Non Small Cell Lung CancerPhase 1NCT04173338
Cabozantinib With Pemetrexed in Advanced Non-small Cell Lung Cancer, Urothelial Cancer and Malignant Mesothelioma
A Phase 1 study testing Cabozantinib and Pemetrexed in people with Non Small Cell Lung Cancer and Non-squamous Non-small-cell Lung Cancer, run by Augusta University at 1 site in United States.
Trial summary
This study will combine cabozantinib with pemetrexed to treat patients with non-small cell lung cancer, urothelial cancer and advanced malignant mesothelioma. This study will test the safety of both drugs used together and see what effect (good or bad) it has no participants and their cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Non-squamous Non-small-cell Lung Cancer, Urothelial Carcinoma
- What is being tested?
- Cabozantinib and Pemetrexed
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2020to 28 Mar 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
- Locally advanced NSCLC, urothelial cancer or malignant mesothelioma.
- 18 years or older.
- At least one prior chemotherapy before entering in this trial.
- Not pregnant or breastfeeding.
Who cannot join
- Prior treatment with cabozantinib.
- Currently receiving cancer treatment (last dose 2 weeks prior to enrollment in study).
- History of bleeding disorder/bleeding history within 12 weeks before first study treatment dose.
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 Cabozantinib in Combination With Pemetrexed in Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC), Urothelial Cancer and Advanced Malignant Mesothelioma
This study will combine cabozantinib with pemetrexed to treat patients with non-small cell lung cancer, urothelial cancer and advanced malignant mesothelioma. This study will test the safety of both drugs used together and see what effect (good or bad) it has no participants and their cancer.
- Conditions
- Non Small Cell Lung Cancer, Non-squamous Non-small-cell Lung Cancer, Urothelial Carcinoma, Malignant Mesothelioma
- Being tested
- Cabozantinib, Pemetrexed
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Transitional Cell, Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabozantinibDrug
start at 20mg then increase by 20mg every cycle or until there's a dose-limiting toxicity.
PemetrexedDrug
Start with 400mg/m2, then increase and maintain 500mg/m2 unless dose-limiting toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Cabozantinib + Pemetrexed | Experimental | Pemetrexed 500mg/m2 IV day 1 of each 21 day cycle + Cabozantinib 20-60mg by mouth once a day. Receives: Drug: Cabozantinib; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the maximum tolerated dose (MTD) of cabozantinib in combination with pemetrexed
Dose-limiting toxicity of grade 3 or higher using CTCAE 5
Measured: 4 weeks or 28 days assessment.
Secondary outcomes (3)
Assess objective response rate (RR)
RR measured by Tumor response evaluation with RECIST
Measured: To be measured through study completion; an average of 1 year.
Progression-free survival (PFS)
PFS measured from the time of study treatment to the date of progression.
Measured: To be measured through study completion; an average of 1 year.
Overall survival (OS).
Measured from the time of start of treatment to time of death or time of last assessment.
Measured: OS measured through study completion, and an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start23 Jan 2020
- Primary completion28 Mar 2022
- Study completion28 Mar 2022
Why it stopped: Closed by IRB on 3/28/22
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nagla Abdel Karim, Augusta University
- Investigators
- Nagla A Karim, MD, PhD, Principal investigator, Augusta University Georgia Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173338
- Sponsor's protocol ID
- IST-65
- Status last verified
- Jun 2022
- First submitted
- 14 Nov 2019
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 Cabozantinib in Combination With Pemetrexed in Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC), Urothelial Cancer and Advanced Malignant Mesothelioma
- ClinicalTrials.gov ID
- NCT04173338
- Acronym / sponsor ID
- IST-65
- Conditions
- Non Small Cell Lung Cancer, Non-squamous Non-small-cell Lung Cancer, Urothelial Carcinoma, Malignant Mesothelioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed by IRB on 3/28/22
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 21 Nov 2019 (actual)
- 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 combine cabozantinib with pemetrexed to treat patients with non-small cell lung cancer, urothelial cancer and advanced malignant mesothelioma. This study will test the safety of both drugs used together and see what effect (good or bad) it has no 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 |
|---|---|---|
| Cabozantinib + Pemetrexed | Experimental | Drug: Cabozantinib, Drug: PemetrexedPemetrexed 500mg/m2 IV day 1 of each 21 day cycle + Cabozantinib 20-60mg by mouth once a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Locally advanced NSCLC, urothelial cancer or malignant mesothelioma.
- 18 years or older.
- At least one prior chemotherapy before entering in this trial.
- Not pregnant or breastfeeding.
Key exclusion criteria (3 listed)
- Prior treatment with cabozantinib.
- Currently receiving cancer treatment (last dose 2 weeks prior to enrollment in study).
- History of bleeding disorder/bleeding history within 12 weeks before first study treatment dose.
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 |
|---|---|---|
| Cabozantinibstart at 20mg then increase by 20mg every cycle or until there's a dose-limiting toxicity. | Drug | Cabozantinib + Pemetrexed |
| PemetrexedStart with 400mg/m2, then increase and maintain 500mg/m2 unless dose-limiting toxicity. | Drug | Cabozantinib + Pemetrexed |
Primary outcome
Assess the maximum tolerated dose (MTD) of cabozantinib in combination with pemetrexed
Time frame: 4 weeks or 28 days assessment.
Dose-limiting toxicity of grade 3 or higher using CTCAE 5
3 secondary outcomes
Assess objective response rate (RR)
Time frame: To be measured through study completion; an average of 1 year.
Progression-free survival (PFS)
Time frame: To be measured through study completion; an average of 1 year.
Overall survival (OS).
Time frame: OS measured through study completion, and an average of 1 year
Results and safety
The study was stopped early (reason given: Closed by IRB on 3/28/22). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
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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 A Karim, MD, PhD 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 Cabozantinib and Pemetrexed in people with Non Small Cell Lung Cancer and Non-squamous Non-small-cell Lung Cancer, run by Augusta University 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 3 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: stopped early, 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 was stopped early (reason given: Closed by IRB on 3/28/22). Results are not available in the source record.
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?
Assess the maximum tolerated dose (MTD) of cabozantinib in combination with pemetrexed (time frame: 4 weeks or 28 days assessment.). 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.