the side-effects of anti-cancer treatments.

Further Study Information

This Phase 3 study will enroll subjects with Small Cell Lung Cancer (SCLC) who are refractory or progressive within 6 months of completing first-line, platinum-containing chemotherapy. Subjects will be centrally randomized 2:1 to receive picoplatin plus BSC every 3 weeks, or BSC alone. After discontinuation of picoplatin, all subjects will continue to receive BSC and will continue to be evaluated every 3 weeks until discontinuation from the study, death, or the end of the study. After discontinuation of picoplatin, subjects may be treated with another chemotherapy at their physician's discretion and then will be followed for survivial.

Eligibility Criteria

Inclusion Criteria:

• Histological or cytological diagnosis of SCLC or combined SCLC/non-small cell lung cancer (NSCLC) defined as SCLC mixed with squamous cell carcinoma, adenocarcinoma, or large cell carcinoma.

• One and only 1 prior cisplatin or carboplatin-containing chemotherapy regimen for SCLC within the scope of the National Comprehensive Cancer Network (NCCN) Guidelines (Section 5.4.1).

• Radiological evidence of SCLC that never responded or progressed within 90 days after completion of first-line therapy (refractory); or responded initially to first-line therapy but progressed between 91 and 180 days after treatment was completed (progressed within 91 to 180 days).

• CT scans of chest and abdomen (including adrenals and full extent of liver) with contrast, preferably within 14 days prior to randomization (up to 21 days is allowed if necessary). MRI is acceptable in the case of allergy to contrast agents. The presence or absence of measurable disease by RECIST must be documented from the baseline CT or MRI scan.

• Head CT or MRI scan within 14 days prior to randomization (up to 21 days is allowed if necessary) demonstrating absence of brain metastases.

• ECOG PS 0, 1 or 2 within 3 days prior to randomization (Appendix II).

• Life expectancy of at least 8 weeks within 3 days prior to randomization.

• At least 21 days must have elapsed since the most recent prior chemotherapy dose, with evidence of hematological recovery.

• At least 14 days must have elapsed since the most recent prior radiotherapy dose.

• At least 14 days must have elapsed since prior surgery except for the placement of venous access device or bronchoscopy.

• Subject must be recovered to ≤ Grade 1 toxicity from all non-hematological adverse effects of prior therapies (excluding alopecia).

• ANC ≥ 1.5 x 109/L.

• Platelet count ≥ 100 x 109/L.

• Hemoglobin of ≥ 90 g/L (transfusion permitted to achieve this hemoglobin).

• Aspartate aminotransferase, alanine aminotransferase, and lactate dehydrogenase levels ≤ 2.5 times upper limit of normal (ULN) or ≤ 5 times ULN if liver involvement is present.

• Bilirubin of ≤ 1.5 times upper limit of normal (ULN).

• Blood urea nitrogen ≤ 1.5 times ULN (hypovolemic subjects may be hydrated to achieve this BUN).

• Creatinine clearance of ≥ 50 mL/min, as calculated by the Cockcroft-Gault formula (Appendix III).

• Women of childbearing potential must have a negative pregnancy test (serum or urine). Sexually active couples of child-bearing potential must agree to use appropriate birth control methods during chemotherapy and for 3 months after chemotherapy.

• Signed informed consent.

Exclusion Criteria:

• Prior radiotherapy that included ≥ 30% of the bone marrow (Appendix IV).

• Pleural effusion as the only radiological evidence of SCLC.

• Presence or history of brain or central nervous system (CNS) metastases.

• Grade 2 or higher peripheral neuropathy.

• Significant cardiac disease, defined as myocardial infarction within 3 months prior to randomization, congestive heart failure classified by the New York Heart Association as Class III or IV (Appendix V), uncontrolled cardiac arrhythmias, poorly controlled or unstable angina, or electrocardiographic evidence of acute ischemia.

• Serious medical or psychiatric illness that could potentially interfere with the completion of study treatment according to this protocol, e.g., active infection, Crohn's disease, ulcerative colitis, etc.

• Use of other investigational drugs within 30 days prior to randomization.

• Breast-feeding.

• History of any other malignancy within 5 years, with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix.

Trial Contact Information

Trial Lead Organizations/Sponsors

Poniard Pharmaceuticals, Incorporated

Dr. Hazel Breitz, M.D.

Study Director

Barbara Schaeffler, MBA, CCRP		Ph: 1-888-879-7007
		Email: clinicaltrials@poniard.com

Hazel Breitz, MD		Ph: 206-286-2516
		Email: hbreitz@poniard.com

India
	Asarwa
	Gujrat Cancer Research Institute
		Contact Person	Ph: 91 98259 40769
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Shailesh Talati	Principal Investigator
	Bhopal
	Jawaharlal Nehru Cancer Hospital & Research Centre
		Contact Person	Ph: 91 755 2665720
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		T P Sahoo	Principal Investigator
	Chennai
	Apollo Speciality Hospital
		Contact Person	Ph: 044 2432 9044
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		M A Raja	Principal Investigator
	Cochin (Kochi)
	Lakeshore Hospital and Research Center - Cochin
		Dr. Betty George	Ph: +91-934-984-1118
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Dr. V.P. Gangadharan	Principal Investigator
	Hyderabad
	Indo American Institute of Oncology
		Contact Person	Ph: 91 9440591396
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Dattatreya	Principal Investigator
	Jaipur
	SEAROC Cancer Center
		Contact Person	Ph: 91-9828695365
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Ashish Maru	Principal Investigator
	Kolkata
	Institute of Post Graduate Medical Education and Research
		Contact Person	Ph: 91 9833254805
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Prabir Sur	Principal Investigator
	Orchid Nursing Home
		Contact Person	Ph: +91 33 23202729
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		G.S. Bhattacharyya	Principal Investigator
	Lucknow
	King George Medical College
		Contact Person	Ph: 91 522 2255346
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		I D Sharma	Principal Investigator
	Manipal
	KMC (Karturba Medical College) Hospital
		Contact Person	Ph: 98453339525
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Kamalaksh Shenoy	Principal Investigator
	Mumbai
	Jaslok Hospital and Research Centre
		Contact Person	Ph: +91 22 25673333
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Suresh Advani	Principal Investigator
	Tata Memorial Hospital
		Contact Person	Ph: 022 2417 7210
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Hari Menon	Principal Investigator
	Nagpur
	Rashtriya Sant Tukoji Cancer Hospital & Research Centre
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Shete	Principal Investigator
	Nasik
	Shatabdi Superspeciality Hospital
		Contact Person	Ph: 91-253-2365292
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Shailesh Bondarde	Principal Investigator
	New Delhi
	Sir Ganga Ram Hospital
		Contact Person	Ph: 91-98103-93062
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Shyam Aggarwal	Principal Investigator
	Rohini
	Rajiv Gandhi Cancer Institute
		Contact Person	Ph: 91-11-27051011
		Contact Person	Ph: 1-888-878-7007
			Email: clinicaltrials@poniard.com
		D.C. Doval	Principal Investigator
	Tirupati
	Sri Venkateswara Institute of Medical Sciences
		Contact Person	Ph: 91-877-2286803
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		K Sambasivaiah	Principal Investigator
	Trivandrum
	Regional Cancer Center
		Contact Person	Ph: 09895775620
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Jayprakash Madhavan	Principal Investigator
	Vishakhapatnam
	King George Hospital
		Contact Person	Ph: 9393103340
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		P Ravi Mohan	Principal Investigator
Poland
	Grudziadz
	Dr. Bieganski Memorial Regional Specialsitic Hospital
		Contact Person	Ph: +48 56 450 04 75
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Urszula Sadowska	Principal Investigator
	Plock
	Conservative Outpatient Oncology Department, Voyevodship Hospital in Plock
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Anna Fleming	Principal Investigator
	Szczecin
	Specjalistyczny Szpital im. Prof. Alfreda Sokolowskiego
		Contact Person	Ph: +48 91 44 27 209
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Piotr Serwatowski	Principal Investigator
Romania
	Bucharest
	IANULI Medconsult SRL
		Contact Person	Ph: +40 21 31 66 754
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Carmen Ianuli	Principal Investigator
	Cluj-Napoca
	Institutul Oncologic - Universitatea de Medicina
		Contact Person	Ph: +40 264 598 361
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Tudor Ciuleanu	Principal Investigator
	Constanta
	Clinical Emergency County Hospital Constanta
		Contact Person	Ph: +40 241 503 326
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Dana I Ples	Principal Investigator
	Iasi
	Medical Oncology Center Iasi
		Contact Person	Ph: +40 232 216 160
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Constantin Volovat	Principal Investigator
Russia
	Cherepovets
	City Hospital #1
		Contact Person	Ph: 7 8202 571477
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Andrey Gavrilenko	Principal Investigator
	Ekaterinburg
	Sverdlovsk Regional Oncology Center
		Contact Person	Ph: +7-343-376-9988
			Email: clinicaltrials@poniard.com
		Contact Person	Ph: 1-888-879-7007
		Dr. Dmitry Bentsion	Principal Investigator
	Engels
	Regional Oncology Center - Engels
		Contact Person	Ph: 8 (8453) 563781
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Olga Brichkova	Principal Investigator
	Izhevsk
	Republican Clinical Oncology Dispensary - Izhevsk
		Contact Person	Ph: +7 3412 21 97 70
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Sergey Emelyanov	Principal Investigator
	Kazan
	Clinical Oncology Center
		Contact Person	Ph: 7 8435 192600
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Rustem Khasanov	Principal Investigator
	Kazan Oncology Center
		Contact Person	Ph: 7 8432 92 07 41
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Sufia Safina	Principal Investigator
	Krasnodar
	Regional Clinical Hospital No. 1
		Contact Person	Ph: 8 (8612) 52 54 69
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Igor Polyakov	Principal Investigator
	Novosibirsk
	City Clinical Hospital #1
		Contact Person	Ph: 7 383 226 69 90
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Alexander Vitsin	Principal Investigator
	Orenburg
	Orenburg Regional Clinical Oncology Center
		Contact Person	Ph: +7 3532 33 21 92
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Dmitry Kirsanov	Principal Investigator
	Perm
	Perm Regional Oncology Center
		Contact Person	Ph: +7 342 228 00 96
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Andrey Khorinko	Principal Investigator
	Petrozavodsk
	Republican Oncology Center of the Ministry of Healthcare of Karelia Republic
		Contact Person	Ph: 7 8142 764498
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Olga Lazarevich	Principal Investigator
	Pyatigorsk
	Pyatigorsk Oncology Center
		Contact Person	Ph: +7 8793 39 49 02
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Vladimir Vladimirov	Principal Investigator
	St. Petersburg
	City Clinical Oncology Center, Thoracic Oncology Department #6
		Contact Person	Ph: +7-812-756-9923
			Email: clinicaltrials@poniard.com
		Contact Person	Ph: 1-888-879-7007
		Dr. Nina Karaseva, MD, PhD	Principal Investigator
	Pavlov State Medical University
		Contact Person	Ph: +7 812 346 0429
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Sergey Orlov	Principal Investigator
	Syktvkar
	Komi Republican Oncology Center
		Contact Person	Ph: 7 8212 236591
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Elena Matyushina	Principal Investigator
	Tambov
	Tambov Regional Oncology Center
		Contact Person	Ph: +7 4752 72 53 51
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Vladimir Milovanov	Principal Investigator
	Vladivostok
	Primorsky Regional Oncology Center
		Contact Person	Ph: +7 4232 326311
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Ludmila Gurina	Principal Investigator
	Voronezh
	Voronezh State Medical Academy
		Contact Person	Ph: +7 4732 53 32 77
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Vadim Popov	Principal Investigator
Ukraine
	Luzk
	Volyn Regional Oncology Dispensary
		Contact Person	Ph: +38033 22 60 769
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Orest Andrusenko	Principal Investigator
	Mariupol
	Public Treatment and Prevention Institution Mariupol City Interdistrict Oncology Center
		Contact Person	Ph: 38 0629 395355
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Gennady Psaras	Principal Investigator
	Zaporozhye
	Zaporozhye Regional Oncology Center
		Contact Person	Ph: 38 0612 963496
		Contact Person	Ph: 1-888-879-7007
			Email: clinicaltrials@poniard.com
		Anatoly Shevchenko	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00465491
Information obtained from ClinicalTrials.gov on May 27, 2008