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Colo-rectal CancerPhase 1/2NCT03545711

Safety and Efficacy of Anlotinib in Combination With Irinotecan in Patients With Pretreated Advanced Colorectal Cancer

A Phase 1/2 study testing Anlotinib Hydrochloride with Irinotecan in people with Colo-rectal Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Patients with pretreated advanced colorectal cancer are recruited to the phase I portion of this prospective non-randomised study in an escalated dose cohort. The primary endpoint of the dose-escalation phase is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of anlotinib when given… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Colo-rectal Cancer
What is being tested?
Anlotinib Hydrochloride with Irinotecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteChina
Study dates
26 May 2018to 24 Nov 2020
Phase
Phase 1/2
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

  • Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
  • willing and able to provide written informed consent and comply with the requirements of the study
  • histologically- or cytologically-confirmed advanced colorectal cancer
  • failed or intolerable to at least one prior therapy
  • have evidence of measurable disease per RECIST v1.1
  • Eastern Collaborative Oncology Group (ECOG) Performance Status ≤ 1
  • weight ≥40kg
  • life expectancy >12 weeks

Who cannot join

  • Subjects meeting any of the following criteria are ineligible for participation in the study:
  • history of any anti-cancer therapy (including investigational agents) within 28 days prior to study entry
  • presence of toxicity of prior anti-cancer therapy that has not resolved to Grade 1, as determined by National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03
  • symptomatic brain metastasis requiring active treatment
  • any previous malignancy, except for non squamous-cell carcinoma of skin or carcinoma-in-situ of the uterine cervix within 5 years prior to study entry
  • active or clinically unstable infection requiring systemic therapy
Show all 27Show fewer
  • unable to swallow oral medications or with gastrointestinal disorders that might interfere with proper absorption of oral drugs
  • active digestive ulcer disease, inflammatory bowel disease, intestinal obstruction or any other condition that, in the clinical judgment of the Principal Investigator, may cause severe gastrointestinal bleeding or perforation
  • unstable pulmonary embolism, deep vein thrombosis, or other significant arterial/venous thromboembolic event ≤2 months prior to study entry
  • history of stroke or transient ischemic attack (TIA) within 12 months prior to study entry
  • any of the following abnormal findings in organ or marrow function 1 week prior to study entry:
  • Leukocytes < 1.5*10^9/L, or Platelets < 100*10^9/L, or Hb< 90g/L
  • Total bilirubin > 1.5 × institutional upper limit of normal (ULN), or AST (aspartate amino transferase)/ALT (alanine amino transferase)> 3 × institutional ULN for liver metastases, > 1.5 × institutional ULN in case of no liver metastases
  • any electrolyte imbalance of clinical significance
  • creatinine > institutional ULN and creatinine clearance < 60 mL/min
  • spot urine protein ≥(2+) or 24-hour proteinuria ≥1.0g/24h
  • APTT (activated partial thromboplastin time) or INR (international normalized ratio for prothrombin time) > 1.5 × institutional ULN
  • treatment refractory hypertension defined as a blood pressure of systolic> 140 millimeter of mercury (mm Hg) and/or diastolic > 90 mm Hg which cannot be controlled by a single anti-hypertensive agent
  • LVEF (left ventricular ejection fraction ) <50%
  • history of acute coronary syndromes (including myocardial infarction and unstable angina), coronary artery bypass graft within 6 months prior to study entry, or history or evidence of current ≥ Class II congestive heart failure as defined by New York Heart Association (NYHA)
  • present with non-healing fractures of bone or wounds of skin
  • pregnant or lactating female
  • sexually active female (of childbearing potential) or male unwilling to adopt an effective method of birth control during the course of the study
  • serious and/or unstable pre-existing psychiatric disorder
  • familial, sociological or geographical conditions that, in the clinical judgment of the Principal Investigator, do not permit compliance with the protocol
  • known immediate or delayed hypersensitivity reaction to anlotinib, irinotecan or their excipients
  • administration of irinotecan in prior treatments

Trial locations and contacts

1 site in 1 country.

Jing Huang, MD contact

86-10-87788102

huangjingwg@163.com

Yan Song, M.D contact

China1 site, 1 recruiting

  • Jing Huang

    Beijing, 100021

    Jing Huang, MD

    Recruiting

Other trials in China

About this study

Official title: Safety and Efficacy of Irinotecan Combined With Anlotinib in Patients With Pretreated Advanced Colorectal Cancer

Patients with pretreated advanced colorectal cancer are recruited to the phase I portion of this prospective non-randomised study in an escalated dose cohort. The primary endpoint of the dose-escalation phase is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of anlotinib when given in combination with irinotecan. The phase II (dose-expansion) portion is designed to characterize the safety and potential efficacy of the combination therapy in pretreated advanced colorectal cancer patients.

Being tested
Anlotinib Hydrochloride with Irinotecan
Medical subject headings
Colonic Neoplasms

What participants receive

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

  • Anlotinib Hydrochloride with IrinotecanDrug

    Dose escalation of anlotinib starts from 8mg qd d1-14/q21d in combination with fixed dose of irinotecan at 180mg/m2 d1/q14d.

Study groups in NCT03545711
Study groupRoleWhat they receive
Anlotinib plus IrinotecanExperimentalNot described
Receives: Drug: Anlotinib Hydrochloride with Irinotecan

What is being measured

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

  1. MTD

    the maximum tolerated dose (MTD) of Anlotinib when administered in combination with fixed dose of irinotecan in advanced colorectal cancer patients.

    Measured: 6 months

  2. ORR

    the overall response rate (ORR) of Anlotinib when administered in combination with fixed dose of irinotecan in advanced colorectal cancer patients.

    Measured: 18 months

Secondary outcomes (2)

  1. DCR

    the disease control rate (DCR) of the combination of Anlotinib with Irinotecan in pretreated advanced colorectal cancer patients.

    Measured: 18 months

  2. PFS

    the progression free survival (PFS) of the combination of Anlotinib with Irinotecan in pretreated advanced colorectal cancer patients.

    Measured: 18 months

Timeline

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

  1. First posted4 Jun 2018
  2. Study start26 May 2018
  3. Primary completion24 Nov 2019 (estimated)
  4. Study completion24 Nov 2020 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03545711
Sponsor's protocol ID
NCC201803012
Status last verified
Aug 2018
First submitted
23 May 2018
Last updated
6 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Anlotinib Hydrochloride with Irinotecan in people with Colo-rectal Cancer, run by Chinese Academy of Medical Sciences 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 8 inclusion and 27 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 6 Aug 2018. 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 combined 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.

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 Jing Huang, MD (86-10-87788102, huangjingwg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT03545711.

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 6 Aug 2018.

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