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CompletedNCT03023319Updated Jun 14, 2022

Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors

A Phase 1 interventional study of Bosutinib and Pemetrexed in Carcinoma, Non-Small-Cell Lung, Mesothelioma and Bladder Cancer, sponsored by Nagla Abdel Karim. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-14.

Sponsored by Nagla Abdel Karim · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2022, 4 years 4 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung
  • Mesothelioma
  • Bladder Cancer
  • Ovarian Cancer
  • Peritoneal Cancer
  • Thymoma
  • Thymus Cancer
  • Uterine Cervical Cancer
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 6 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

This is the only study on the registry with Nagla Abdel Karim as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Untreated or symptomatic brain metastases.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Bosutinib and Pemetrexed

    Bosutinib and pemetrexed

    Drug: Bosutinib · Drug: Pemetrexed

Interventions

  • DrugBosutinib

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

  • DrugPemetrexed

    500 mg/m2 every 21 days for 4 cycles

06

What researchers measure

Primary outcomes

  1. Dose-limiting toxicity of the combination of bosutinib and pemetrexed

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

    Time frame: 21 days

  2. Maximum tolerated dose of the combination of bosutinib and pemetrexed

    Time frame: completion of dose escalation

Secondary outcomes

  1. Adverse events of the combination of bosutinib and pemetrexed

    Time frame: 16 weeks

  2. Anti-tumor response rate

    Time frame: 6 and 12 weeks

  3. Progression-free survival

    Time frame: 6 and 12 weeks

07

Study locations

1 site
  • Augusta University Georgia Cancer Center
    Augusta, Georgia 30912, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03023319
Lead sponsor
Nagla Abdel Karim
Responsible party
Nagla Abdel Karim (Associate Professor of Medicine, Augusta University) — Sponsor-investigator
First posted
Jan 18, 2017
Start date
Dec 10, 2019
Primary completion
May 10, 2022
Completion
May 10, 2022
Last update
Jun 14, 2022

Study contacts

Nagla Karim, MD
principal investigator · Augusta University Georgia Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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