Malignant MelanomaPhase 2NCT03383237
Clinical Study of Apatinib as the Second-line Therapy in Malignant Melanoma
A Phase 2 study testing Apatinib in people with Malignant Melanoma, run by Henan Cancer Hospital at 1 site in China.
Trial summary
The purpose of this study is to confirm the safety and efficacy of Apatinib as the Second-line Therapy in Malignant Melanoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- Apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 29 Nov 2017to Nov 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed the informed consent form prior to patient entry.
- Pathologically confirmed first-line treatment of advanced malignant melanoma patients with at least one measurable lesion.
- ≥ 18 and ≤ 70 years of age.
- Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
- Life expectancy of more than 3 months.
- Adequate hepatic, renal, heart, and hematologic functions: ANC ≥ 1.5×109/L, PLT ≥ 100×109/L, HB ≥ 90 g/L, TBIL ≤ 1.5×ULN, ALT or AST ≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Serum Cr ≤ 1.5×ULN, Cr clearance ≥ 60 mL/min;Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%).
- Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 6 months after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 6 months after last dose of study drug.
Who cannot join
- uncontrollable hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, despite optimal medical therapy), grade II The above myocardial ischemia or myocardial infarction, poor control of arrhythmia (including QTc interval male ≥ 450 ms, female ≥ 470 ms).
- Patients previously treated with anticancer therapies also have a Toxicity Level> 1 in NCI CTCAE.
- A variety of factors that affect oral absorption (such as inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.).
- Patients with gastrointestinal bleeding risk may not be included, including the following: (1) active peptic ulcer lesions and fecal occult blood (++); (2) history of melena and vomiting within 3 months; (3) ) For fecal occult blood (+) must be gastroscopy, clear whether the existence of gastrointestinal organic diseases.
- Coagulation dysfunction (INR> 1.5, PT> ULN + 4s or APTT> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment.
- Long-term, unhealed wounds or fractures.
Show all 18Show fewer
- Active bleeding, within 30 days after major surgery.
- Intracranial metastasis.
- Pregnant or lactating women.
- Cytotoxic drug treatment, radiotherapy within 3 weeks after treatment; had taken two or more targeted drugs, or into the group before the other three months have been taking other targeted drugs.
- Other malignant tumors in the past 3 years.
- The investigators believe there is any condition that may harm the subject or result in the subject's inability to meet or perform the research requirements.
- Huge metastasis / recurrence (tumor diameter> 5 cm)。
- Malignant pleural effusion or ascites, causing NCI CTCAE grading 2 or more people with dyspnea.
- Any allergy to apatinib should be excluded.
- Severe liver and kidney dysfunction (grade 4) patients should be excluded.
- Persons with a history of substance abuse who can not be abdicated or have mental disorders.
- According to the judgment of the researcher, there is a concomitant disease that seriously endangers the patient's safety or affects the patient in completing the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Zibing Wang
About this study
Official title: Clinical Study of Apatinib as the Second-line Therapy in Malignant Melanoma：An Open-Label, Single-center, Single-arm Study
The purpose of this study is to confirm the safety and efficacy of Apatinib as the Second-line Therapy in Malignant Melanoma.
Read the detailed description
Melanoma is a malignant tumor caused by hyperplasia of abnormal melanoma cells.Most of the adults above 30 years of age occur in the skin, mucosa and internal organs. The investigators designed the study to explore the possibility of apatinib as the Second-line Therapy in Malignant Melanoma.
- Conditions
- Malignant Melanoma
- Being tested
- Apatinib
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
500mg/d,q.d.,p.o.
| Study group | Role | What they receive |
|---|---|---|
| Apatinib | Experimental | Apatinib 500mg/d,q.d.,p.o. Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
From date of randomization until the date of first documented progression or date of death from any cause
Measured: up to 2 year
Secondary outcomes (3)
Objective Response Rate (ORR)
From date of randomization until the date of death from any cause
Measured: up to 1 year
Disease Control Rate (DCR)
Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
Measured: up to 1 year
Overall survival(OS)
From date of randomization until the date of death from any cause
Measured: up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start29 Nov 2017
- Primary completionNov 2018 (estimated)
- Study completionNov 2019 (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 Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Zibing Wang, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383237
- Sponsor's protocol ID
- AHEAD-HNP051
- Status last verified
- Nov 2017
- First submitted
- 18 Dec 2017
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yuan S, Fu Q, Zhao L, Fu X, Li T, Han L, Qin P, Ren Y, Huo M, Li Z, Lu C, Yuan L, Gao Q, Wang Z. Efficacy and Safety of Apatinib in Patients with Recurrent or Refractory Melanoma. Oncologist. 2022 Jun 8;27(6):e463-e470. doi: 10.1093/oncolo/oyab068.
PubMed 35348754
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Apatinib as the Second-line Therapy in Malignant Melanoma：An Open-Label, Single-center, Single-arm Study
- ClinicalTrials.gov ID
- NCT03383237
- Acronym / sponsor ID
- AHEAD-HNP051
- Conditions
- Malignant Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 26 Dec 2017 (actual)
- 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 confirm the safety and efficacy of Apatinib as the Second-line Therapy in Malignant Melanoma.
Detailed description
Melanoma is a malignant tumor caused by hyperplasia of abnormal melanoma cells.Most of the adults above 30 years of age occur in the skin, mucosa and internal organs. The investigators designed the study to explore the possibility of apatinib as the Second-line Therapy in Malignant Melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib | Experimental | Drug: ApatinibApatinib 500mg/d,q.d.,p.o. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed the informed consent form prior to patient entry.
- Pathologically confirmed first-line treatment of advanced malignant melanoma patients with at least one measurable lesion.
- ≥ 18 and ≤ 70 years of age.
- Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
- Life expectancy of more than 3 months.
Key exclusion criteria (18 listed)
- uncontrollable hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, despite optimal medical therapy), grade II The above myocardial ischemia or myocardial infarction, poor control of arrhythmia (including QTc interval male ≥ 450 ms, female ≥ 470 ms).
- Patients previously treated with anticancer therapies also have a Toxicity Level> 1 in NCI CTCAE.
- A variety of factors that affect oral absorption (such as inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.).
- Patients with gastrointestinal bleeding risk may not be included, including the following: (1) active peptic ulcer lesions and fecal occult blood (++); (2) history of melena and vomiting within 3 months; (3) ) For fecal occult blood (+) must be gastroscopy, clear whether the existence of gastrointestinal organic diseases.
- Coagulation dysfunction (INR> 1.5, PT> ULN + 4s or APTT> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment.
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 |
|---|---|---|
| Apatinib500mg/d,q.d.,p.o. | Drug | Apatinib |
Primary outcome
Progression-free Survival (PFS)
Time frame: up to 2 year
From date of randomization until the date of first documented progression or date of death from any cause
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: up to 1 year
Disease Control Rate (DCR)
Time frame: up to 1 year
Overall survival(OS)
Time frame: up to 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
- Derived from this study: PubMed 35348754Yuan S, Fu Q, Zhao L, Fu X, Li T, Han L, Qin P, Ren Y, Huo M, Li Z, Lu C, Yuan L, Gao Q, Wang Z. Efficacy and Safety of Apatinib in Patients with Recurrent or Refractory Melanoma. Oncologist. 2022 Jun 8;27(6):e463-e470. doi: 10.1093/oncolo/oyab068.
Related trials for Malignant Melanoma
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
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
Zibing Wang principal investigator
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib in people with Malignant Melanoma, run by Henan Cancer Hospital 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 18 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 27 Dec 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zibing Wang (18937621301, bingziwang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: up to 2 year). 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 NCT03383237, 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 27 Dec 2017.