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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

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


This study will consist of 3 regimens each containing 2 dose levels of HGS1036 and full dose
chemotherapy. Patients will be treated in sequence with HGS1036 at planned dose levels of 10
mg/kg and 20 mg/kg. Patients who demonstrate stable disease or better may continue to
receive HGS1036 until progressive disease, unacceptable toxicity, patient requests
discontinuation of study treatment, or the Investigator feels further treatment is not in
the patient's best interest. After discontinuation of HGS1036, subjects will be followed for
30 days after the last dose of HGS1036 for safety. The end of study will be defined as 1
year after the last subject begins treatment of HGS1036. Any subject still receiving HGS1036
at this pre-defined end of study, may continue to receive HGS1036, but the only study
assessments required will be for safety.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Time Frame:

Up to 1 year or longer if indicated.

Safety Issue:

Yes

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

HGS1036-C1118

NCT ID:

NCT01604863

Start Date:

June 2012

Completion Date:

July 2014

Related Keywords:

  • Cancer
  • Solid Tumors
  • Cancer
  • Lung Cancer
  • Prostate Cancer
  • Mesothelioma
  • Small Cell lung Cancer

Name

Location

Phoenix, Arizona  85012
Boston, Massachusetts