Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Immune System Diseases

Rare Diseases

Lung Neoplasms

Hypersensitivity

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

picoplatin

Hazel Breitz, MD

Paul Weiden, MD

David Karlin, MD

This is a Phase II research study that is designed for patients who have small cell lung cancer (SCLC) that is no longer responding to treatment. Patients will receive picoplatin, a new platinum-based agent that is currently under investigation, in 21-day cycles.

Platinum drugs work by binding to DNA and preventing the rapid cell division of tumors. However, many tumors demonstrate a resistance to platinum drugs. Results from preclinical studies indicate that picoplatin (previously called AMD473 or ZD0473) may be able to overcome or partially overcome platinum resistance. More than 500 patients have received picoplatin in previous Phase I or Phase II clinical trials.

Picoplatin as Second-Line Therapy for Patients With Small Cell Lung Cancer

A Phase II Study of Picoplatin as Second-Line Therapy for Subjects With Resistant or Refractory Small Cell Lung Cancer

Poniard Pharmaceuticals

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks

Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks

ZD4054 Zibotentan

Carboplatin AUC of 5.0 IV on day 1 every 3 weeks

Placebo

Tom Morris

Ian Thomas

The purpose of this study is to compare progression-free survival in patients with advanced ovarian cancer treated with ZD4054 in combination with carboplatin+paclitaxel versus placebo in combination with carboplatin+paclitaxel.

ZD4054 (Zibotentan) or Placebo Plus Chemotherapy in Patients With Advanced Ovarian Cancer

A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of ZD4054 (Zibotentan) Plus Carboplatin and Paclitaxel or Placebo Plus Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy

Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method.

Median time (in months) from randomisation until death using the Kaplan-Meier method.

Objective response rate defined as participants with a complete or partial response according to RECIST

ISTITUTO REGINA ELENA - CENTRO RICERCHE SPERIMENTALI

AstraZeneca

ZD4054+Paclitaxel+Carboplatin

Placebo+Paclitaxel+Carboplatin

Total

Overall

Age Continuous

Sex: Female, Male

Gerard Lynch

Progression Free Survival

Overall Survival was not analysed as the study was terminated early.

Overall Survival

The number of participants for analysis corresponds to patients with measurable disease at study entry

Tumour Response Rate

Overall Study

Symptoms and General Pathology

Recurrence

Gemcitabine

Poly(ADP-ribose) Polymerase Inhibitors

Iniparib

Enzyme Inhibitors

BSI-201 in combination with gemcitabine and carboplatin.

BSI-201

Clinical Sciences & Operations

The purpose of this study is to evaluate the effect of BSI-201 on the objective response rate in platinum-resistant recurrent ovarian cancer patients receiving gemcitabine and carboplatin.

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Resistant Recurrent Ovarian Cancer

A Phase 2, Multi-Center, Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Resistant Recurrent Ovarian Cancer

Sanofi

The purpose of this study is to evaluate the effect of BSI-201 on the objective response rate in platinum-sensitive recurrent ovarian cancer patients receiving gemcitabine and carboplatin.

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Sensitive Recurrent Ovarian Cancer

A Phase 2, Multi-Center, Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Sensitive Recurrent Ovarian Cancer

Spots Global Cancer Trial Database for sensitive

Every month we try and update this database with for sensitive cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Picoplatin as Second-Line Therapy for Patients With Small Cell Lung Cancer	NCT00116610	Small Cell Lung...	picoplatin	18 Years -	Poniard Pharmaceuticals
ZD4054 (Zibotentan) or Placebo Plus Chemotherapy in Patients With Advanced Ovarian Cancer	NCT00929162	Patients With A...	ZD4054 Zibotent... Paclitaxel Carboplatin Placebo	18 Years -	AstraZeneca
A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Resistant Recurrent Ovarian Cancer	NCT01033292	Ovarian Cancer	BSI-201	18 Years -	Sanofi
A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Sensitive Recurrent Ovarian Cancer	NCT01033123	Ovarian Cancer	BSI-201	18 Years -	Sanofi
A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Resistant Recurrent Ovarian Cancer	NCT01033292	Ovarian Cancer	BSI-201	18 Years -	Sanofi
A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Sensitive Recurrent Ovarian Cancer	NCT01033123	Ovarian Cancer	BSI-201	18 Years -	Sanofi

Spots Global Cancer Trial Database for sensitive

Every month we try and update this database with for sensitive cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sensitive cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.