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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03023319
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Nagla Abdel Karim, Augusta University

Tracking Information
First Submitted Date  ICMJE January 13, 2017
First Posted Date  ICMJE January 18, 2017
Last Update Posted Date January 7, 2020
Estimated Study Start Date  ICMJE January 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
  • Dose-limiting toxicity of the combination of bosutinib and pemetrexed [ Time Frame: 21 days ]
    CTCAE Grade 3 or 4 non‐hematologic toxicities other than alopecia, nausea and vomiting.
  • Maximum tolerated dose of the combination of bosutinib and pemetrexed [ Time Frame: completion of dose escalation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
  • Adverse events of the combination of bosutinib and pemetrexed [ Time Frame: 16 weeks ]
  • Anti-tumor response rate [ Time Frame: 6 and 12 weeks ]
  • Progression-free survival [ Time Frame: 6 and 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors
Official Title  ICMJE Phase I Study of the Non-receptor Kinase Inhibitor Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Carcinoma, Non-Small-Cell Lung
  • Mesothelioma
  • Bladder Cancer
  • Ovarian Cancer
  • Peritoneal Cancer
  • Thymoma
  • Thymus Cancer
  • Uterine Cervical Cancer
Intervention  ICMJE
  • Drug: Bosutinib
    100mg daily for 4 cycles (21 days per cycle)
  • Drug: Pemetrexed
    500 mg/m2 every 21 days for 4 cycles
Study Arms  ICMJE Experimental: Bosutinib and Pemetrexed
Bosutinib and pemetrexed
Interventions:
  • Drug: Bosutinib
  • Drug: Pemetrexed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 14, 2019)
36
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2017)
24
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

- Untreated or symptomatic brain metastases.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kelly Jenkins, RN, MSN 706-721-1206 kejenkins@augusta.edu
Contact: Ashlyn Stevenson, RN, BSN 706-721-0660 asstevenson@augusta.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03023319
Other Study ID Numbers  ICMJE EXP-16-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nagla Abdel Karim, Augusta University
Study Sponsor  ICMJE Nagla Abdel Karim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nagla Karim, MD Augusta University Georgia Cancer Center
PRS Account Augusta University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP