A Study of HGS1036 in Combination With Chemotherapy in Subjects With Advanced Solid Malignancies
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/23/2012 |
| Start Date: | June 2012 |
| End Date: | July 2014 |
| Contact: | Director Global Medical Information |
| Email: | clinicaltrialsinfo@hgsi.com |
| Phone: | 1-240-314-4430 |
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
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
