NCT01310244

Brief Summary

To define Phase 1/2 Maximum Tolerated Dose Study of Belinostat (PXD-101) in Combination with Paclitaxel plus Carboplatin in Chemotherapy-Naive Patients with Stage IV Non-Small-Cell Lung Cancer (NSCLC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2010

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

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

Study Start

First participant enrolled

December 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 8, 2011

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

January 6, 2020

Status Verified

January 1, 2020

Enrollment Period

4.7 years

First QC Date

February 28, 2011

Last Update Submit

January 2, 2020

Conditions

Stage IV Non-small Cell Lung Cancer

Keywords

Phase 1/2MTDstage IVNSCLCchemo-naiveMixed-cell dose escalationlung cancernon-small-cellphase IBelinostatCarboplatinPaclitaxeladenocarcinomaPXD-101

Outcome Measures

Primary Outcomes (1)

  • To determine the Maximum Tolerated Dose ( MTD) of belinostat in combination with carboplatin and paclitaxel in patient with Stage IV non-small cell lung cancer who has received no prior systemic chemotherapy.

    At study entry each eligible patient will be assigned a specific dose level and dose of IV belinostat in mg/m2, to be administered daily on Days 1 to 5 each 21 day cycle, for up to 6 cycles. Dose escalation within each patient is not allowed during this study. At each dose level cohort of up to 6 patients may be evaluated during Cycle 1 of therapy. Multiple dose levels may be evaluated to determine the Maximum Tolerated Dose (MTD) of IV belinostat, in combination with 6 cycles of IV carboplatin and paclitaxel, for chemo-naïve patients with Stage IV NSCLC.

    24 Months

Secondary Outcomes (4)

  • Safety and Tolerability when IV belinostat is administered in combination with carboplatin and paclitaxel in patients with chemotherapy naïve Stage IV M1a or M1b NSCLC.

    24 Months

  • Efficacy when IV belinostat is administered in combination with carboplatin and paclitaxel in patients with chemotherapy naïve Stage IV M1a or M1b NSCLC

    24 Months

  • Progression-free survival (PFS) when IV belinostat is administered in combination with carboplatin and paclitaxel in patients with chemotherapy naïve Stage IV M1a or M1b NSCLC

    24 Months

  • Objective response rate (ORR) when IV belinostat is administered in combination with carboplatin and paclitaxel in patients with chemotherapy naïve Stage IV M1a or M1b NSCLC.

    24 Months

Study Arms (1)

Single arm, open label

EXPERIMENTAL

At the study entry each patient will receive a dose level assignment which will include a specific dose level and the dose of IV belinostat in mg/m2 to be administered during the study treatment. Belinostat will be infused over 30 minutes once daily on Days 1-5 of each 21-day cycle. On Day 3, the infusion of belinostat must be completed at least 1 hour prior to the start of the paclitaxel infusion. Dose of belinostat will be assigned at study entry. The same dose and level will remain throughout the entire study for each patient and no dose adjustment will be allowed, except due to toxicity.

Drug: Belinostat, Carboplatin, Paclitaxel

Interventions

Belinostat, Carboplatin, PaclitaxelDRUG

Up to 6 cycles of combination therapy of belinostat plus carboplatin (AUC 6) and paclitaxel 200 mg/m2. Initial dose of belinostat will be 1000mg/m2 for MTD dose escalation evaluation.

Also known as: PXD-101
Single arm, open label

Eligibility Criteria

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

You may qualify if:

  • A histologically or cytologically confirmed diagnosis of Stage IV (M1a or M1b) NSCLC. Patients with mixed non-small cell histologies are eligible
  • No prior chemotherapy for the treatment of advanced NSCLC
  • Prior adjuvant therapy for early stage lung cancer is allowed if completed ≥ 12 months prior to enrollment
  • Age \>= 18 years
  • Adequate organ function
  • Any treatment with investigational agent must have completed ≥ 4 weeks prior to enrollment
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Negative pregnancy test for women of childbearing potential.
  • Patients with brain metastases allowed if:
  • Directed local therapy was completed 2 weeks prior to enrollment;
  • There is no evidence of disease progression and;
  • Steroids are not required

You may not qualify if:

  • Patients with mixed tumors of small cell features
  • Known infection with HIV, hepatitis B or hepatitis C
  • Baseline prolongation of QT/QTcF interval or required concomitant medication that may cause Torsade de Pointes
  • Preexisting ≥Grade 2 neuropathy
  • Valproic acid treatment within 2 weeks of study enrollment
  • Systemic steroids, for any indication, stabilized at \>10 mg/day prednisone
  • Known allergy or hypersensitivity to any component of belinostat, paclitaxel or carboplatin
  • Co-existing active infection or any other uncontrolled medical condition likely to interfere with trial procedures
  • Active concurrent malignancy (except basal cell carcinoma or cervical intraepithelial neoplasia, other potentially cured malignancy that has been in remission for five years or prior adjuvant therapy for early stage lung cancer that is completed ≥ 12 months ago)
  • Pregnant or breast-feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Clearview Cancer Institute (CCI)

Huntsville, Alabama, 35805, United States

Location

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

University Cancer Insitute

Boynton Beach, Florida, 33426, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung NeoplasmsAdenocarcinoma

Interventions

belinostatCarboplatinPaclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Brian Matthews, MD

    Clearview Cancer Institute

    PRINCIPAL INVESTIGATOR

  • Sant Chawla, MD

    Sarcoma Oncology Center

    PRINCIPAL INVESTIGATOR

  • Saiama Waqar, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Thomas Neiderman, MD

    University Cancer Insitute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2011

First Posted

March 8, 2011

Study Start

December 1, 2010

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

January 6, 2020

Record last verified: 2020-01

Locations

US(4)