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Study of Picoplatin Efficacy After Relapse | Clinical Trials | Clareo Health

UNKNOWNPHASE3

Study of Picoplatin Efficacy After Relapse

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.

NCT00465491•Poniard Pharmaceuticals

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 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).
•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.
+11 more criteria

Exclusion Criteria

•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.
•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.

Locations (143)

Consultorios Privados

Buenos Aires, Argentina

Clinica Constituyentes

Buenos Aires, Argentina

CETEN Centro de Estudio y Tratamiento de Enfermedades Neoplasicas

Buenos Aires, Argentina

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

Buenos Aires, Argentina

Centro Oncologico

Buenos Aires, Argentina

Instituto Alexander Fleming

Buenos Aires, Argentina

PALIAR

Buenos Aires, Argentina

IONC

Córdoba, Argentina

Centro Medico San Roque

San Miguel de Tucumán, Argentina

Centro Oncologico de Rosario

Santa Fe, Argentina

Key Dates

Start Date

April 1, 2007

Primary Completion Date

May 1, 2009

Last Updated

April 14, 2009

Enrollment

399

ESTIMATED participants

Conditions

Small Cell Lung Cancer

Interventions

picoplatin

DRUG

best supportive care

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 14, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Picoplatin Efficacy After Relapse

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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