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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01604863
• Other study ID #: HGS1036-C1118
• Status: Suspended
• Phase: Phase 1
• First received: January 23, 2012
• Last updated: October 29, 2012
• Start date: June 2012
• Est. completion date: July 2014

Study information

• Verified date: October 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 54
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• HGS1036 + Paclitaxel + Carboplatin
HGS1036 10 or 20 mg/kg, IV once weekly in each 21-day cycle. Paclitaxel 175 mg/m2 or 200 mg/m2, IV and carboplatin AUC 6.0 mg·min/mL, IV every 3 weeks on Day 1 of each 21-day cycle.
• HGS1036 + Cisplatin + Etoposide
HGS1036 10 or 20 mg/kg, IV once weekly in each 21-day cycle and cisplatin 60-80 mg/m2, IV on Day 1 and etoposide 100-120 mg/m2, IV on Days 1, 2, and 3 of each 21 day cycle.
• HGS1036 + Docetaxel
HGS1036 10 or 20 mg/kg, IV once weekly in each 21-day cycle and docetaxel 75 mg/m2, IV on Day 1 of each 21-day cycle.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Human Genome Sciences Inc., a GSK Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD)		Up to 1 year or longer if indicated.	Yes
Primary	Number of participants with adverse events		Up to 1 year or longer if indicated.	Yes