- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00088023
Safety Study of PT-523 in Cancer Patients to Treat Solid Tumors Including a Preliminary Assessment of Effectiveness
A Phase I Study of PT-523 in Patients With Solid Tumors
Study Overview
Detailed Description
The primary objectives of this study are 1) to evaluate the safety of a short intravenous infusion of PT-523 when administered on days 1, 8, and 15 of a 28-day cycle to patients with solid tumors who have failed curative or survival prolonging therapy or for whom no such therapies exist; and 2) to establish the maximum tolerated dose (MTD) and identify the dose limiting toxicities (DLT) of PT-523.
The secondary objectives of this study are to determine the pharmacokinetics and to evaluate preliminary efficacy of PT-523.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
Boston, Massachusetts, United States, 02215
- Beth Isreal Deaconess Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Presence of metastatic or inoperable malignancy, other than leukemia or a primary central nervous system (CNS) tumor, for which there is no known curative or survival prolonging palliative therapy, or failure of these therapies .
- Age greater than or equal to 18 years.
- Life expectancy greater than or equal to 2 months.
- ECOG performance status 0 - 2.
- Adequate organ function and bone marrow reserve.
- Use of appropriate contraceptive method.
- Sign patient informed consent.
Exclusion Criteria:
- Active brain metastases.
- Presence of third-space fluid collections (pleural effusion, ascites).
- Major surgery within 3 weeks prior to dosing.
- Prior chemotherapy or radiation therapy within 3 weeks prior to dosing (6 weeks for nitrosoureas or mitomycin-C). Prior antifolate therapy is permitted, as long as it has not been administered within 3 weeks prior to dosing with PT-523.
- Prior bone marrow transplantation.
- Presence of uncontrolled serious medical or psychiatric illness.
- Patients requiring radiation therapy.
There are no limitations on the extent or type of prior therapy received by the patient other than the time intervals indicated above, as long as the patient has demonstrated complete recovery from any adverse effects, and fulfills all relevant inclusion criteria.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joseph Paul Eder, M.D., Dana-Farber Cancer Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 02-000
- DFCI Legacy- 03-183
- CTEP Grant No.- UO1-CA62490-09
- NSC No.- 712783
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 Neoplasms
-
GlaxoSmithKlineCompleted
-
Amphia HospitalRecruitingColonic Neoplasms MalignantNetherlands
-
Marquette General Health SystemUpper Michigan Brain Tumor CenterWithdrawnGlioma | MeningiomaUnited States
-
European Association for Endoscopic SurgeryWithdrawn
-
Ann & Robert H Lurie Children's Hospital of ChicagoCompletedBrain Stem Neoplasms, Primary | Neoplasms, Brain StemUnited States
-
Moscow Clinical Scientific CenterRecruitingCecal Neoplasms | Colonic Neoplasms MalignantRussian Federation
-
GlaxoSmithKlineRecruitingNeoplasms, RectalUnited States, France, Italy, Japan, Spain, United Kingdom, Germany, Korea, Republic of, Canada, Netherlands
-
Russian Society of Colorectal SurgeonsRecruitingNeoplasms,ColorectalRussian Federation
-
Third Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
-
Novartis PharmaceuticalsBayerCompletedColorectal Neoplasms | Rectal Neoplasms | Colonic NeoplasmsUnited States, Germany, Belgium, Canada, Spain, United Kingdom, Taiwan, France, Switzerland, Sweden, Portugal, New Zealand, Italy, Slovakia, Australia, Austria, Brazil, Hong Kong
Clinical Trials on PT-523 for Injection
-
Spectrum Pharmaceuticals, IncWithdrawnNon-Small-Cell Lung CarcinomaUnited States, Russian Federation
-
Spectrum Pharmaceuticals, IncWithdrawn
-
Promontory Therapeutics Inc.Active, not recruitingUrogenital Neoplasms | Neoplasms by Site | Genital Neoplasms, Male | Prostatic Neoplasms | Advanced Solid Tumors | mCRPC | Metastatic Castrate-resistant Prostate Cancer | CRPC | PT-112United States, France
-
SciClone PharmaceuticalsUnknown
-
Shin Kong Wu Ho-Su Memorial HospitalCompletedRotator Cuff Tear | Ultrasonography | Rotator Cuff TendinopathyTaiwan
-
Instituto Brasileiro de Controle do CancerRecruitingSurgery | SARS-CoV-2 | OncologyBrazil
-
Bio-Thera SolutionsNot yet recruiting
-
Kinex Medical Company, LLCHealth Factors IncActive, not recruitingOsteoarthritis, KneeUnited States
-
Shanghai Gebaide Biotechnology Co., Ltd.UnknownNon-small-cell Lung Cancer (NSCLC) Stage IVChina
-
Suzhou Suncadia Biopharmaceuticals Co., Ltd.Not yet recruiting