A Study of HGS1036 in Combination With Chemotherapy in Subjects With Advanced Solid Malignancies
Trial ID or NCT#
NCT01604863
Status
NOT RECRUITING
Purpose
The primary purpose of this study is to determine the maximally tolerated dose (MTD) of HGS1036 when used in combination with the standard chemotherapeutic regimens paclitaxel plus carboplatin, cisplatin plus etoposide, or docetaxel.
Official Title
Multi-Center, Open-Label Phase 1B Study to Evaluate the Safety and Tolerability of HGS1036 in Combination With Paclitaxel and Carboplatin, Cisplatin and Etoposide, or Docetaxel in Subjects With Advanced Solid Malignancies
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - Have a histological or cytological diagnosis of malignant solid neoplasm requiring systemic chemotherapy. - Age ≥18 years. - ECOG performance status 0-1. - Adequate organ function. - Adequate hematological function. - Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study protocol procedures. - Consent to collection of previously obtained, archival biopsy or surgical specimens of the currently treated malignancy when available.
Exclusion Criteria:
- - Significant cardiac disease. - Eye trauma or disease. - Ocular surgery or blunt force trauma to the eye requiring treatment within 3 months prior to first dose of HGS1036. - Presence or history of ≥ Grade 2 hemoptysis within 2 weeks of the first dose of HGS1036. - Major surgery within 4 weeks of the first dose of HGS1036. - Prior organ or allogeneic stem cell transplant. - Non-healing or chronic wounds. - Receipt of any anti-cancer therapy within 4 weeks prior to first dose of HGS1036. - Receipt of any biological therapy (such as monoclonal antibodies) within 6 weeks of the first dose of HGS1036. - Active CNS involvement by primary or metastatic tumor. - Documented active infection requiring the use of systemic antibiotics. - Pregnancy or lactation. - Known HIV-positive serology, AIDS, or an AIDS-related illness. - Conditions likely to increase the potential for abdominal perforation or fistula formation.
Investigator(s)
Nelson Teng
George A. Fisher Jr.
Medical oncologist,
Gastrointestinal specialist
Colleen Haas Chair in the School of Medicine
Joel Neal, MD, PhD
Medical oncologist,
Thoracic specialist
Associate Professor of Medicine (Oncology)
Contact us to find out if this trial is right for you.
Contact
Jennifer Vargas
650-723-0371
View on ClinicalTrials.gov