Clinical trial NCT01604863: A Study of HGS1036 in Combination With Chemotherapy in Subjects With Advanced Solid Malignancies
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Cancer
Keywords: Solid Tumors
Cancer
Lung Cancer
Prostate Cancer
Mesothelioma
Small Cell lung Cancer
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-05-24
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD)
timeFrame: Up to 1 year or longer if indicated.
measure: Number of participants with adverse events
timeFrame: Up to 1 year or longer if indicated.
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Boston
country: United States
state: Massachusetts
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: