Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
OSI Pharmaceuticals |
---|---|
Information provided by: | OSI Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00889382 |
This is a multi-center, randomized, open-label, phase I/II study of continuous weekly paclitaxel and escalating doses of intermittent or continuous OSI-906 in patients with recurrent/relapsed ovarian and other solid tumors.
Condition | Intervention | Phase |
---|---|---|
Solid Tumors Ovarian Cancer |
Drug: OSI-906 and Paclitaxel |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study Evaluating Intermittent and Continuous OSI-906 and Weekly Paclitaxel in Patients With Recurrent Epithelial Ovarian Cancer (and Other Solid Tumors) |
Estimated Enrollment: | 169 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Phase 2: Arm A - Intermittent OSI-906 QD + weekly paclitaxel
|
Drug: OSI-906 and Paclitaxel
Intermittent OSI-906 in combination + weekly paclitaxel
|
2: Experimental
Phase 2: Arm B - Continuous OSI-906 BID + weekly paclitaxel
|
Drug: OSI-906 and Paclitaxel
OSI-906 in combination + weekly paclitaxel
|
3: Experimental
Phase 2: Arm C - Weekly Paclitaxel
|
Drug: OSI-906 and Paclitaxel
OSI-906 in combination + weekly paclitaxel
|
The phase 1 dose escalation portion will establish the maximum tolerated dose (MTD) in patients with advanced solid tumors. Once the recommended phase 2 dose (RP2D) is established for both schedules, the phase 2 study will begin. Patients with relapsed/recurrent epithelial ovarian cancer will be randomized 1:1:1 to 3 treatment groups.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: OSIP Medical Information | 800.572.1932 | medical-information@osip.com |
United States, Maryland | |
Johns Hopkins Kimmel Cancer Center | |
Baltimore, Maryland, United States, 21231 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
Canada, Ontario | |
Hamilton Regional Cancer Center | |
Hamilton, Ontario, Canada, L8V 5C2 | |
Switzerland | |
IOSI | |
Bellinzona, Switzerland | |
United Kingdom | |
University Hospital | |
Coventry, United Kingdom, CV2 2DX | |
United Kingdom, Surrey | |
Drug Development Unit Royal Mardsen NHS Foundation Trust | |
Sutton, Surrey, United Kingdom, SM2 5PT |
Study Director: | David Sternberg, MD, PhD | OSI Pharmaceuticals |
Responsible Party: | OSI Pharmaceuticals ( Karsten Witt, MD, VP Clinical Development ) |
Study ID Numbers: | OSI-906-202 |
Study First Received: | April 6, 2009 |
Last Updated: | April 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00889382 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Ovarian Cancer Paclitaxel OSI-906 IGF-1R Solid Tumors |
Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Antimitotic Agents Ovarian Diseases Ovarian Epithelial Cancer |
Recurrence Genital Diseases, Female Paclitaxel Tubulin Modulators Ovarian Cancer Endocrinopathy Antineoplastic Agents, Phytogenic Endocrine Gland Neoplasms |
Ovarian Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Mitosis Modulators Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Antimitotic Agents Ovarian Diseases |
Pharmacologic Actions Adnexal Diseases Genital Diseases, Female Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic Endocrine Gland Neoplasms |