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Small Cell Lung CancerPhase 3SPEARNCT00465491

Study of Picoplatin Efficacy After Relapse

A Phase 3 study testing picoplatin in people with Small Cell Lung Cancer, run by Poniard Pharmaceuticals at 143 sites in 15 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
picoplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
399 participants
Where
143 sitesin 15 countries
Study dates
Apr 2007to May 2009
Phase
Phase 3
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

  • 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 head, chest and abdomen (including adrenal 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 gy RECIST must be documented from the baseline CT or MRI scan.
  • Patients with brain metastases must have been treated with brain irradiation. Only patients wtih asymptomatic brain metastases are eligible for this study.
  • ECOG PS 0, 1 or 2 within 3 days prior to randomization (Appendix II).
Show all 21Show fewer
  • 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).
  • Age 18 years or over.
  • 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.

Who cannot join

  • Prior radiotherapy that included ≥ 30% of the bone marrow (Appendix IV).
  • Pleural effusion as the only radiological evidence of SCLC.
  • Untreated or symptomatic 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.
Show all 9Show fewer
  • 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 locations and contacts

143 sites in 15 countries.

143 sites in 15 countries

Russia51 sites

  • Arkhangelsk Regional Clinical Oncology Center

    Arkhangelsk, 163045

  • Altai Regional Oncology Center

    Barnaul, 656049

  • Regional Oncology Center

    Birobidzhan, Jewish Republic, 679016

  • Chelyabinsk Regional Oncology Center

    Chelyabinsk, 454087

  • City Hospital #1

    Cherepovets, 162627

  • Chita Regional Oncology Center

    Chita, 672027

  • Regional Oncology Center

    Engel's, 413115

  • Regional Oncology Center

    Irkutsk, 664035

  • Ivanovo Regional Oncology Center

    Ivanovo, 214000

  • Republican Clinical Oncology Center of the Republic of Udmurtia

    Izhevsk, 426009

  • Kaluga Regional Oncology Center

    Kaluga, 248007

  • Clinical Oncology Center

    Kazan', Tatarstan Republic, 420029

  • Kazan Oncology Center

    Kazan', Tatarstan Republic, 420111

  • Regional Clinical Oncology Center

    Khabarovsk, 680042

  • Regional Clinical Oncology Center

    Kirov, 610021

  • City Oncology Center

    Komsomolsk-on-Amur, 681000

  • Krasnodar Clinical Oncology

    Krasnodar, 350040

  • Regional Clinical Hospital #1

    Krasnodar, 350086

  • Kurst Regional Oncology Center

    Kurst

  • Lipetsk Regional Oncology Center

    Lipetsk, 398005

  • Magnitogorsk Clinical Oncology Hospital

    Magnitogorsk, 455001

  • Blokhin Russian Oncology Research Center

    Moscow, 115478

  • Central Clinical Hospital and Outpatient Unit of the Medical Center under the Russian Presidential Administration

    Moscow, 121359

  • Semashko Central Clinical Hospital #2 under Russian Railways

    Moscow, 129128

  • Novorossiysk Oncology Center

    Novorossiysk, 353915

  • City Clinical Hospital #1

    Novosibirsk, 630047

  • Medical Radiology Research Center under RAMS

    Obnninsk, 249036

  • Orenburg Regional Clinical Oncology Center

    Orenburg, 460021

  • Orel Oncology Center

    Oryol, 302020

  • Regional Oncology Center

    Penza, 440071

  • Republican Oncology Center of the Ministry of Healthcare of Karelia Republic

    Petrozavodsk, Karelia Republic, 185007

  • Pyatigorsk Affiliate of Stavropol Regional Clinical Oncology Center

    Pyatigorsk, 357502

  • St. Petersburg City Multifield Hospital #2

    Saint Petersburg, 194354

  • St. Petersburg Pavlov State Medical University

    Saint Petersburg, 197022

  • Pavlov St. Petersburg State Medical University, Pulmonology Research Institute

    Saint Petersburg, 197101

  • City Clinical Oncology Center, Thoracic Oncology Department #6

    Saint Petersburg, 198255

  • Ogarev Mordovian State University

    Saransk, 430032

  • State Higher Education Institution Saratov State Medical University under the Federal Agency for Healthcare and Social Development

    Saratov, 410012

  • Oncology Center

    Sochi, 354057

  • Komi Republican Oncology Center

    Syktyvkar, Komi, 167904

  • Tambov Regional Oncology Center

    Tambov, 390013

  • Tomsk Regional Oncology Center

    Tomsk, 634050

  • Tula Regional Oncology Center

    Tula, 300040

  • Ufa, Republican Oncology Center

    Ufa

  • Buryatia Republican Oncology Center

    Ulan-Ude, Buryatiya Republic, 670047

  • Primorsky Regional Oncology Center

    Vladivostok, 690105

  • Volgograd Regional Clinical Oncology Center#1

    Volograd, 400138

  • Voronezh Regional Clinical Oncology Center

    Voronezh, 394000

  • Regional Clinical Oncology Hospital

    Yaroslavl, 150054

  • Sverdlovsk Regional Oncology Center

    Yekaterinburg, 620036

  • Republican of Clinical Hospital, Mariy-El Republican

    Yoshkar-Ola, 424037

Other trials in Russia

India24 sites

  • Gujrat Cancer Research Institute

    Asarwa, Ahmadabad, 380016

  • Kidwai Memorial Institute of Oncology

    Bangalore, Karnataka, 560029

  • Curie Centre of Oncology

    Bangalore, 560034

  • Jawaharlal Nehru Cancer Hospital and Research Centre

    Bhopal

  • Apollo Speciality Hospital

    Chennai, 600035

  • MNJ Institute of Oncology

    Hyderabaad, 500004

  • Indo American Institute of Oncology

    Hyderabaad, 500034

  • Yashoda Group of Hospitals

    Hyderabad, 500082

  • SEAROC Cancer Center

    Jaipur, 302013

  • Lakeshore Hospital and Research Center

    Kochi, Kerala, 682304

  • Institute of Post Graduate Medical Education and Research

    Kolkata, 700020

  • Orchid Nursing Home

    Kolkata, 700054

  • King George Medical University

    Lucknow

  • KMC (Karturba Medical College) Hospital

    Manipal

  • Jaslok Hospital and Research Centre

    Mumbai, 400026

  • Tata Memorial Centre

    Mumbai

  • Shatabdi Superspeciality Hospital

    Nashik, Maharashtra, 422005

  • Sir Ganga Ram Hospital

    New Delhi, 110060

  • Rajiv Gandhi Cancer Institute, Delhi

    New Delhi, 110085

  • Mahaveer Cancer Sansthan

    Patna, 801505

  • Jahangir Hospital and Research Centre

    Pune, 411001

  • Smt. Vasantben R. Desai Cancer Research Center

    Rajkot, 360007

  • Regional Cancer Centre

    Trivandrum, 695011

  • King George Hospital

    Visakhapatnam

Other trials in India

Poland13 sites

  • Kujawsko-Pomorski Centre of Pulmonology

    Bydgoszcz, 85-326

  • NMP, Memorial Voyvodship Hospital

    Częstochowa, 42200

  • Dr. Bieganski Memorial Regional Specialsitic Hospital

    Grudziądz, 86-300

  • Regional Hospital, Department of Pulmonary Diseases and Chemotherapy

    Krakow, 31202

  • Independent Public Group for Tuberculosis and Lung Disease in Olsztyn

    Olsztyn, 10-357

  • Conservative Outpatient Oncology Department, Voyevodship Hospital in Plock

    Płock, 09-400

  • Department of Clinical Oncology, Wielkopolskie Centre of Lung Diseases and Tuberculosis

    Poznan, 60-569

  • Department of Pulmonology, Voyvodship Specialsitic Hospital in Radom

    Radom, 26-617

  • SP ZOZ Voyevodship Specialistic Hospital #3

    Rybnik, 44-200

  • Department of Chemotherapy, Prof. A. Sokolowski Memorial Specialistic Hospital in Szczecin

    Szczecin, 70-891

  • Department of Clinical Oncology, SP ZOZ, Yoyvodship Specialistic Hospital

    Torun, 87-100

  • Dolnoslaskie Centre of Lung Diseases

    Wroclaw, Lower Silesian Voivodeship, 53-439

  • Silesian Medical University in Katowice

    Zabrze, Dolny Slask, 41-803

Other trials in Poland

Argentina11 sites

  • Consultorios Privados

    Buenos Aires, B1704ESN

  • Clinica Constituyentes

    Buenos Aires, B1708KCH

  • CETEN Centro de Estudio y Tratamiento de Enfermedades Neoplasicas

    Buenos Aires, B1874ACL

  • IADT (Insttituto Argentino de Diagnostico y Tratamiento S.A.)

    Buenos Aires, C1122AAL

  • Centro Oncologico

    Buenos Aires, C1212ACA

  • Instituto Alexander Fleming

    Buenos Aires, C1426ANZ

  • PALIAR

    Buenos Aires, C1430ERF

  • IONC

    Córdoba, X5000AAI

  • Centro Medico San Roque

    San Miguel de Tucumán, T4000IAA

  • Centro Oncologico de Rosario

    Santa Fe, S2000DSK

  • ISIS Clinica Especializada

    Santa Fe, S3002EKI

Other trials in Argentina

Romania11 sites

  • Baia Mare "Constantin Opris" County Emergency Hospital

    Baia Mare, Maramureş, 4800

  • IANULI Medconsult SRL

    Bucharest, 020962

  • Bucharest Institute of Oncology

    Bucharest, 022328

  • Prof. Dr. Ion Chiricuta, Institute of Oncology Cluj-Napoca

    Cluj-Napoca, Cluj, 400015

  • Prof. Dr. Ion Chircuta, Oncology Institute

    Cluj-Napoca, 400015

  • Clinical Emergency County Hospital Constanta

    Constanța, 900591

  • Medical Oncology Center Iasi

    Iași, 700106

  • Schuller Municipal Hospital Ploiesti-Medical Oncology Department

    Ploieşti, 100337

  • Clinical County Hospital

    Sibiu, 550245

  • Sf. loan cel Nou, Emergency County Hospital

    Suceava

  • OncoMed

    Timișoara, 300239

Other trials in Romania

Bulgaria8 sites

  • Multiprofile Hospital for Active Treatment, Dr. Tota Venkova

    Gabrovo, 5300

  • University Multifunctional Hospital for Active Treatment "Dr. Georgi Stranski"

    Pleven, 5800

  • District Dispensary for Cancer Diseases with Inpatient Hospital Plovdiv

    Plovdiv, 4004

  • Regional Oncodispensary with Inpatient Sector

    Rousse, 7000

  • Inter-district Dispensary for Cancer Diseases w/Inpatient Hospital

    Shumen, 9700

  • Regional Oncodispensary with Inpatient Sector-Sofia District

    Sofia, 1233

  • Inter-district Dispensary for Cancer Disease w/Inpatient Hospital "Dr. Marko Markov", Varna

    Varna, 9010

  • Multiprofile Hospital for Active Treatment "St. Marina"

    Varna, 9010

Other trials in Bulgaria

Belarus5 sites

  • Institution of Healthcare "Grodno Regional Clinical Hospital

    Grodno, 230017

  • Gomel Regional Oncological Dispensary

    Homyel, 246012

  • Minsk City Clinical Oncology Dispensary

    Minsk, 220013

  • Research Institute of Oncology and Medical Radiology named by N.N. Aleksandrov

    Minsk, 223040

  • Vitebsk Regional Oncology Dispensary

    Vitebsk, 210603

Other trials in Belarus

Ukraine5 sites

  • Volyn Regional Oncology Center

    Lutsk, 43018

  • Public Treatment and Prevention Institution Mariupol City Interdistrict Oncology Center

    Mariupol, 87500

  • Sumy Regional Oncology Center

    Sumy, 40005

  • Ternopol Regional Clinical Oncology Center

    Ternopil, 46023

  • Zaporozhye Regional Clinical Oncology Center

    Zaporizhzhya, 69040

Other trials in Ukraine

Croatia4 sites

  • Clinical Hospital

    Dubrovnik

  • Clinical Hospital

    Osijek, 31000

  • Clinical Hospital Split

    Split, 2001

  • Clinic for Pulmonary Diseses "Jordanovac"

    Zagreb

Other trials in Croatia

Hungary3 sites

  • St. George County Hospital

    Fejer County, 8000

  • University of Szeged

    Szeged, 6772

  • General Rehablitation and Medicinal Bath Hospital

    Szombathely, 9700

Other trials in Hungary

Bosnia and Herzegovina2 sites

  • Clinic for Lung Diseases, Clinical Center, Banja Luka

    Banja Luka, 78000

  • Clinic of Pulmonary Diseases Podhrastovi

    Sarajevo

Other trials in Bosnia and Herzegovina

Latvia2 sites

  • Daugavas Hospital

    Daugavpils, 5420

  • Paul Stradins Clincial University Hospital

    Riga, 1002

Other trials in Latvia

Serbia2 sites

  • Clinic for Pulmonary Diseases and TBC

    Knez-Selo

  • Institute for Pulmonary Diseases of Vijvodina

    Vijvodina

Other trials in Serbia

Chile1 site

  • Instituto Nacional de Cancer

    Santiago, 2363058

Other trials in Chile

Montenegro1 site

  • Special Hospital for Pulmonary Diseases

    Nikšić, 81400

Other trials in Montenegro

About this study

Official title: A Randomized, Controlled Phase III Trial of Picoplatin and BSC Versus BSC Alone in Patients With Small Cell Lung Cancer (SCLC), Refractory or Progressive Within Six Months of Completing First-Line, Platinum-Containing Chemotherapy.

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.

Read the detailed description

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 survival.

Being tested
picoplatin, best supportive care
Keywords
refractory, chemotherapy, progressed, second-line treatment, small cell lung cancer, best supportive care, picoplatin
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • picoplatinDrug

    IV picoplatin 150mg/m2 q3wk

  • best supportive careOther

    best supportive care

Study groups in NCT00465491
Study groupRoleWhat they receive
1ExperimentalPicoplatin
Receives: Drug: picoplatin
2OtherBSC
Receives: Other: best supportive care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    Measured: death

Secondary outcomes (4)

  1. objective response rate

    Measured: progression

  2. disease control rate

    Measured: progression

  3. duration of response

    Measured: progression

  4. progression-free survival

    Measured: death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionMay 2009 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
399 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00465491
Sponsor's protocol ID
0601
Acronym
SPEAR
Status last verified
Apr 2009
First submitted
23 Apr 2007
Last updated
14 Apr 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Raynaud FI, Boxall FE, Goddard PM, Valenti M, Jones M, Murrer BA, Abrams M, Kelland LR. cis-Amminedichloro(2-methylpyridine) platinum(II) (AMD473), a novel sterically hindered platinum complex: in vivo activity, toxicology, and pharmacokinetics in mice. Clin Cancer Res. 1997 Nov;3(11):2063-74.

    PubMed 9815598

  • Beale P, Judson I, O'Donnell A, Trigo J, Rees C, Raynaud F, Turner A, Simmons L, Etterley L. A Phase I clinical and pharmacological study of cis-diamminedichloro(2-methylpyridine) platinum II (AMD473). Br J Cancer. 2003 Apr 7;88(7):1128-34. doi: 10.1038/sj.bjc.6600854.

    PubMed 12671715

  • Giaccone G, O'Brien ME, Byrne MJ, Bard M, Kaukel E, Smit B. Phase II trial of ZD0473 as second-line therapy in mesothelioma. Eur J Cancer. 2002 Dec;38 Suppl 8:S19-24. doi: 10.1016/s0959-8049(02)80018-1.

    PubMed 12647701

  • Treat J, Schiller J, Quoix E, Mauer A, Edelman M, Modiano M, Bonomi P, Ramlau R, Lemarie E. ZD0473 treatment in lung cancer: an overview of the clinical trial results. Eur J Cancer. 2002 Dec;38 Suppl 8:S13-8. doi: 10.1016/s0959-8049(02)80016-8.

    PubMed 12645908

  • Gore ME, Atkinson RJ, Thomas H, Cure H, Rischin D, Beale P, Bougnoux P, Dirix L, Smit WM. Results of ZD0473 in platinum-pretreated ovarian cancer: analysis according to platinum free interval. Eur J Cancer. 2002 Dec;38 Suppl 8:S7-12. doi: 10.1016/s0959-8049(02)80014-4.

    PubMed 12645907

  • Holford J, Raynaud F, Murrer BA, Grimaldi K, Hartley JA, Abrams M, Kelland LR. Chemical, biochemical and pharmacological activity of the novel sterically hindered platinum co-ordination complex, cis-[amminedichloro(2-methylpyridine)] platinum(II) (AMD473). Anticancer Drug Des. 1998 Jan;13(1):1-18.

    PubMed 9474239

  • Holford J, Sharp SY, Murrer BA, Abrams M, Kelland LR. In vitro circumvention of cisplatin resistance by the novel sterically hindered platinum complex AMD473. Br J Cancer. 1998;77(3):366-73. doi: 10.1038/bjc.1998.59.

    PubMed 9472630

  • Rogers P, Boxall FE, Allott CP, Stephens TC, Kelland LR. Sequence-dependent synergism between the new generation platinum agent ZD0473 and paclitaxel in cisplatin-sensitive and -resistant human ovarian carcinoma cell lines. Eur J Cancer. 2002 Aug;38(12):1653-60. doi: 10.1016/s0959-8049(02)00107-7.

    PubMed 12142057

  • Sharp SY, O'Neill CF, Rogers P, Boxall FE, Kelland LR. Retention of activity by the new generation platinum agent AMD0473 in four human tumour cell lines possessing acquired resistance to oxaliplatin. Eur J Cancer. 2002 Nov;38(17):2309-15. doi: 10.1016/s0959-8049(02)00244-7.

    PubMed 12441268

  • Kawamura-Akiyama Y, Kusaba H, Kanzawa F, Tamura T, Saijo N, Nishio K. Non-cross resistance of ZD0473 in acquired cisplatin-resistant lung cancer cell lines. Lung Cancer. 2002 Oct;38(1):43-50. doi: 10.1016/s0169-5002(02)00175-7.

    PubMed 12367792

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing picoplatin in people with Small Cell Lung Cancer, run by Poniard Pharmaceuticals at 143 sites in 15 countries.

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 21 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 143 sites in Russia, India, Poland, Argentina, Romania and 10 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

overall survival (time frame: death). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00465491, which also lists 10 linked publications.

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 Apr 2009.

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Study of Picoplatin Efficacy After Relapse | AzTrials