A Study of HGS1036 in Combination With Chemotherapy in Subjects With Advanced Solid Malignancies

• Status: Suspended
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Human Genome Sciences Inc., a GSK Company
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Docetaxel; Etoposide; Etoposide phosphate; Immunoglobulin G; Paclitaxel

Criteria

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.