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

This study has suspended participant recruitment.
(Study suspended prior to enrollment)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT01604863
First received: January 23, 2012
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cancer
 Drug: HGS1036 + Paclitaxel + Carboplatin
Drug: HGS1036 + Cisplatin + Etoposide
Drug: HGS1036 + Docetaxel
 Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: Up to 1 year or longer if indicated. ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events [ Time Frame: Up to 1 year or longer if indicated. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 54
Study Start Date: June 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
HGS1036 + Paclitaxel + Carboplatin
 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.
Experimental: Arm B
HGS1036 + Cisplatin + Etoposide
 Drug: 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.
Experimental: Arm C
HGS1036 + Docetaxel
 Drug: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604863

Locations
United States, Arizona
Scottsdale, Arizona, United States, 85258
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Human Genome Sciences Inc., a GSK Company
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier: NCT01604863     History of Changes
Other Study ID Numbers: HGS1036-C1118
Study First Received: January 23, 2012
Last Updated: October 29, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by GlaxoSmithKline:
Solid Tumors
Cancer
Lung Cancer
 Prostate Cancer
Mesothelioma
Small Cell lung Cancer

Additional relevant MeSH terms:
Etoposide phosphate
Docetaxel
Cisplatin
Etoposide
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013