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

Not Recruiting

Trial ID: NCT01604863


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

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Mark Pegram

Susy Yuan-Huey Hung Professor

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

Jonathan S. Berek, MD, MMSc
Jonathan S. Berek, MD, MMSc

Laurie Kraus Lacob Professor

George A. Fisher Jr.
George A. Fisher Jr.

Colleen Haas Chair in the School of Medicine


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

   - 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


drug: HGS1036 + Paclitaxel + Carboplatin

drug: HGS1036 + Cisplatin + Etoposide

drug: HGS1036 + Docetaxel

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jennifer Vargas

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