NCT03023319

Brief Summary

This study will determine the maximum-tolerated dose (MTD) for oral bosutinib when used in combination with pemetrexed. The MTD is the highest dose of bosutinib with pemetrexed that can be given without causing severe side effects. This study will also test the safety of this combination and see what effects (good or bad) it has on participants and their cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

January 13, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
2.9 years until next milestone

Study Start

First participant enrolled

December 10, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2022

Completed
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

2.4 years

First QC Date

January 13, 2017

Last Update Submit

June 10, 2022

Conditions

Carcinoma, Non-Small-Cell LungMesotheliomaBladder CancerOvarian CancerPeritoneal CancerThymomaThymus CancerUterine Cervical Cancer

Outcome Measures

Primary Outcomes (2)

  • Dose-limiting toxicity of the combination of bosutinib and pemetrexed

    CTCAE Grade 3 or 4 non-hematologic toxicities other than alopecia, nausea and vomiting.

    21 days

  • Maximum tolerated dose of the combination of bosutinib and pemetrexed

    completion of dose escalation

Secondary Outcomes (3)

  • Adverse events of the combination of bosutinib and pemetrexed

    16 weeks

  • Anti-tumor response rate

    6 and 12 weeks

  • Progression-free survival

    6 and 12 weeks

Study Arms (1)

Bosutinib and Pemetrexed

EXPERIMENTAL

Bosutinib and pemetrexed

Drug: BosutinibDrug: Pemetrexed

Interventions

BosutinibDRUG

100mg daily for 4 cycles (21 days per cycle)

Bosutinib and Pemetrexed
PemetrexedDRUG

500 mg/m2 every 21 days for 4 cycles

Bosutinib and Pemetrexed

Eligibility Criteria

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

You may qualify if:

  • Pathologically or cytologically proven advanced, metastatic non-squamous non-small cell lung cancer, pleural malignant mesothelioma, bladder or urethral cancer, ovarian cancer, primary peritoneal cancer, thymoma and thymic cancer and uterine cervical cancer.
  • Measurable disease
  • Life expectancy of greater than 3 months.
  • Ability to take folic acid, vitamin B12, and dexamethasone according to protocol.

You may not qualify if:

  • \- Untreated or symptomatic brain metastases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augusta University Georgia Cancer Center

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungMesotheliomaUrinary Bladder NeoplasmsOvarian NeoplasmsThymomaThymus NeoplasmsUterine Cervical Neoplasms

Interventions

bosutinibPemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, MesothelialUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGenital DiseasesEndocrine System DiseasesGonadal DisordersNeoplasms, Complex and MixedLymphatic DiseasesHemic and Lymphatic DiseasesUterine NeoplasmsUterine Cervical DiseasesUterine Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Officials

  • Nagla Karim, MD

    Augusta University Georgia Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

January 13, 2017

First Posted

January 18, 2017

Study Start

December 10, 2019

Primary Completion

May 10, 2022

Study Completion

May 10, 2022

Last Updated

June 14, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)