AFP464 in Treating Patients With Advanced Solid Tumors
Stopped early · Phase 1
Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific
In brief
This phase I trial is studying the side effects and best dose of AFP464 in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as AFP464, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Key facts
- Study ID
- NCT00369200
- Run by
- National Cancer Institute (NCI)
- People needed
- 60
- Starts
- 2006-06-01
- Last updated by the study team
- 2013-12-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Bilirubin normal
- Platelet count >= 100,000/mm³
- AST and ALT =< 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance >= 60 mL/min
- Adequate pulmonary function
- DLCO =< grade 1
- No symptomatic pulmonary disease
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Negative pregnancy test
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to AFP464
- No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situation that would limit study compliance
- No smoking within the past 30 days; must be willing and able to completely refrain from smoking during study participation
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin C, or bleomycin) and recovered
- At least 4 weeks since prior radiotherapy; no prior thoracic radiotherapy; no prior radiotherapy to >= 50% of total marrow volume
- More than 4 weeks since prior experimental therapy (non-FDA-approved agents), immunotherapy, or targeted agents and recovered
- More than 8 weeks since prior UCN-01
- More than 2 weeks since prior hormonal therapy except for patients on androgen suppression for prostate cancer
- Concurrent androgen suppression allowed in patients with prostate cancer
- No concurrent combination antiretroviral therapy for HIV-positive patients
Where it is running
- Wayne State University — Detroit, Michigan, United States
Full record on ClinicalTrials.gov
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