Unrecognized ConditionPhase 1NCT04213612

DCV in the Treatment of Recurrence and Refractory Childhood Solid Tumors

A Phase 1 study testing pegylated liposomal doxorubicin, cyclophosphamide, vincristine, in people with Unrecognized Condition, run by Sun Yat-sen University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Doxorubicin is an anthracycline antibiotic that is part of the standard treatment for many pediatric malignancies, but its long-term cardiotoxicity cannot be ignored. Without affecting overall survival, in order to improve the quality of life of childhood tumor survivors and reduce cardiotoxicity, drugs with less… Read more about this study

Who is it for?: Ages 1 year to 18 years
Conditions the study is for: Unrecognized Condition
What is being tested?: pegylated liposomal doxorubicin, cyclophosphamide, vincristine,
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: No sites listed yet
Study dates: 30 Dec 2019to 30 Nov 2020
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 1 year to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

1) Age: 1-18 years;
2) ECOG PS score: 0-1 points;
3) Patients with solid tumors confirmed by histopathology in children;
4) Patients who have progressed, relapsed, or are refractory after first-line treatment (there is no complete or partial response after recent treatment);
5) Must have at least one measurable lesion as defined by the RECIST standard;
6) Expected survival time ≥ 6 months;

Show all 27Show fewer

7) Heart function:
Cardiac ultrasound detection LVEF ≥ 50%;
EKG indicates no myocardial ischemia;
no history of arrhythmia requiring drug intervention before enrollment;
8) Patients must fully recover from the acute toxic effects of all previous anti-cancer chemotherapy:
Myelosuppressive chemotherapy: at least 21 days after the last myelosuppressive chemotherapy (42 days if nitrosourea was used earlier);
Experimental drugs or anti-cancer therapies other than chemotherapy: Do not use within the first 28 days of the planned start of doxycycline. Full recovery from the clinically significant toxicity of the therapy must be clearly identified;
Hematopoietic growth factor: at least 14 days after the last dose of long-acting growth factor or 3 days after the last dose of short-acting growth factor;
immunotherapy: at least 42 days after completing any type of immunotherapy (except steroids), such as immune checkpoint inhibitors and tumor vaccines;
X-ray therapy (XRT): at least 14 days after local palliative XRT ( small range of mouth); if other solid bone marrow (BM) irradiation, including prior radioactive iodized meta-iodobenzidine (131I-MIBG) treatment, You must end at least 42 days;
Stem cell infusion without total body irradiation (TBI): There is no evidence of active graft-versus-host disease, and transplantation or stem cell infusion must end at least 56 days;
9) For patients who are not known to have BM:
Absolute neutrophil count (ANC) ≥ 1.0 × 109 / L;
Platelet count ≥100.0 × 109 / L;
hemoglobin ≥90 g / L;
10) Liver and kidney function should meet the following standards:
Bilirubin (combined + unbound total) ≤ 2.5 × upper limit of normal value (ULN) (corresponding to age), patients with Gilbert's syndrome can be enrolled according to the researchers' judgment
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;
Estimated glomerular filtration rate ≥ 30 mL / min / 1.73 m2 or serum creatinine (Cr) ≤ 1.5ULN;
11) During the participation in the study, be able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits;
12) The parent/ guardian of the child or adolescent subject has the ability to understand, agree, and sign the research informed consent (ICF) and applicable child consent form before initiating any protocol-related procedures; subject to parent/ guardian consent Candidates have the ability to express consent (if applicable).

Who cannot join

1) Previous or concurrent active clinical cardiovascular disease including congenital heart disease or pericardial disease, history of heart failure, myocardial infarction, coronary heart disease, heart valve disease, cardiomyopathy, arrhythmia (including persistent atrial fibrillation, Complete left bundle branch block, frequent ventricular early); or the QT interval (QTc) after the current corrected heart rate is extended> 480 milliseconds;
2) previous severe skin diseases;
3) previous allergic asthma or severe allergic disease;
4) Poorly controlled hypertension and diabetes;
5) Have a history of other tumors, except for cured cervical cancer or skin basal cell carcinoma;
6) Patients with hepatitis B surface antigen-positive;

Show all 12Show fewer

7) Patients infected with HIV or syphilis;
8) Patients who have received organ transplants in the past;
9) Uncontrolled active systemic bacterial, viral or fungal infections;
10) Contraindications to high-dose hormone use, such as uncontrollable high blood sugar, gastric ulcer or mental illness;
11) Patients who have used a total cumulative dose of doxorubicin ≥ 450 mg / m2, or a total cumulative dose of epirubicin ≥ 550 mg / m2, or previously used anthracyclines to cause heart disease;
12) Have a serious neurological or psychiatric history, including epilepsy or autism.

Trial locations and contacts

No sites are listed yet.

Yizhuo Zhang contact

02087342459

zhangyzh@sysucc.org.cn

About this study

Official title: Phase I Study of Pegylated Liposomal Doxorubicin Combined With Cyclophosphamide and Vincristine in Treatment Progress, Relapse, and Refractory Solid Tumors in Children

PEGylated doxorubicin (Caelyx®) has undergone a Phase I dose climbing clinical trial in children with solid tumors. The drug is safe by testing PK. The results of Phase II clinical studies of Caelyx® in children with progressive soft tissue sarcoma show that the drug is safe. Domestically produced PEGylated doxorubicin has no data on childhood tumors in China. Therefore, we plan to conduct a phase I study in pediatric solid tumors of pegylated doxorubicin combined with cyclophosphamide, vincristine, relapsed, and refractory childhood solid tumors. Maximum tolerated dose and effectiveness of stellate in children with solid tumors, thus laying the foundation for future phase II / III clinical studies

Read the detailed description

Purpose of Phase I:

the main purpose: To evaluate the safety of PLD in combination with cyclophosphamide, vincristine, regenerative, and refractory solid tumors in children, including dose absorption toxicity (DLT)

Secondary purpose:

determine the appropriate maximum tolerated dose (MTD) and /or PLD for further clinical studies in this patient population;
Describe the antitumor activity of PLD combined with cyclophosphamide and vincristine in children with advanced solid tumors or primary CNS tumors;

Exploratory purpose:

Effectiveness of PLD combined with cyclophosphamide and vincristine in treatment progress, relapse, and refractory solid tumors in children.

Conditions: Unrecognized Condition
Being tested: pegylated liposomal doxorubicin, cyclophosphamide, vincristine,

What participants receive

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

pegylated liposomal doxorubicin, cyclophosphamide, vincristine,Drug
Also called Doxorubicin Hydrochloride Liposome Injection
PLD 40mg/m2 ; PLD 50mg/m2 ; PLD 60mg/m2 ; Maximum tolerated dose； Dose-limiting toxicity

Study groups in NCT04213612
Study group	Role	What they receive
PLD+CTX+VCR	Experimental	CTX 1g/m2/d，D1-2 VCR 1.5mg/m2，D1 Receives: Drug: pegylated liposomal doxorubicin, cyclophosphamide, vincristine,

What is being measured

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

Maximum tolerated dose
Maximum tolerated dose
Measured: At the end of Cycle 1 (each cycle is 21 days)

Secondary outcomes (2)

Adverse event
Hematological and non-hematological toxicity (NCI CTCAE v5.0)
Measured: through study completion, an average of 1 year
Objective Response Rate
Complete remission + partial remission
Measured: At the end of Cycle 2 (each cycle is 21 days)

Timeline

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

30 Dec 201930 Nov 2020

First posted30 Dec 2019
Study start30 Dec 2019 (estimated)
Primary completion30 Aug 2020 (estimated)
Study completion30 Nov 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Unrecognized ConditionStudies of the same condition, open and under way.
More trials run by Sun Yat-sen 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04213612
Sponsor's protocol ID: CV-1-19
Status last verified: Dec 2019
First submitted: 24 Dec 2019
Last updated: 30 Dec 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Singal PK, Deally CM, Weinberg LE. Subcellular effects of adriamycin in the heart: a concise review. J Mol Cell Cardiol. 1987 Aug;19(8):817-28. doi: 10.1016/s0022-2828(87)80392-9. No abstract available.
PubMed 3320376
Von Hoff DD, Layard MW, Basa P, Davis HL Jr, Von Hoff AL, Rozencweig M, Muggia FM. Risk factors for doxorubicin-induced congestive heart failure. Ann Intern Med. 1979 Nov;91(5):710-7. doi: 10.7326/0003-4819-91-5-710.
PubMed 496103
Swain SM, Whaley FS, Ewer MS. Congestive heart failure in patients treated with doxorubicin: a retrospective analysis of three trials. Cancer. 2003 Jun 1;97(11):2869-79. doi: 10.1002/cncr.11407.
PubMed 12767102
Abu Lila AS, Ishida T, Kiwada H. Recent advances in tumor vasculature targeting using liposomal drug delivery systems. Expert Opin Drug Deliv. 2009 Dec;6(12):1297-309. doi: 10.1517/17425240903289928.
PubMed 19780711
Gabizon AA. Selective tumor localization and improved therapeutic index of anthracyclines encapsulated in long-circulating liposomes. Cancer Res. 1992 Feb 15;52(4):891-6.
PubMed 1737351
Northfelt DW, Martin FJ, Working P, Volberding PA, Russell J, Newman M, Amantea MA, Kaplan LD. Doxorubicin encapsulated in liposomes containing surface-bound polyethylene glycol: pharmacokinetics, tumor localization, and safety in patients with AIDS-related Kaposi's sarcoma. J Clin Pharmacol. 1996 Jan;36(1):55-63. doi: 10.1002/j.1552-4604.1996.tb04152.x.
PubMed 8932544
O'Brien ME, Wigler N, Inbar M, Rosso R, Grischke E, Santoro A, Catane R, Kieback DG, Tomczak P, Ackland SP, Orlandi F, Mellars L, Alland L, Tendler C; CAELYX Breast Cancer Study Group. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol. 2004 Mar;15(3):440-9. doi: 10.1093/annonc/mdh097.
PubMed 14998846
Schmitt CJ, Dietrich S, Ho AD, Witzens-Harig M. Replacement of conventional doxorubicin by pegylated liposomal doxorubicin is a safe and effective alternative in the treatment of non-Hodgkin's lymphoma patients with cardiac risk factors. Ann Hematol. 2012 Mar;91(3):391-7. doi: 10.1007/s00277-011-1308-y. Epub 2011 Aug 18.
PubMed 21850390
Judson I, Radford JA, Harris M, Blay JY, van Hoesel Q, le Cesne A, van Oosterom AT, Clemons MJ, Kamby C, Hermans C, Whittaker J, Donato di Paola E, Verweij J, Nielsen S. Randomised phase II trial of pegylated liposomal doxorubicin (DOXIL/CAELYX) versus doxorubicin in the treatment of advanced or metastatic soft tissue sarcoma: a study by the EORTC Soft Tissue and Bone Sarcoma Group. Eur J Cancer. 2001 May;37(7):870-7. doi: 10.1016/s0959-8049(01)00050-8.
PubMed 11313175
Beverdam A, Meijlink F. Expression patterns of group-I aristaless-related genes during craniofacial and limb development. Mech Dev. 2001 Sep;107(1-2):163-7. doi: 10.1016/s0925-4773(01)00450-6.
PubMed 11520673
Wagner HE, Gilg M, Baer HU. [Characteristics of tumor diseases in patients with colorectal cancer]. Helv Chir Acta. 1993 Mar;59(4):701-3. German.
PubMed 8473195
Lu S, Wang J, Huang J, Sun F, Zhu J, Que Y, Li H, Guo Y, Cai R, Zhen Z, Sun X, Zhang Y. Pegylated liposomal doxorubicin combined with cyclophosphamide and vincristine in pediatric patients with relapsed/refractory solid tumor: a single-arm, open-label, phase I study. EClinicalMedicine. 2024 Jun 20;73:102701. doi: 10.1016/j.eclinm.2024.102701. eCollection 2024 Jul.
PubMed 39007065

Want to know more?

Yizhuo Zhang

02087342459

zhangyzh@sysucc.org.cn

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

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Study at a glance

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

Official title: Phase I Study of Pegylated Liposomal Doxorubicin Combined With Cyclophosphamide and Vincristine in Treatment Progress, Relapse, and Refractory Solid Tumors in Children
ClinicalTrials.gov ID: NCT04213612
Acronym / sponsor ID: CV-1-19
Conditions: Unrecognized Condition
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 21 participants (estimated)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: 30 Dec 2019 (estimated)
Primary completion: 30 Aug 2020 (estimated)
Study completion: 30 Nov 2020 (estimated)
First posted: 30 Dec 2019 (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.

Detailed description

Purpose of Phase I:

the main purpose: To evaluate the safety of PLD in combination with cyclophosphamide, vincristine, regenerative, and refractory solid tumors in children, including dose absorption toxicity (DLT)

Secondary purpose:

determine the appropriate maximum tolerated dose (MTD) and /or PLD for further clinical studies in this patient population;
Describe the antitumor activity of PLD combined with cyclophosphamide and vincristine in children with advanced solid tumors or primary CNS tumors;

Exploratory purpose:

Effectiveness of PLD combined with cyclophosphamide and vincristine in treatment progress, relapse, and refractory solid tumors in children.

Study design

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

Arm	Type	Receives
PLD+CTX+VCR	Experimental	Drug: pegylated liposomal doxorubicin, cyclophosphamide, vincristine,CTX 1g/m2/d，D1-2 VCR 1.5mg/m2，D1

Who may qualify

Ages: 1 year to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (27 listed)

1) Age: 1-18 years;
2) ECOG PS score: 0-1 points;
3) Patients with solid tumors confirmed by histopathology in children;
4) Patients who have progressed, relapsed, or are refractory after first-line treatment (there is no complete or partial response after recent treatment);
5) Must have at least one measurable lesion as defined by the RECIST standard;

Key exclusion criteria (12 listed)

1) Previous or concurrent active clinical cardiovascular disease including congenital heart disease or pericardial disease, history of heart failure, myocardial infarction, coronary heart disease, heart valve disease, cardiomyopathy, arrhythmia (including persistent atrial fibrillation, Complete left bundle branch block, frequent ventricular early); or the QT interval (QTc) after the current corrected heart rate is extended> 480 milliseconds;
2) previous severe skin diseases;
3) previous allergic asthma or severe allergic disease;
4) Poorly controlled hypertension and diabetes;
5) Have a history of other tumors, except for cured cervical cancer or skin basal cell carcinoma;

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
pegylated liposomal doxorubicin, cyclophosphamide, vincristine,Also: Doxorubicin Hydrochloride Liposome InjectionPLD 40mg/m2 ; PLD 50mg/m2 ; PLD 60mg/m2 ; Maximum tolerated dose； Dose-limiting toxicity	Drug	PLD+CTX+VCR

Primary outcome

Maximum tolerated dose
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Maximum tolerated dose

2 secondary outcomes

Adverse event
Time frame: through study completion, an average of 1 year
Objective Response Rate
Time frame: At the end of Cycle 2 (each cycle is 21 days)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
Background: PubMed 3320376Singal PK, Deally CM, Weinberg LE. Subcellular effects of adriamycin in the heart: a concise review. J Mol Cell Cardiol. 1987 Aug;19(8):817-28. doi: 10.1016/s0022-2828(87)80392-9. No abstract available.
Background: PubMed 496103Von Hoff DD, Layard MW, Basa P, Davis HL Jr, Von Hoff AL, Rozencweig M, Muggia FM. Risk factors for doxorubicin-induced congestive heart failure. Ann Intern Med. 1979 Nov;91(5):710-7. doi: 10.7326/0003-4819-91-5-710.
Background: PubMed 12767102Swain SM, Whaley FS, Ewer MS. Congestive heart failure in patients treated with doxorubicin: a retrospective analysis of three trials. Cancer. 2003 Jun 1;97(11):2869-79. doi: 10.1002/cncr.11407.
Background: PubMed 19780711Abu Lila AS, Ishida T, Kiwada H. Recent advances in tumor vasculature targeting using liposomal drug delivery systems. Expert Opin Drug Deliv. 2009 Dec;6(12):1297-309. doi: 10.1517/17425240903289928.
Background: PubMed 1737351Gabizon AA. Selective tumor localization and improved therapeutic index of anthracyclines encapsulated in long-circulating liposomes. Cancer Res. 1992 Feb 15;52(4):891-6.
Background: PubMed 8932544Northfelt DW, Martin FJ, Working P, Volberding PA, Russell J, Newman M, Amantea MA, Kaplan LD. Doxorubicin encapsulated in liposomes containing surface-bound polyethylene glycol: pharmacokinetics, tumor localization, and safety in patients with AIDS-related Kaposi's sarcoma. J Clin Pharmacol. 1996 Jan;36(1):55-63. doi: 10.1002/j.1552-4604.1996.tb04152.x.
Background: PubMed 14998846O'Brien ME, Wigler N, Inbar M, Rosso R, Grischke E, Santoro A, Catane R, Kieback DG, Tomczak P, Ackland SP, Orlandi F, Mellars L, Alland L, Tendler C; CAELYX Breast Cancer Study Group. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol. 2004 Mar;15(3):440-9. doi: 10.1093/annonc/mdh097.
Background: PubMed 21850390Schmitt CJ, Dietrich S, Ho AD, Witzens-Harig M. Replacement of conventional doxorubicin by pegylated liposomal doxorubicin is a safe and effective alternative in the treatment of non-Hodgkin's lymphoma patients with cardiac risk factors. Ann Hematol. 2012 Mar;91(3):391-7. doi: 10.1007/s00277-011-1308-y. Epub 2011 Aug 18.
Background: PubMed 11313175Judson I, Radford JA, Harris M, Blay JY, van Hoesel Q, le Cesne A, van Oosterom AT, Clemons MJ, Kamby C, Hermans C, Whittaker J, Donato di Paola E, Verweij J, Nielsen S. Randomised phase II trial of pegylated liposomal doxorubicin (DOXIL/CAELYX) versus doxorubicin in the treatment of advanced or metastatic soft tissue sarcoma: a study by the EORTC Soft Tissue and Bone Sarcoma Group. Eur J Cancer. 2001 May;37(7):870-7. doi: 10.1016/s0959-8049(01)00050-8.
Background: PubMed 11520673Beverdam A, Meijlink F. Expression patterns of group-I aristaless-related genes during craniofacial and limb development. Mech Dev. 2001 Sep;107(1-2):163-7. doi: 10.1016/s0925-4773(01)00450-6.
Background: PubMed 8473195Wagner HE, Gilg M, Baer HU. [Characteristics of tumor diseases in patients with colorectal cancer]. Helv Chir Acta. 1993 Mar;59(4):701-3. German.
Derived from this study: PubMed 39007065Lu S, Wang J, Huang J, Sun F, Zhu J, Que Y, Li H, Guo Y, Cai R, Zhen Z, Sun X, Zhang Y. Pegylated liposomal doxorubicin combined with cyclophosphamide and vincristine in pediatric patients with relapsed/refractory solid tumor: a single-arm, open-label, phase I study. EClinicalMedicine. 2024 Jun 20;73:102701. doi: 10.1016/j.eclinm.2024.102701. eCollection 2024 Jul.
Singal, P.K., C.M. Deally and L.E. Weinberg, Subcellular effects of adriamycin in the heart: a concise review. J Mol Cell Cardiol, 1987. 19(8): p. 817-28.Link provided by the sponsor.
Von Hoff, D.D., et al., Risk factors for doxorubicin-induced congestive heart failure. Ann Intern Med, 1979. 91(5): p. 710-7Link provided by the sponsor.
Swain, S.M., F.S. Whaley and M.S. Ewer, Congestive heart failure in patients treated with doxorubicin: a retrospective analysis of three trials. Cancer, 2003. 97(11): p. 2869-79Link provided by the sponsor.
Abu A L, Ishida T, Kiwada H. Recent advances in tumor vasculature targeting using liposomal drug delivery systems.\[J\]. Expert Opinion on Drug Delivery, 2009, 6(12):1297.Link provided by the sponsor.
Gabizon AA. Selective tumor localization and improved therapeutic index of anthracyclines encapsulated in long-circulating liposomes\[J\]. Cancer Research, 1992, 52(4):891-896.Link provided by the sponsor.
Northfelt D W, Martin F J, Working P, et al. Doxorubicin Encapsulated in Liposomes Containing Surface-Bound Polyethylene Glycol: Pharmacokinetics, Tumor Localization, and Safety in PatientsLink provided by the sponsor.

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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.

Yizhuo Zhang contact

02087342459

zhangyzh@sysucc.org.cn

Yizhuo Zhang principal investigator

Sun Yat-sen University CancerCenter

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing pegylated liposomal doxorubicin, cyclophosphamide, vincristine, in people with Unrecognized Condition, run by Sun Yat-sen University.

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 27 inclusion and 12 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 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

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 Yizhuo Zhang (02087342459, zhangyzh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (time frame: At the end of Cycle 1 (each cycle is 21 days)). 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 NCT04213612, which also lists 12 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 30 Dec 2019.