A Trial Of SU14813 In Patients With Advanced Solid Malignancies
NCT00982267
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- Patients with a histologically proven advanced solid malignancy for which no recognized therapy was available or for which standard therapy had failed
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Serum albumin ≥3.0 g/dL and adequate haemopoietic, renal and liver function
- Chemotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) or radiotherapy
or an investigational agent within 4 weeks before the start of study treatment
- Subjects had to have recovered from all prior treatment toxicities, except alopecia,
and from any major surgery.
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Descriptive Information | ||||
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Brief Title ICMJE | A Trial Of SU14813 In Patients With Advanced Solid Malignancies | |||
Official Title ICMJE | A Phase I Dose Escalating Study Of SU014813 In Patients With Solid Tumors Not Amenable To Conventional Therapy | |||
Brief Summary | The purpose of this study is to define the Maximum tolerated dose of SU14813 when administered as single agent in patients with solid tumors. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE | Drug: SU014813
Escalating doses of SU014813 from 50 to 250mg/day . Capsules administered daily either as continuous dosing or in cycles of 4 weeks on 1 week off | |||
Study Arms ICMJE | Experimental: SU014813
Intervention: Drug: SU014813 | |||
Publications * | Fiedler W, Giaccone G, Lasch P, van der Horst I, Brega N, Courtney R, Abbattista A, Shalinsky DR, Bokemeyer C, Boven E. Phase I trial of SU14813 in patients with advanced solid malignancies. Ann Oncol. 2011 Jan;22(1):195-201. doi: 10.1093/annonc/mdq313. Epub 2010 Jul 6. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 77 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | June 2011 | |||
Actual Primary Completion Date | November 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Germany, Netherlands | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00982267 | |||
Other Study ID Numbers ICMJE | RTKD-7840-002 A6191002 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | August 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |