- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00516438
Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Topotecan
December 7, 2010 updated by: AstraZeneca
A Phase I, Open-Label, Study of the Safety and Tolerability of KU-0059436 and Topotecan in the Treatment of Patients With Advanced Solid Tumours
The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with topotecan chemotherapy in patients with advanced solid tumours
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Glasgow, United Kingdom
- Research Site
-
Leicester, United Kingdom
- Research Site
-
Manchester, United Kingdom
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histological or cytological diagnosis of advanced solid tumour for which no suitable effective therapy exists;
- Evaluable disease
- Adequate bone marrow, hepatic and renal function
Exclusion Criteria:
- Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry; major surgery with 4 weeks of entering the study
- Heavily pre treated patient > 2 previous chemotherapy regimens for metastatic disease
- Co-existing active infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Topotecan + KU-0059436
|
oral
Other Names:
intravenous infusion
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with topotecan
Time Frame: assessed at each visit
|
assessed at each visit
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To identify the dose limiting toxicity of the combination therapy
Time Frame: assessed at each visit
|
assessed at each visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: James Cassidy, Beaston Oncology Centre, Glasgow, UK
- Study Director: James Carmichael, BSc MBChB MD FRCP, KuDOS Pharmaceutical Ltd
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
August 13, 2007
First Submitted That Met QC Criteria
August 13, 2007
First Posted (Estimate)
August 15, 2007
Study Record Updates
Last Update Posted (Estimate)
December 8, 2010
Last Update Submitted That Met QC Criteria
December 7, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KU36-93
- D0810C00006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Malignant Solid Tumors
-
National Cancer Institute (NCI)RecruitingSolid Tumor | Refractory Solid Tumors | Malignant Solid Tumors | Other Neoplasms Solid Tumors | Pediatric Solid TumorUnited States
-
Memorial Sloan Kettering Cancer CenterRecruitingMalignant Solid TumorsUnited States
-
Chinese PLA General HospitalSinotau Pharmaceutical GroupCompletedMalignant Solid TumorsChina
-
SanofiCompletedMalignant Solid TumorsFrance, Spain, United States, Italy
-
BayerRecruitingSolid Malignant TumorsJapan, Korea, Republic of, France, India, Spain, Taiwan
-
GeneScience Pharmaceuticals Co., Ltd.RecruitingMalignant Solid TumorsChina
-
The First Affiliated Hospital of Guangzhou Medical...Sinotau Pharmaceutical GroupCompletedMalignant Solid TumorsChina
-
AnewPharmaCompletedAdvanced Malignant Solid TumorsChina
-
Tianjin Medical University Cancer Institute and...UnknownMalignant Solid TumorsChina
-
Cancer Institute and Hospital, Chinese Academy...Not yet recruiting
Clinical Trials on KU-0059436 (AZD2281)(PARP inhibitor)
-
AstraZenecaCompletedOvarian Neoplasms | BRCA1 Protein | BRCA2 ProteinNetherlands, Belgium, United Kingdom, Poland
-
AstraZenecaKuDOS Pharmaceuticals LimitedCompletedOvarian NeoplasmUnited States, Spain, Australia, Germany, Sweden
-
AstraZenecaCompleted
-
University of WashingtonNational Cancer Institute (NCI); AstraZenecaTerminatedStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Prostate Adenocarcinoma Without Neuroendocrine DifferentiationUnited States
-
National Cancer Institute (NCI)Active, not recruitingMalignant Glioma | Recurrent Childhood Ependymoma | Rhabdoid Tumor | Advanced Malignant Solid Neoplasm | Refractory Malignant Solid Neoplasm | Recurrent Hepatoblastoma | Recurrent Langerhans Cell Histiocytosis | Recurrent Malignant Solid Neoplasm | Recurrent Medulloblastoma | Recurrent Neuroblastoma | Recurrent... and other conditionsUnited States, Puerto Rico
-
University of WashingtonAstraZenecaTerminatedCastration-Resistant Prostate Carcinoma | Prostate AdenocarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingBRCA1 Gene Mutation | BRCA2 Gene Mutation | Primary Peritoneal High Grade Serous Adenocarcinoma | Stage III Fallopian Tube Cancer AJCC v8 | Stage III Ovarian Cancer AJCC v8 | Stage III Primary Peritoneal Cancer AJCC v8 | Stage IIIA Fallopian Tube Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedUnresectable Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Recurrent Breast Carcinoma | Metastatic Triple-Negative Breast Carcinoma | Platinum-Resistant Fallopian Tube Carcinoma | Platinum-Resistant Primary Peritoneal Carcinoma | Platinum-Resistant Ovarian Carcinoma | Recurrent... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); AstraZenecaCompletedPancreatic Ductal Adenocarcinoma | Metastatic Pancreatic Adenocarcinoma | Stage IV Pancreatic Cancer AJCC v6 and v7United States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingAnatomic Stage III Breast Cancer AJCC v8 | Anatomic Stage IIIA Breast Cancer AJCC v8 | Anatomic Stage IIIB Breast Cancer AJCC v8 | Anatomic Stage IIIC Breast Cancer AJCC v8 | Prognostic Stage III Breast Cancer AJCC v8 | Prognostic Stage IIIA Breast Cancer AJCC v8 | Prognostic Stage IIIB Breast... and other conditionsUnited States