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A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing with BB-10901, followed by a Phase II Efficacy Expansion Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing with BB-10901, followed by a Phase II Efficacy Expansion conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing with BB-10901, followed by a Phase II Efficacy Expansion Clinical research trials and A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing with BB-10901, followed by a Phase II Efficacy Expansion medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing with BB-10901, followed by a Phase II Efficacy Expansion. A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing with BB-10901, followed by a Phase II Efficacy Expansion Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing with BB-10901, followed by a Phase II Efficacy Expansion clinical trial. Participants frequently obtain the most expert healthcare available for their A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing with BB-10901, followed by a Phase II Efficacy Expansion condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing with BB-10901, followed by a Phase II Efficacy Expansion  A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing with BB-10901, followed by a Phase II Efficacy Expansion
A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing with BB-10901, followed by a Phase II Efficacy Expansion
For Condition: Small Cell Lung Cancer
Status: Recruiting
Sponsor(s): British Biotech Pharmaceuticals ,
Synopsis: This is a phase I, open-label, dose escalation study to assess the safety, tolerability, PK and efficacy of BB-10901, administered weekly for 4 weeks. Once the MTD has been defined, a phase II efficacy expansion will follow. Based on the predicted PK of BB-10901, this weekly dosing schedule is expected to provide intermittent rather than continuous plasma exposure of the drug conjugate.
Details: The phase II expansion study will be restricted to SCLC patients with relapsed disease and will use a 2-stage design. The dose level to be tested will be the MTD (60 mg/m2). Assuming that at least one response is observed, enrollment will be expanded to a total of 35 patients.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Factorial Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: - Proven SCLC - Relapsed disease; defined as patients with an initial response (partial or complete) to first-line therapy, then relapse more than 3 months after completion of last chemotherapy. - Patients must have received no more than one prior chemotherapy regimen. - Patients must have measurable disease defined as: Lesions that can be measured in at least one dimension according to RECIST - Predicted survival of 3 months or more - Zubrod performance status 0-2 - Patients must not have received chemotherapy or radiation therapy within 4 weeks of study entry, nor have planned surgery. - Other investigational agents must not be taken during the study or within 4 weeks of study entry. - Women of childbearing potential must provide a negative pregnancy test at screening and use adequate contraception in the opinion of the investigator, for the duration of study. - Patients must not have known central nervous system metastases
Total Enrollment: 35
Location and Contact Information:
MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-7095
United States
Recruiting Frank Fossella 713-792-6363
Additional Information:
Study ID Numbers: C10/IVB/001;
Study Start Date: April 2003
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00065429
Other Small Cell Lung Cancer Studies:
1. Chest X-ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer
2. National Lung Screening Trial (NLST)
3. Celecoxib in Preventing Lung Cancer in Former Heavy Smokers
4. A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing with BB-10901, followed by a Phase II Efficacy Expansion
5. Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults
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A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing with BB-10901, followed by a Phase II Efficacy Expansion
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