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| Sponsor: | Abbott |
|---|---|
| Collaborator: |
Genentech |
| Information provided by (Responsible Party): | Abbott |
| ClinicalTrials.gov Identifier: | NCT00878449 |
Purpose
This is a Phase 1 Study Evaluating the Safety of ABT-263 in Combination with Etoposide/Cisplatin in Subjects with Small Cell Lung Cancer (SCLC).
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumors |
Drug: ABT-263 Drug: etoposide/cisplatin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Study Evaluating the Safety of ABT-263 in Combination With Etoposide/Cisplatin in Subjects With Cancer |
| Enrollment: | 12 |
| Study Start Date: | October 2009 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ABT-263 + etoposide/cisplatin |
Drug: ABT-263
150mg of ABT-263 is taken daily for 3 out of 21 days. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.
Other Name: ABT-263
Drug: etoposide/cisplatin
etoposide = 100 mg/m2 Days 1-3 of each Cycle; Max duration 6 cycles. cisplatin = 75 mg/m2 Day 1 of each Cycle; Max duration 6 cycles
Other Name: etoposide, cisplatin
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Must have adequate renal and hepatic function, per local laboratory reference range at Screening as follows:
Exclusion Criteria
Contacts and Locations| United States, Illinois | |
| Site Reference ID/Investigator# 13323 | |
| Chicago, Illinois, United States, 60637 | |
| Site Reference ID/Investigator# 12841 | |
| Maywood, Illinois, United States, 60153 | |
| United States, Maryland | |
| Site Reference ID/Investigator# 12303 | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Massachusetts | |
| Site Reference ID/Investigator# 12305 | |
| Boston, Massachusetts, United States, 02215 | |
| Site Reference ID/Investigator# 20381 | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| Site Reference ID/Investigator# 43505 | |
| Detroit, Michigan, United States, 48202 | |
| United States, New Jersey | |
| Site Reference ID/Investigator# 13322 | |
| New Brunswick, New Jersey, United States, 08901 | |
| Study Director: | Mack Mabry, MD | Abbott |
More Information
| Responsible Party: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00878449 History of Changes |
| Other Study ID Numbers: | M10-234 |
| Study First Received: | April 7, 2009 |
| Last Updated: | September 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Etoposide phosphate Cisplatin Etoposide Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic |