Advanced Solid TumorsPhase 1NCT02622932

Study to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer Patients

A Phase 1 study testing Anlotinib and 14C-labeled Anlotinib in people with Advanced Solid Tumors, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer patients. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Advanced Solid Tumors
What is being tested?: Anlotinib and 14C-labeled Anlotinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteChina
Study dates: 2 Dec 2015to Aug 2017
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

signed and dated informed consent
histologically or cytologically confirmed diagnosis of advanced solid tumor (including RCC、NSCLC、STS and CRC)
failed to the treatment of line 1 or 2
ECOG PS:0-1,Life expectancy of more than 3 months
main organs function is normal

Who cannot join

prior treatment with Anlotinib or Allergic to drug or its formulation ingredients
subjects with the gastrointestinal tract, liver and kidney disease of affect drug absorption and metabolism
CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous treatments
patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2 or higher dyspnea [Grade 2 dyspnea refers to Shortness of breath with a small amount of activities, affecting Instrumental activities of daily life])
patients underwent major surgical treatment，open biopsy or significant traumatic injury within 28 days prior to assignment

Trial locations and contacts

1 site in 1 country.

China1 site

Jiangsu Province Hospital
Nanjing, Jiangsu, 210029

Other trials in China

About this study

Official title: A Phase 1, Open-label Study to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer Patients

The purpose of this study is to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer patients.

Conditions: Advanced Solid Tumors
Being tested: Anlotinib and 14C-labeled Anlotinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anlotinib and 14C-labeled AnlotinibDrug
oral

Study groups in NCT02622932
Study group	Role	What they receive
Anlotinib and 14C-labeled Anlotinib	Experimental	each participant will be given a single dose of 14C-labeled gilteritinib. Receives: Drug: Anlotinib and 14C-labeled Anlotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Cumulative excretion of 14C-labeled Anlotinib (radioactivity in urine)
Measured: up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
Cumulative excretion of 14C-labeled Anlotinib (radioactivity in feces)
Measured: up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
Excretion rate of 14C-labeled Anlotinib (radioactivity in urine)
Measured: up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
Excretion rate of 14C-labeled Anlotinib (radioactivity in feces)
Measured: up to 10 Days (endpoint when the two consecutive time points of cumulative excretion <1%)
Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood):Peak Plasma Concentration(Cmax)
Peak Plasma Concentration(Cmax),Cmax in ng/mL,
Measured: up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood):Peak time（Tmax）
Peak time（Tmax）,Tmax in h.
Measured: up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood):Half life（t1/2）
Half life（t1/2）,t1/2 in h.
Measured: up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood): Area under the plasma concentration versus time curve (AUC)
Area under the plasma concentration versus time curve (AUC), AUC in ng.h/mL.
Measured: up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood): Clearance（CL）
Clearance（CL）,CL in L/h.
Measured: up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

Secondary outcomes (1)

Metabolite identification of Anlotinib in plasma, urine and feces
Measured: up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Dec 2015Aug 2017

First posted7 Dec 2015 (estimated)
Study start2 Dec 2015
Primary completion30 Dec 2016
Study completionAug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02622932
Sponsor's protocol ID: ALTN-I-R
Status last verified: Apr 2019
First submitted: 2 Dec 2015
Last updated: 30 Apr 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label Study to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer Patients
ClinicalTrials.gov ID: NCT02622932
Acronym / sponsor ID: ALTN-I-R
Conditions: Advanced Solid Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
Study start: 2 Dec 2015 (actual)
Primary completion: 30 Dec 2016 (actual)
Study completion: Aug 2017 (actual)
First posted: 7 Dec 2015 (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 Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer patients.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Anlotinib and 14C-labeled Anlotinib	Experimental	Drug: Anlotinib and 14C-labeled Anlotinibeach participant will be given a single dose of 14C-labeled gilteritinib.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

signed and dated informed consent
histologically or cytologically confirmed diagnosis of advanced solid tumor (including RCC、NSCLC、STS and CRC)
failed to the treatment of line 1 or 2
ECOG PS:0-1,Life expectancy of more than 3 months
main organs function is normal

Key exclusion criteria (5 listed)

prior treatment with Anlotinib or Allergic to drug or its formulation ingredients
subjects with the gastrointestinal tract, liver and kidney disease of affect drug absorption and metabolism
CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous treatments
patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2 or higher dyspnea [Grade 2 dyspnea refers to Shortness of breath with a small amount of activities, affecting Instrumental activities of daily life])
patients underwent major surgical treatment，open biopsy or significant traumatic injury within 28 days prior to assignment

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
Anlotinib and 14C-labeled Anlotiniboral	Drug	Anlotinib and 14C-labeled Anlotinib

Primary outcome

Cumulative excretion of 14C-labeled Anlotinib (radioactivity in urine)
Time frame: up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
Cumulative excretion of 14C-labeled Anlotinib (radioactivity in feces)
Time frame: up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
Excretion rate of 14C-labeled Anlotinib (radioactivity in urine)
Time frame: up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
Excretion rate of 14C-labeled Anlotinib (radioactivity in feces)
Time frame: up to 10 Days (endpoint when the two consecutive time points of cumulative excretion <1%)
Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood):Peak Plasma Concentration(Cmax)
Time frame: up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Peak Plasma Concentration(Cmax),Cmax in ng/mL,
Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood):Peak time（Tmax）
Time frame: up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Peak time（Tmax）,Tmax in h.
Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood):Half life（t1/2）
Time frame: up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Half life（t1/2）,t1/2 in h.
Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood): Area under the plasma concentration versus time curve (AUC)
Time frame: up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Area under the plasma concentration versus time curve (AUC), AUC in ng.h/mL.
Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood): Clearance（CL）
Time frame: up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Clearance（CL）,CL in L/h.

1 secondary outcome

Metabolite identification of Anlotinib in plasma, urine and feces
Time frame: up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)

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 30 Apr 2019.
Individual participant dataSharing planned: Undecided

Related trials for Advanced Solid Tumors

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

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.

Lihua Bao, Doctor study director

The First Affiliated Hospital with Nanjing Medical University

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 Anlotinib and 14C-labeled Anlotinib in people with Advanced Solid Tumors, run by Chia Tai Tianqing Pharmaceutical Group 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 5 inclusion and 5 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 30 Apr 2019. 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?

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?

Cumulative excretion of 14C-labeled Anlotinib (radioactivity in urine) (time frame: up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)). The study lists 9 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 NCT02622932.

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 30 Apr 2019.