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

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ClinicalTrials.gov Identifier: NCT01604863
Recruitment Status : Suspended (Study suspended prior to enrollment)
First Posted : May 24, 2012
Last Update Posted : November 1, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline ( 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.

Condition or disease Intervention/treatment Phase
Cancer Drug: HGS1036 + Paclitaxel + Carboplatin Drug: HGS1036 + Cisplatin + Etoposide Drug: HGS1036 + Docetaxel Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2012
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : July 2014


Arm Intervention/treatment
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.




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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Human Genome Sciences Inc., a GSK Company
ClinicalTrials.gov Identifier: NCT01604863     History of Changes
Other Study ID Numbers: HGS1036-C1118
First Posted: May 24, 2012    Key Record Dates
Last Update Posted: November 1, 2012
Last Verified: October 2012

Keywords provided by GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ):
Solid Tumors
Cancer
Lung Cancer
Prostate Cancer
Mesothelioma
Small Cell lung Cancer

Additional relevant MeSH terms:
Paclitaxel
Etoposide
Docetaxel
Etoposide phosphate
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Immunoglobulin G
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Immunologic Factors
Physiological Effects of Drugs