Carcinoma, Non-Small-Cell LungPhase 2NCT00522145
Study of XL647 in Subjects With NSCLC Who Have Progressed After Responding to Treatment With Gefitinib or Erlotinib
A Phase 2 study testing XL647 in people with Carcinoma, Non-Small-Cell Lung, run by Kadmon Corporation, LLC at 10 sites in United States.
Trial summary
The purpose of this study is to determine the best confirmed response rate of daily administration of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR and VEGFR2) XL647 in subjects with NSCLC who have progressed after responding to treatment with either erlotinib or gefitinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- XL647
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 10 sitesUnited States
- Study dates
- May 2007to Feb 2010
- Phase
- Phase 2
- 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
- Histologically confirmed diagnosis of unresectable Stage IIIB or Stage IV relapsed or recurrent NSCLC.
- Subjects must have:
- documented (radiological or clinical) progressive disease (PD) following a prior response (including stable disease) to monotherapy with erlotinib or gefitinib that was administered for at least 12 weeks prior to progression OR
- a documented T790M EGFR mutation
- Measurable disease defined according to RECIST
- ECOG performance status of 0 or 1.
- Sexually active subjects must use an accepted method of contraception during the course of the study.
- Female subjects of childbearing potential must have a negative pregnancy test at enrollment.
Who cannot join
- Received radiation to ≥25% of his or her bone marrow within 30 days of XL647 treatment.
- Received erlotinib or gefitinib, or other anticancer therapy within 14 days of the first dose of study drug.
- Received an investigational drug (excluding erlotinib or gefitinib) within 30 days of the first dose of study drug.
- Receiving anticoagulation therapy with warfarin.
- Not recovered to Grade ≤1 from adverse events (AEs) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study enrollment.
- Corrected QT interval (QTc) of >0.45 seconds.
- Progressive, symptomatic, or hemorrhagic brain or leptomeningeal metastases.
- Requires steroid or anticonvulsant therapy for the treatment of brain metastases.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Case Western Reserve University, University Hospitals of Cleveland
Cleveland, Ohio, 44106
Wayne State University, Wertz Clinical Cancer Center, Karmanos Center
Detroit, Michigan, 48201
Ronald Yanagihara
Gilroy, California, 95020
Washington County Hospital, The Center for Clinical Research
Hagerstown, Maryland, 21740
Signal Point Clinical Research Center
Middletown, Ohio, 45042
Cancer Care Center, Inc. P.C.
New Albany, Indiana, 47150
New Bern Cancer Care Oncology
New Bern, North Carolina, 28560
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
University of California Davis Cancer Center
Sacramento, California, 95817
Oncology Division and General Clincial Research, Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: A Phase 2 Study of XL647 in Subjects With Non-Small Cell Lung Cancer Who Have Progressed After Responding to Treatment With Either Gefitinib or Erlotinib
The purpose of this study is to determine the best confirmed response rate of daily administration of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR and VEGFR2) XL647 in subjects with NSCLC who have progressed after responding to treatment with either erlotinib or gefitinib.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- XL647
- Keywords
- Non-Small-Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XL647Drug
Also called KD019
Daily dosing as a single oral agent at a dose of 300 mg supplied as 50-mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Drug: XL647 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the best confirmed response rate
Measured: Inclusion until disease progression
Secondary outcomes (3)
Safety and tolerability of XL647 administered daily
Measured: First treatment until 30 day post last treatment
Progression-free survival, duration of response, and overall survival
Measured: Incusion until disease progression
Further characterize the pharmacokinetic (PK) parameters
Measured: Every 8 weeks after Day 57 until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2007 (estimated)
- Study startMay 2007
- Primary completionOct 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kadmon Corporation, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522145
- Sponsor's protocol ID
- XL647-203
- Status last verified
- May 2022
- First submitted
- 27 Aug 2007
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pietanza MC, Lynch TJ Jr, Lara PN Jr, Cho J, Yanagihara RH, Vrindavanam N, Chowhan NM, Gadgeel SM, Pennell NA, Funke R, Mitchell B, Wakelee HA, Miller VA. XL647--a multitargeted tyrosine kinase inhibitor: results of a phase II study in subjects with non-small cell lung cancer who have progressed after responding to treatment with either gefitinib or erlotinib. J Thorac Oncol. 2012 Jan;7(1):219-26. doi: 10.1097/JTO.0b013e31822eebf9.
PubMed 22011666
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of XL647 in Subjects With Non-Small Cell Lung Cancer Who Have Progressed After Responding to Treatment With Either Gefitinib or Erlotinib
- ClinicalTrials.gov ID
- NCT00522145
- Acronym / sponsor ID
- XL647-203
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Non-Small-Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Kadmon Corporation, LLCIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 29 Aug 2007 (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.
The purpose of this study is to determine the best confirmed response rate of daily administration of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR and VEGFR2) XL647 in subjects with NSCLC who have progressed after responding to treatment with either erlotinib or gefitinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: XL647 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed diagnosis of unresectable Stage IIIB or Stage IV relapsed or recurrent NSCLC.
- Subjects must have:
- Measurable disease defined according to RECIST
- ECOG performance status of 0 or 1.
- Sexually active subjects must use an accepted method of contraception during the course of the study.
Key exclusion criteria (8 listed)
- Received radiation to ≥25% of his or her bone marrow within 30 days of XL647 treatment.
- Received erlotinib or gefitinib, or other anticancer therapy within 14 days of the first dose of study drug.
- Received an investigational drug (excluding erlotinib or gefitinib) within 30 days of the first dose of study drug.
- Receiving anticoagulation therapy with warfarin.
- Not recovered to Grade ≤1 from adverse events (AEs) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study enrollment.
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 |
|---|---|---|
| XL647Also: KD019Daily dosing as a single oral agent at a dose of 300 mg supplied as 50-mg tablets | Drug | Group 1 |
Primary outcome
Determine the best confirmed response rate
Time frame: Inclusion until disease progression
3 secondary outcomes
Safety and tolerability of XL647 administered daily
Time frame: First treatment until 30 day post last treatment
Progression-free survival, duration of response, and overall survival
Time frame: Incusion until disease progression
Further characterize the pharmacokinetic (PK) parameters
Time frame: Every 8 weeks after Day 57 until disease progression
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 13 May 2022.
- Background: PubMed 22011666Pietanza MC, Lynch TJ Jr, Lara PN Jr, Cho J, Yanagihara RH, Vrindavanam N, Chowhan NM, Gadgeel SM, Pennell NA, Funke R, Mitchell B, Wakelee HA, Miller VA. XL647--a multitargeted tyrosine kinase inhibitor: results of a phase II study in subjects with non-small cell lung cancer who have progressed after responding to treatment with either gefitinib or erlotinib. J Thorac Oncol. 2012 Jan;7(1):219-26. doi: 10.1097/JTO.0b013e31822eebf9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XL647 in people with Carcinoma, Non-Small-Cell Lung, run by Kadmon Corporation, LLC at 10 sites 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 8 inclusion and 8 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 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Determine the best confirmed response rate (time frame: Inclusion until disease progression). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00522145, which also lists 1 linked publication.
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 13 May 2022.