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

Phase 1

Suspended

• Conditions: Cancer
• Interventions: Drug: HGS1036 + Paclitaxel + Carboplatin; Drug: HGS1036 + Cisplatin + Etoposide; Drug: HGS1036 + Docetaxel

• Registration Number: NCT01604863
• Lead Sponsor: Human Genome Sciences Inc., a GSK Company

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-05-22
• Study First Posted: 2012-05-24
• Study Start: 2012-06
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-29
• Last Update Posted: 2012-11-01
• Primary Completion: 2014-06
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	HGS1036 + Paclitaxel + Carboplatin	HGS1036 + Paclitaxel + Carboplatin
Arm B	HGS1036 + Cisplatin + Etoposide	HGS1036 + Cisplatin + Etoposide
Arm C	HGS1036 + Docetaxel	HGS1036 + Docetaxel

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD)	Up to 1 year or longer if indicated.
Number of participants with adverse events	Up to 1 year or longer if indicated.