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Advanced Colorectal CancerPhase 2STREAMNCT02619435

Regorafenib Monotherapy as Second-line Treatment of Patients With RAS-mutant Advanced Colorectal Cancer

A Phase 2 study testing regorafenib in people with Advanced Colorectal Cancer, run by National Cancer Institute, Naples at 4 sites in Italy.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to purpose of this study is to assess if regorafenib is active enough, in terms of 6-month progression-free rate, to warrant further comparative studies in patients with RAS-mutant advanced colorectal cancer who have progressed after first-line oxaliplatin-based chemotherapy plus… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Colorectal Cancer
What is being tested?
regorafenib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
4 sitesItaly
Study dates
Nov 2015to Nov 2024
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

  • Histologically confirmed diagnosis of colorectal adenocarcinoma
  • Any RAS mutation that prevent treatment with anti-EGFR antibodies
  • Stage IV
  • Measurable disease according to RECIST v. 1.1
  • Disease progression during or following a treatment with fluoropyrimidine, oxaliplatin and bevacizumab, and a treatment with irinotecan is not considered immediately mandatory by the Investigator
  • Age ≥ 18 years
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  • ECOG Performance Status 0-1
  • Neutrophils > 1500 / mm3, platelets > 100,000 / mm3, and hemoglobin > 9 g/dL without transfusion or granulocyte-colony stimulating factor (G-CSF) and other hematopoietic growth factors.
  • Bilirubin level < 1.5 x ULN
  • Glomerular filtration rate > 30 mL/min/1.73 m2 according to the Modified Diet in Renal Disease abbreviated formula
  • AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN (≤ 5 x ULN if liver metastasis are present)
  • Alkaline phosphatase ≤ 2.5 x ULN (≤ 5 x ULN if liver metastasis are present)
  • Serum creatinine < 1.5 x ULN
  • Amylase and lipase ≤ 1.5 x ULN
  • INR and aPTT ≤ 1.5 x ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no underlying abnormality in coagulation parameters exists per medical history.
  • Understand, be willing to give consent, and sign the written informed consent form (ICF) prior to undergoing any study-specific procedure.
  • If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment.
  • If potentially childbearing female, or if male, agree to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method) from the date on which the ICF is signed until 8 weeks after the last dose of study drug.
  • Life expectancy of greater than 3 months

Who cannot join

  • Previous treatment with regorafenib or irinotecan
  • Are taking strong cytochrome P (CYP) CYP3A4 inhibitors (eg, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole) or strong CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort)
  • Have had a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment
  • Have congestive heart failure classified as New York Heart Association Class 2 or higher
  • Have had unstable angina (angina symptoms at rest) or new-onset angina < 3 months prior to screening.
  • Have had a myocardial infarction < 6 months prior to initiation of study treatment.
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  • Have cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin.
  • Have had arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months prior to the initiation of study treatment
  • Symptomatic brain metastases or meningeal tumors
  • Patients with evidence or history of bleeding diathesis
  • Uncontrolled hypertension (systolic blood pressure [SBP] >140 mmHg or diastolic blood pressure [DBP] > 90 mmHg)
  • Have interstitial lung disease with ongoing signs and symptoms at the time informed consent is obtained
  • Have persistent proteinuria > 3.5 g/24 hours measured by urine protein creatinine ratio from a random urine sample (< Grade 3, CTCAE v 4.0).
  • Have unresolved toxicity higher than National Cancer Institute-Common Terminology for Adverse Events version 4.0 (CTCAE v 4.0) Grade 1 attributed to any prior therapy/procedure, excluding alopecia and/or oxaliplatin-induced neurotoxicity ≤ Grade 2 and hemoglobin ≥ 9 g/dL as per inclusion criteria
  • Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease
  • Pregnant or lactating women
  • Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)
  • Any unstable systemic disease (including active infections, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of regorafenib or render the patient at high risk for treatment complications
  • Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
  • Have any other serious or unstable illness, or medical, psychological, or social condition, that could jeopardize the safety of the subject and/or his/her compliance with study procedures, or may interfere with the subject's participation in the study or evaluation of the study results.
  • Have a known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs.
  • Have a close affiliation with the investigational site (eg, be a close relative of the investigator) or be a dependent person (eg, be an employee or student working at the investigational site).

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

  • AO G. Rummo

    Benevento

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples

  • Seconda Università di Napoli

    Naples

  • AO S. Carlo

    Potenza

Other trials in Italy

About this study

Official title: Regorafenib Monotherapy as Second-line Treatment of Patients With RAS-mutant Advanced Colorectal Cancer: a Multicentre, Single-arm, Two-stage, Phase 2 Study

The purpose of this study is to purpose of this study is to assess if regorafenib is active enough, in terms of 6-month progression-free rate, to warrant further comparative studies in patients with RAS-mutant advanced colorectal cancer who have progressed after first-line oxaliplatin-based chemotherapy plus bevacizumab.

Being tested
regorafenib
Keywords
RAS-mutant

What participants receive

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

  • regorafenibDrug

    Patients will receive regorafenib orally 160 mg once daily for the first 3 weeks of each 4-week cycle.

Study groups in NCT02619435
Study groupRoleWhat they receive
regorafenibExperimentalNot described
Receives: Drug: regorafenib

What is being measured

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

  1. the rate of evaluable patients alive and not progressed at 6 months

    Measured: 6 months

Secondary outcomes (4)

  1. worst grade toxicity per patient

    evaluated according to RECIST 1.1

    Measured: every 4 weeks up to 1 year

  2. number of patients with complete plus partial response

    Measured: 6 months

  3. progression free survival

    the time from registration to progression or death without progression

    Measured: up to one year

  4. overall survival

    as the time from registration to the date of death due to any cause

    Measured: up to 2 years

Timeline

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

  1. First posted2 Dec 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionNov 2024 (estimated)
  4. Study completionNov 2024 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02619435
Sponsor's protocol ID
STREAM
Other IDs
2015-001105-13, 2015
Acronym
STREAM
Status last verified
Mar 2023
First submitted
30 Nov 2015
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing regorafenib in people with Advanced Colorectal Cancer, run by National Cancer Institute, Naples at 4 sites in Italy.

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 19 inclusion and 22 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 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. 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?

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?

the rate of evaluable patients alive and not progressed at 6 months (time frame: 6 months). 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 NCT02619435.

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 2023.

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