Carcinoma, Non-Small-Cell LungPhase 1NCT03023319
Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors
A Phase 1 study testing Bosutinib and Pemetrexed in people with Carcinoma, Non-Small-Cell Lung and Mesothelioma, run by Nagla Abdel Karim at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Mesothelioma, Bladder Cancer
- What is being tested?
- Bosutinib and Pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2019to 10 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Untreated or symptomatic brain metastases.
Trial locations and contacts
1 site in 1 country.
United States1 site
Augusta University Georgia Cancer Center
Augusta, Georgia, 30912
About this study
Official title: Phase I Study of the Non-receptor Kinase Inhibitor Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors
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.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Mesothelioma, Bladder Cancer, Ovarian Cancer, Peritoneal Cancer, Thymoma
- Being tested
- Bosutinib, Pemetrexed
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Mesothelioma, Urinary Bladder Neoplasms, Ovarian Neoplasms, Thymoma, Thymus Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BosutinibDrug
100mg daily for 4 cycles (21 days per cycle)
PemetrexedDrug
500 mg/m2 every 21 days for 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Bosutinib and Pemetrexed | Experimental | Bosutinib and pemetrexed Receives: Drug: Bosutinib; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity of the combination of bosutinib and pemetrexed
CTCAE Grade 3 or 4 non-hematologic toxicities other than alopecia, nausea and vomiting.
Measured: 21 days
Maximum tolerated dose of the combination of bosutinib and pemetrexed
Measured: completion of dose escalation
Secondary outcomes (3)
Adverse events of the combination of bosutinib and pemetrexed
Measured: 16 weeks
Anti-tumor response rate
Measured: 6 and 12 weeks
Progression-free survival
Measured: 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start10 Dec 2019
- Primary completion10 May 2022
- Study completion10 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nagla Abdel Karim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nagla Abdel Karim, Augusta University
- Investigators
- Nagla Karim, MD, Principal investigator, Augusta University Georgia Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023319
- Sponsor's protocol ID
- EXP-16-01
- Status last verified
- Jun 2022
- First submitted
- 13 Jan 2017
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the Non-receptor Kinase Inhibitor Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT03023319
- Acronym / sponsor ID
- EXP-16-01
- Conditions
- Carcinoma, Non-Small-Cell Lung, Mesothelioma, Bladder Cancer, Ovarian Cancer, Peritoneal Cancer, Thymoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Nagla Abdel KarimUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bosutinib and Pemetrexed | Experimental | Drug: Bosutinib, Drug: PemetrexedBosutinib and pemetrexed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Untreated or symptomatic brain metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bosutinib100mg daily for 4 cycles (21 days per cycle) | Drug | Bosutinib and Pemetrexed |
| Pemetrexed500 mg/m2 every 21 days for 4 cycles | Drug | Bosutinib and Pemetrexed |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nagla Karim, MD principal investigator
Augusta University Georgia Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bosutinib and Pemetrexed in people with Carcinoma, Non-Small-Cell Lung and Mesothelioma, run by Nagla Abdel Karim at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity of the combination of bosutinib and pemetrexed (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.