Non-small Cell Lung CancerPhase 1NCT02695550
Study of Safety, Efficacy and Pharmacokinetics of CT-707 in Patients With ALK-positive Non-small Cell Lung Cancer
A Phase 1 study testing CT-707 in people with Non-small Cell Lung Cancer, run by Centaurus Biopharma Co., Ltd. at 1 site in China.
Trial summary
This is a Phase I study of the ALK/FAK/Pyk2 inhibitor CT-707 in patients with ALK-positive non-small cell lung cancer. The purpose of the study is to determine the MTD/RP2D of CT-707 and evaluate whether CT-707 is safe and has beneficial effects in ALK-positive advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- CT-707
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Mar 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be diagnosed with ALK-positive advanced NSCLC. The tumor must be ALK-positive as determined by ALK rearrangement in ≥15% of cells (as measured by FISH using the Vysis break-apart ALK probe) or by using the Ventana ALK IHC test. The analysis may be performed locally.
- Eastern cooperative oncology group (ECOG) performance status ≤ 2. Measurable disease as per RECIST v1.1
- Availability of tumor sample:
Who cannot join
- Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids or local CNS-directed therapy to control their CNS disease Impaired cardiac function or any clinically significant cardiac disease Patients with abnormal laboratory values during screening and on day 1 of pre-dose Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of CT-707 Patient has a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Yuankai Shi, M.D., 86(10)67781331, syuankaipumc@126.com
About this study
This is a Phase I study of the ALK/FAK/Pyk2 inhibitor CT-707 in patients with ALK-positive non-small cell lung cancer.
The purpose of the study is to determine the MTD/RP2D of CT-707 and evaluate whether CT-707 is safe and has beneficial effects in ALK-positive advanced non-small cell lung cancer.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- CT-707
- 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.
CT-707Drug
| Study group | Role | What they receive |
|---|---|---|
| CT-707 | Experimental | ALK-positive non-small cell lung cancer resistant to Crizotinib treatment Receives: Drug: CT-707 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)
Maximum Tolerated Dose(s) (MTD(s)) and/or recommended phase 2 dose (RP2D(s)) of CT-707 in ALK-positive non-small cell lung cancer (NSCLC) patients. Cycle = 28 days
Measured: 28 days
Frequency of adverse events/serious adverse events
Characterization of the safety and tolerability of CT-707 as determined by changes in laboratory values and electrocardiograms
Measured: Up to 24 months
Secondary outcomes (3)
Overall Response Rate (ORR) - Phase I
Preliminary measure of anti-tumor activity of CT-707
Measured: Up to 24 month
Progression free survival (PFS) per RECIST v1.1 - Phase I
Preliminary measures of anti-tumor activity of CT-707
Measured: Up to 24 months
Duration of response (DOR)
Preliminary measure of anti-tumor activity of CT-707
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centaurus Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, Dr, Principal investigator, Cancer Hospital of Chines Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695550
- Sponsor's protocol ID
- CT-707-101
- Status last verified
- Mar 2017
- First submitted
- 23 Feb 2016
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Xing P, Zhao Q, Zhang L, Wang H, Huang D, Hu P, Sun Y, Shi Y. Conteltinib (CT-707) in patients with advanced ALK-positive non-small cell lung cancer: a multicenter, open-label, first-in-human phase 1 study. BMC Med. 2022 Nov 23;20(1):453. doi: 10.1186/s12916-022-02646-0.
PubMed 36424628Liang C, Zhang N, Tan Q, Liu S, Luo R, Wang Y, Shi Y, Han X. CT-707 Overcomes Resistance of Crizotinib through Activating PDPK1- AKT1 Pathway by Targeting FAK. Curr Cancer Drug Targets. 2019;19(8):655-665. doi: 10.2174/1568009618666181031152140.
PubMed 30381078
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Safety, Efficacy and Pharmacokinetics of CT-707 in Patients With ALK-positive Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02695550
- Acronym / sponsor ID
- CT-707-101
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centaurus Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 1 Mar 2016 (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 is a Phase I study of the ALK/FAK/Pyk2 inhibitor CT-707 in patients with ALK-positive non-small cell lung cancer.
The purpose of the study is to determine the MTD/RP2D of CT-707 and evaluate whether CT-707 is safe and has beneficial effects in ALK-positive advanced non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT-707 | Experimental | Drug: CT-707ALK-positive non-small cell lung cancer resistant to Crizotinib treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be diagnosed with ALK-positive advanced NSCLC. The tumor must be ALK-positive as determined by ALK rearrangement in ≥15% of cells (as measured by FISH using the Vysis break-apart ALK probe) or by using the Ventana ALK IHC test. The analysis may be performed locally.
- Eastern cooperative oncology group (ECOG) performance status ≤ 2. Measurable disease as per RECIST v1.1
Key exclusion criteria (2 listed)
- Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids or local CNS-directed therapy to control their CNS disease Impaired cardiac function or any clinically significant cardiac disease Patients with abnormal laboratory values during screening and on day 1 of pre-dose Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of CT-707 Patient has a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| CT-707 | Drug | CT-707 |
Primary outcome
Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)
Time frame: 28 days
Maximum Tolerated Dose(s) (MTD(s)) and/or recommended phase 2 dose (RP2D(s)) of CT-707 in ALK-positive non-small cell lung cancer (NSCLC) patients. Cycle = 28 days
Frequency of adverse events/serious adverse events
Time frame: Up to 24 months
Characterization of the safety and tolerability of CT-707 as determined by changes in laboratory values and electrocardiograms
3 secondary outcomes
Overall Response Rate (ORR) - Phase I
Time frame: Up to 24 month
Progression free survival (PFS) per RECIST v1.1 - Phase I
Time frame: Up to 24 months
Duration of response (DOR)
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Derived from this study: PubMed 36424628Xing P, Zhao Q, Zhang L, Wang H, Huang D, Hu P, Sun Y, Shi Y. Conteltinib (CT-707) in patients with advanced ALK-positive non-small cell lung cancer: a multicenter, open-label, first-in-human phase 1 study. BMC Med. 2022 Nov 23;20(1):453. doi: 10.1186/s12916-022-02646-0.
- Derived from this study: PubMed 30381078Liang C, Zhang N, Tan Q, Liu S, Luo R, Wang Y, Shi Y, Han X. CT-707 Overcomes Resistance of Crizotinib through Activating PDPK1- AKT1 Pathway by Targeting FAK. Curr Cancer Drug Targets. 2019;19(8):655-665. doi: 10.2174/1568009618666181031152140.
- 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.
Yuankai Shi, Dr principal investigator
Cancer Hospital of Chines Academy of Medical Sciences
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 CT-707 in people with Non-small Cell Lung Cancer, run by Centaurus Biopharma Co., Ltd. at 1 site in China.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Mar 2017. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Peng, Dr. (86(10)88858866, ypeng@centaurusbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I) (time frame: 28 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?
On the ClinicalTrials.gov record for NCT02695550, which also lists 2 linked publications.
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 9 Mar 2017.