TumorPhase 1NCT00633490
Study of Apatinib as an Inhibitor of Tumor Angiogenesis
A Phase 1 study testing apatinib in people with Tumor, run by Fudan University at 1 site in China.
Trial summary
Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), so it can inhibit tumor angiogenesis. This phase I study aims to determine the drug's toxicity and to find a dose level to be used in a phase II study in solid tumor patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tumor
- What is being tested?
- apatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- Jul 2007to Jun 2008
- 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
- ≥ 18 and ≤ 70 years of age
- Histological or cytological confirmed solid malignant tumor
- ECOG performance status of ≤ 2
- Standard regimen failed or no standard regimen available
- Life expectancy of more than 3 months
- Duration from the last therapy is more than 6 weeks for nitroso or mitomycin; more than 4 weeks for operation or radiotherapy; more than 4 weeks for cytotoxic agents or growth inhibitors.
- Laboratory values: hemoglobin ≥ 9.0g/dl, neutrophils ≥ 1.5×10^9/L, platelets ≥ 100×10^9/L , ALT ≤ 2.5 x upper limit of normal (ULN), AST ≤ 2.5 x ULN, serum bilirubin ≤ 1.5 x ULN, serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥ 50ml/min, PT, APTT, TT, Fbg normal
Who cannot join
- Pregnant or lactating women
- Any factors that influence the usage of oral administration
- Evidence of CNS metastasis
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
- Receiving the therapy of thrombolysis or anticoagulation
Show all 10Show fewer
- Abuse of alcohol or drugs
- Allergy to the ingredient of the agent or more than two kinds of food and drug
- Less than 4 weeks from the last clinical trial
- Disability of serious uncontrolled intercurrence infection
Trial locations and contacts
1 site in 1 country.
Jin Li, PhD contact
China1 site, 1 recruiting
- Recruiting
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Phase 1 Study of Apatinib as an Inhibitor of Angiogenesis
Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), so it can inhibit tumor angiogenesis. This phase I study aims to determine the drug's toxicity and to find a dose level to be used in a phase II study in solid tumor patients.
Read the detailed description
Apatinib is a tyrosin-inhibitor agent targeting at VEGFR (vasoendothelial growth factor receptor) to inhibit tumor angiogenesis. The anti-angiogenesis effect of apatinib has been viewed in preclinical tests (see protocol). This phase I clinical study is going to evaluate its toxicity and to find an appropriate dose level to be used in a phase II study in heavily treated solid tumor patients.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apatinibDrug
Also called mesylate apatinib
apatinib is a tablet in the form of 250mg and 100mg and 50mg, orally, daily
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
toxicity and tolerable dosage on the basis of NCI-CTCAE 3.0
Measured: 4 weeks
Secondary outcomes (1)
efficacy
Measured: every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startJul 2007
- Primary completionJun 2008 (estimated)
- Study completionJun 2008 (estimated)
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 TumorStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Investigators
- Jin Li, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633490
- Sponsor's protocol ID
- 2007APA
- Status last verified
- Mar 2008
- First submitted
- 24 Feb 2008
- Last updated
- 22 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Li J, Zhao X, Chen L, Guo H, Lv F, Jia K, Yv K, Wang F, Li C, Qian J, Zheng C, Zuo Y. Safety and pharmacokinetics of novel selective vascular endothelial growth factor receptor-2 inhibitor YN968D1 in patients with advanced malignancies. BMC Cancer. 2010 Oct 5;10:529. doi: 10.1186/1471-2407-10-529.
PubMed 20923544
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Apatinib as an Inhibitor of Angiogenesis
- ClinicalTrials.gov ID
- NCT00633490
- Acronym / sponsor ID
- 2007APA
- Conditions
- Tumor
- Keywords
- Toxicity, Efficacy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jun 2008 (estimated)
- Study completion
- Jun 2008 (estimated)
- First posted
- 12 Mar 2008 (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.
Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), so it can inhibit tumor angiogenesis. This phase I study aims to determine the drug's toxicity and to find a dose level to be used in a phase II study in solid tumor patients.
Detailed description
Apatinib is a tyrosin-inhibitor agent targeting at VEGFR (vasoendothelial growth factor receptor) to inhibit tumor angiogenesis. The anti-angiogenesis effect of apatinib has been viewed in preclinical tests (see protocol). This phase I clinical study is going to evaluate its toxicity and to find an appropriate dose level to be used in a phase II study in heavily treated solid tumor patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: apatinib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 18 and ≤ 70 years of age
- Histological or cytological confirmed solid malignant tumor
- ECOG performance status of ≤ 2
- Standard regimen failed or no standard regimen available
- Life expectancy of more than 3 months
Key exclusion criteria (10 listed)
- Pregnant or lactating women
- Any factors that influence the usage of oral administration
- Evidence of CNS metastasis
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
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 |
|---|---|---|
| apatinibAlso: mesylate apatinibapatinib is a tablet in the form of 250mg and 100mg and 50mg, orally, daily | Drug | A |
Primary outcome
toxicity and tolerable dosage on the basis of NCI-CTCAE 3.0
Time frame: 4 weeks
1 secondary outcome
efficacy
Time frame: every 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2008.
- Derived from this study: PubMed 20923544Li J, Zhao X, Chen L, Guo H, Lv F, Jia K, Yv K, Wang F, Li C, Qian J, Zheng C, Zuo Y. Safety and pharmacokinetics of novel selective vascular endothelial growth factor receptor-2 inhibitor YN968D1 in patients with advanced malignancies. BMC Cancer. 2010 Oct 5;10:529. doi: 10.1186/1471-2407-10-529.
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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.
Jin Li, PhD contact
Jin Li, PhD principal investigator
Fudan 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 apatinib in people with Tumor, run by Fudan University 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 7 inclusion and 10 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 22 Jul 2008. 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 Jin Li, PhD (jianggl@21cn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
toxicity and tolerable dosage on the basis of NCI-CTCAE 3.0 (time frame: 4 weeks). 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 NCT00633490, 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 22 Jul 2008.