Advanced Solid TumorsPhase 1NCT01847118
A Phase Ia, Dose Escalation Study of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study testing Sevacizumab in people with Advanced Solid Tumors and Metastatic Solid Tumors, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is to assess the safety, tolerability and pharmacokinetics of single dose and multiple doses of humanized anti-VEGF monoclonal antibody (Sevacizumab) in patients with advanced or metastatic solid tumors. The secondary objective is to explore the preliminary anti-tumor effects. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Advanced Solid Tumors, Metastatic Solid Tumors
- What is being tested?
- Sevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Nov 2015
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed advanced or metastatic malignant solid tumors;
- Patients failed the standard anti-tumor therapy or don't have standard regimen;
- At least one measurable lesion;
- At least 4 weeks from the last chemotherapy, 6 weeks from mitomycin, and nitrosourea treatment. If patients received anti-tumor biological products, at least four t1/2 of washout period is needed;
- Toxicity from previous treatment has to restore to ≤ grade 1 (NCI CTC4.0);
- ECOG performance status 0-1;
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- Life expectancy ≥ 3 months;
- Adequate hematologic function: ANC ≥ 1.5 × 10^9 /L, HB ≥ 90 g /L (blood transfusion allowed), PLT ≥ 100 × 10^9 /L;
- Adequate hepatic function: ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN, TBIL ≤ 1.5 × ULN (patients with liver metastases ALT ≤ 5 × ULN, AST ≤ 5 × ULN, TBIL ≤ 3 × ULN);
- Adequate renal function: creatinine ≤ 1 × ULN;
- Coagulation function: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN;
- Patients of childbearing potential (male and female) must agree to use reliable methods of contraception until at least 12 weeks after the last dose.
Who cannot join
- HCV, TP or HIV antibody positive;
- Previously received anti-VEGF protein drugs, such as bevacizumab;
- Histologically proven squamous cell lung cancer or squamous cell carcinoma of the head and neck;
- Active hepatitis B infection;
- Evidence of serious infection;
- Symptomatic brain metastases;
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- Patients with proteinuria at screening (urine protein ≥ 1+);
- History of abdominal fistula, gastrointestinal perforation, abdominal abscess within 6 months prior to enrollment;
- Serious non-healing wounds, ulcers or fractures;
- Major surgery (excluding biopsy) or significant trauma within 4 weeks prior to enrollment;
- Active bleeding within 3 months prior to enrollment;
- Bleeding diathesis or coagulation disorder;
- History of arterial or venous thrombosis;
- History of myocardial infarction or stroke within 6 months prior to enrollment;
- Unstable angina, congestive heart failure, New York Heart Association (NYHA) class II heart failure, uncontrollable arrhythmia, uncontrolled hypertension (systolic blood pressure> 150 mmHg and/or diastolic blood pressure> 100 mmHg);
- Pregnant and lactating women;
- Known allergies to any excipient in the study drug;
- Patients with alcohol or drug dependence;
- Participation in other clinical trials within 4 weeks before enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Jin Li, MD, PhD, 86-021-61733905
About this study
This study is to assess the safety, tolerability and pharmacokinetics of single dose and multiple doses of humanized anti-VEGF monoclonal antibody (Sevacizumab) in patients with advanced or metastatic solid tumors. The secondary objective is to explore the preliminary anti-tumor effects.
- Conditions
- Advanced Solid Tumors, Metastatic Solid Tumors
- Being tested
- Sevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevacizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Sevacizumab | Experimental | 2mg/kg、5mg/kg、7.5mg/kg、10mg/kg、12.5mg/kg、or 15mg/kg. d1, d29, d43, d57 Receives: Drug: Sevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
Measured: up to 28 days
Secondary outcomes (6)
Cmax
Measured: d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57
tmax
Measured: d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57
AUC
Measured: d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57
t1/2
Measured: d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57
Objective Response Rate (ORR)
Measured: d29, d86
Disease Control Rate (DCR)
Measured: d29, d86
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
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 Jiangsu Simcere Pharmaceutical 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
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Li, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847118
- Sponsor's protocol ID
- SIM-63-001
- Status last verified
- Jul 2014
- First submitted
- 26 Apr 2013
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia, Dose Escalation Study of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT01847118
- Acronym / sponsor ID
- SIM-63-001
- Conditions
- Advanced Solid Tumors, Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 6 May 2013 (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 study is to assess the safety, tolerability and pharmacokinetics of single dose and multiple doses of humanized anti-VEGF monoclonal antibody (Sevacizumab) in patients with advanced or metastatic solid tumors. The secondary objective is to explore the preliminary anti-tumor effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sevacizumab | Experimental | Drug: Sevacizumab2mg/kg、5mg/kg、7.5mg/kg、10mg/kg、12.5mg/kg、or 15mg/kg. d1, d29, d43, d57 |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically or cytologically confirmed advanced or metastatic malignant solid tumors;
- Patients failed the standard anti-tumor therapy or don't have standard regimen;
- At least one measurable lesion;
- At least 4 weeks from the last chemotherapy, 6 weeks from mitomycin, and nitrosourea treatment. If patients received anti-tumor biological products, at least four t1/2 of washout period is needed;
- Toxicity from previous treatment has to restore to ≤ grade 1 (NCI CTC4.0);
Key exclusion criteria (19 listed)
- HCV, TP or HIV antibody positive;
- Previously received anti-VEGF protein drugs, such as bevacizumab;
- Histologically proven squamous cell lung cancer or squamous cell carcinoma of the head and neck;
- Active hepatitis B infection;
- Evidence of serious infection;
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 |
|---|---|---|
| Sevacizumab | Drug | Sevacizumab |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: up to 28 days
6 secondary outcomes
Cmax
Time frame: d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57
tmax
Time frame: d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57
AUC
Time frame: d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57
t1/2
Time frame: d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57
Objective Response Rate (ORR)
Time frame: d29, d86
Disease Control Rate (DCR)
Time frame: d29, d86
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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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, MD, 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 Sevacizumab in people with Advanced Solid Tumors and Metastatic Solid Tumors, run by Jiangsu Simcere Pharmaceutical 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 12 inclusion and 19 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 24 Mar 2015. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: up to 28 days). 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 24 Mar 2015.