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Advanced Solid TumorPhase 1NCT01832298

Study of Simmitecan Hydrochloride in the Treatment of Advanced Solid Tumor

A Phase 1 study testing Simmitecan Hydrochloride for Injection in people with Advanced Solid Tumor, run by Haihe Biopharma Co., Ltd. at 3 sites 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

RATIONAL: Simmitecan is an anticancer ester prodrug, which involves activation to chimmitecan. Chimmitecan，a novel CPT derivative, exhibited potent antitumor activities both in vitro and in vivo by inhibiting topoisomerase I. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
Simmitecan Hydrochloride for Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
3 sitesChina
Study dates
Dec 2012to Aug 2016
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Relapsed or refractory to standard therapy or no standard therapy available.
  • At least one measurable lesion.
  • Age = 18~65 years.
  • ECOG=0-1.
  • Life expectancy ≥ 12 weeks.
  • More than 4 weeks after operation, chemotherapy, radiotherapy, cytotoxic agents or tyrosine kinase inhibitors.
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  • Adequate organ function:
  • Haemoglobin ≥ 100 g/L, Absolute neutrophil count [ANC] ≥ 2×109/L,Platelets ≥ 100 × 109/L), Serum bilirubin ≤ 1.0×ULN, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 1.5×ULN (If liver metastases, serum transaminase ≤ 2.5×ULN), Creatinine clearance ≥ 50 mL/min , LVEF ≤ 50%, QT interval (corrected by Fridericia): male < 450 ms, female < 470 ms
  • Female: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article. Child bearing potential, a negative urine or serum pregnancy test result before initiating Famitinib. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article.
  • Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Who cannot join

  • Less than 4 weeks from the last clinical trial.
  • Known Spinal Cord compression or diseases of brain or pia mater by CT /MRI screening.
  • Patients had ever severe diarrhea with prior therapy of camptothecin drugs.
  • Concurrent severe or uncontrolled medical disease (serious infection, serious diabetes)
  • Significant cardiovascular disease or condition including ≥ class II cardiac function (NYHA)
  • Acute and chronic viral hepatitis. (If HBsAg +, HBV-DNA quantification ≤ LLN.)
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  • Pregnant, lactation period or men/women ready to birth.
  • Psychiatric disorder or altered mental status.
  • Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610000

  • The tumor hospital affiliated to Harbin medical university

    Harbin, Heilongjiang, 150000

Other trials in China

About this study

Official title: Phase I Study of Simmitecan Hydrochloride for Injection in Patients With Advanced Solid Tumor：Tolerability and Pharmacokinetics

RATIONAL: Simmitecan is an anticancer ester prodrug, which involves activation to chimmitecan. Chimmitecan，a novel CPT derivative, exhibited potent antitumor activities both in vitro and in vivo by inhibiting topoisomerase I. Also exerted comparable effects on topoisomerase I compared with topotecan and SN38 and possessed improved anticancer potency and pharmacologic profiles, compared with the clinically available CPT analogues.

PURPOSE: to determine the maximum tolerated dose, the safety profile and pharmacokinetics of Simmitecan.

Being tested
Simmitecan Hydrochloride for Injection
Keywords
Tolerability, Pharmacokinetics

What participants receive

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

  • Simmitecan Hydrochloride for InjectionDrug

    Either at 12.5 mg, 25 mg、50 mg、80 mg、120 mg、160 mg、200 mg

Study groups in NCT01832298
Study groupRoleWhat they receive
Simmitecan Hydrochloride for InjectionExperimentalDissolving in 2ml water for injection, then transfering to 500 mL of 5% dextrose for i.v.90 minutes
Receives: Drug: Simmitecan Hydrochloride for Injection

What is being measured

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

  1. Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)

    To evaluate the DLT and MTD in patients with advanced solid tumor

    Measured: 2 weeks

Secondary outcomes (3)

  1. Pharmacokinetic Assessment

    To investigate pharmacokinetics of Simmitecan and Chimmitecan:AUC,Cmax,T1/2, CL/F.

    Measured: 1-4 days

  2. Efficacy Assessments

    Objective Response Rate (ORR), Disease Control Rate(DCR)

    Measured: 0-6 weeks

  3. Pharmacodynamic Assessments

    Evaluate the genotyping of UGT1A1*6 and UGT1A1*28.

    Measured: 0 days

Timeline

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

  1. First posted16 Apr 2013 (estimated)
  2. Study startDec 2012
  3. Primary completionMar 2016
  4. Study completionAug 2016

Resources

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
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01832298
Sponsor's protocol ID
LP-101
Status last verified
Oct 2016
First submitted
8 Apr 2013
Last updated
20 Dec 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Simmitecan Hydrochloride for Injection in people with Advanced Solid Tumor, run by Haihe Biopharma Co., Ltd. at 3 sites 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 10 inclusion and 9 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 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) (time frame: 2 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 NCT01832298.

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 20 Dec 2016; AzTrials last refreshed its copy on 8 Nov 2026.

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