|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Schering-Plough |
|---|---|
| Information provided by (Responsible Party): | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00779584 |
Purpose
This first study in humans of SCH 900776 will evaluate its safety and tolerability when given as monotherapy or in combination with gemcitabine to participants with advanced solid tumors or lymphoma. Participants will be enrolled in cohorts that will receive sequentially higher doses of SCH 900776 in combination with standard doses of gemcitabine The recommended combination doses for a Phase 2 trial (combination-RP2D) will be determined based on safety and biological activity. Up to 10 to 15 additional participants may be studied at the combination-RP2D.
| Condition | Intervention | Phase |
|---|---|---|
|
Hodgkin Disease Lymphoma, Non-Hodgkin Neoplasms |
Drug: SCH 900776 Drug: Gemcitabine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Dose-Escalation Study of SCH 900776 as Monotherapy and in Combination With Gemcitabine in Subjects With Advanced Solid Tumors or Lymphoma |
| Enrollment: | 45 |
| Study Start Date: | October 2008 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: SCH 900776 as monotherapy and in combination with gemcitabine |
Drug: SCH 900776
SCH 900776 will be administered to sequential escalating dose cohorts as an intravenous infusion over at least 30 minutes. Doses of SCH 900776 will either be doubled or increased by 40%, depending on the toxicities observed and the specific dose level, and by 20% increments above 200 mg. SCH 900776 will be given as monotherapy on Cycle 0 Day 1 for participants in the dose escalation portion, and starting with Cycle 1 in combination with gemcitabine on Days 1 and 8 of a 21 day treatment cycle for all participants
Drug: Gemcitabine
Depending on the part of the dose escalation portion of the trial, the participant will receive 800 mg/m2, 1000 mg/m2 or based upon safety, 1250 mg/m2. Starting with Cycle 1, gemcitabine will be administered intravenously over at least 30 minutes on Days 1 and 8 of a 21-day treatment cycle.
Other Name: Gemzar
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00779584 History of Changes |
| Other Study ID Numbers: | P05248 |
| Study First Received: | October 22, 2008 |
| Last Updated: | August 18, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Neoplasms Hodgkin Disease Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Gemcitabine Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |