NCT01604863

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
54

participants targeted

Target at P50-P75 for phase_1 cancer

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

2 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

November 1, 2012

Status Verified

October 1, 2012

Enrollment Period

2 years

First QC Date

January 23, 2012

Last Update Submit

October 29, 2012

Conditions

Cancer

Keywords

Solid TumorsCancerLung CancerProstate CancerMesotheliomaSmall Cell lung Cancer

Outcome Measures

Primary Outcomes (2)

  • 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.

Study Arms (3)

Arm A

EXPERIMENTAL

HGS1036 + Paclitaxel + Carboplatin

Drug: HGS1036 + Paclitaxel + Carboplatin

Arm B

EXPERIMENTAL

HGS1036 + Cisplatin + Etoposide

Drug: HGS1036 + Cisplatin + Etoposide

Arm C

EXPERIMENTAL

HGS1036 + Docetaxel

Drug: HGS1036 + Docetaxel

Interventions

HGS1036 + Paclitaxel + CarboplatinDRUG

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.

Arm A
HGS1036 + Cisplatin + EtoposideDRUG

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.

Arm B
HGS1036 + DocetaxelDRUG

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.

Arm C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Scottsdale, Arizona, 85258, United States

Location

Unknown Facility

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

NeoplasmsLung NeoplasmsProstatic NeoplasmsMesotheliomaSmall Cell Lung Carcinoma

Interventions

PaclitaxelCarboplatinCisplatinEtoposideDocetaxel

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, MesothelialCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination ComplexesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsGlucosidesGlycosidesCarbohydrates

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2012

First Posted

May 24, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

November 1, 2012

Record last verified: 2012-10

Locations

US(2)