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Pancreas CancerPhase 2RESOUNDNCT02307500

Regorafenib in Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy

A Phase 2 study testing Regorafenib in people with Pancreas Cancer and Ovarian Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.

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

This is a single arm, single-stage, phase II trial to evaluate the activity of Regorafenib in patients with metastatic solid tumors (pancreatic cancer, ovarian cancer, melanoma, sarcoma, thymoma (type B2 - B3) and thymic carcinoma, who have progressed after standard therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreas Cancer, Ovarian Cancer, Melanoma
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
82 participants
Where
1 siteItaly
Study dates
Dec 2014to Aug 2020
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Patients older then 18 years.
  • Locally advanced, recurrent or metastatic histologically confirmed malignancy refractory to available standard treatment, included Pancreatic cancer, Ovarian cancer, Melanoma, Sarcoma
  • At least one measurable lesion according to Response Evaluation Criteria In solid tumor
  • Eastern Cooperative Oncology Group Performance Status: 0-1
  • Life expectancy of at least 12 weeks
Show all 11Show fewer
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory : Hemoglobin > 9.0 g/dl Absolute neutrophil count > 1,500/mm3 Platelet count > 100,000/μl White blood cells >3.0 x 109/L Total bilirubin <1.5 times the upper limit of normal Alanine amino transferase and aspartate amino transferase <2.5 x upper limit of normal (<5 x upper limit of normal for patients with liver involvement) Serum creatinine <1.5 x upper limit of normal Alkaline phosphatase <2.5 x Upper Limit of Normal Prothrombin time / Partial prothrombin time <1.5 x Upper Limit of Normal Lipase ≤ 1.5 x the Upper Limit of Normal
  • Able to swallow and retain oral medication.
  • Estimated creatinine clearance > 30ml/min as calculated using the Cockcroft-Gault equation
  • Resolution of any toxic effects of prior therapy to NCI Common Terminology Criteria for Adverse Event, Version 4.0, grade ≤ 1 .
  • Women of childbearing potential and men must agree to use adequate contraception

Who cannot join

  • Prior treatment with regorafenib.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug
  • Congestive heart failure >New York Heart Association class 2
  • Unstable angina), new-onset angina.Myocardial infarction less than 6 months before start of study drug
  • Myocardial infarction less than 6 months before start of study drug.
  • Cardiac arrhythmias requiring anti-arrhythmic therapy
Show all 27Show fewer
  • Uncontrolled hypertension.
  • Pleural effusion or ascites that causes respiratory compromise
  • Ongoing infection > Grade 2
  • Known history of human immunodeficiency virus infection.
  • Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy.
  • Subjects with seizure disorder requiring medication.
  • History of organ allograft. Subjects with evidence or history of any bleeding diathesis, irrespective of severity.
  • Any hemorrhage or bleeding event > Common Toxicity Criteria for Adverse Effects Grade 3
  • Arterial or venous thrombotic or embolic events within the 6 months before start of study medication
  • Known history or symptomatic metastatic brain or meningeal tumors
  • Suggestive or consistent with central nervous system disease
  • Renal failure requiring hemo-or peritoneal dialysis.
  • Dehydration Common Toxicity Criteria for Adverse Effects v. 4.0 Grade >1.
  • Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.
  • Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
  • Any illness or medical conditions that are unstable or could jeopardize the safety of the subject and his/her compliance in the study.
  • Interstitial lung disease with ongoing signs and symptoms
  • Persistent proteinuria of CTCAE Grade 3
  • Any malabsorption condition.
  • Concomitant participation or participation within the last 30 days in another clinical trial
  • Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 weeks before starting to receive study medication.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Istituto Clinico Humanitas

    Rozzano, Milan, 20089

Other trials in Italy

About this study

Official title: An Open-label Phase II Study of Regorafenib in Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy - RESOUND

This is a single arm, single-stage, phase II trial to evaluate the activity of Regorafenib in patients with metastatic solid tumors (pancreatic cancer, ovarian cancer, melanoma, sarcoma, thymoma (type B2 - B3) and thymic carcinoma, who have progressed after standard therapy.

Read the detailed description

Each tumour will be assessed by itself. Regorafenib 40 mg tablets will be used in the study. Subjects will receive 160 mg regorafenib po every day (qd) for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off).

Subjects will continue on treatment until at least one of the following occurs (main criteria):

  • Progressive Disease (PD) by radiological assessments or clinical progression
  • Death
  • Unacceptable toxicity
  • Subject withdraws consent
  • Treating physician determines discontinuation of treatment is in the subject's best interest
  • Substantial non-compliance with the protocol
Being tested
Regorafenib
Medical subject headings
Pancreatic Neoplasms, Ovarian Neoplasms, Melanoma, Sarcoma, Thymoma

What participants receive

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

Study groups in NCT02307500
Study groupRoleWhat they receive
RegorafenibExperimentalRegorafenib 160 mg (40 mg tablets), po, every day for 3 weeks of every 4 week cycle
Receives: Drug: Regorafenib

What is being measured

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

  1. activity of regorafenib screening, in terms of 2-months progression free survival rate

    to evaluate activity of regorafenib, in terms of 2-months progression free survival rate

    Measured: 2 months

Secondary outcomes (3)

  1. prognosis in terms of progression-free survival

    to explore the prognosis in terms of progression-free survival calculated from the first day of regorafenib treatment to the date of tumor progression or death, whichever occurs first.

    Measured: 36 months

  2. overall survival (OS)

    to explore overall survival (OS) measured from the first day of regorafenib treatment until the date of death from any cause or the date of the last contact, at which the patients will be censored

    Measured: 36 months

  3. safety profile of regorafenib according to NCI-CTC v.3

    to assess the safety profile of regorafenib according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3

    Measured: 3 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 Dec 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionDec 2017
  4. Study completionAug 2020

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
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02307500
Sponsor's protocol ID
ONC-2014-001
Acronym
RESOUND
Status last verified
Sep 2022
First submitted
25 Nov 2014
Last updated
10 Sep 2022
Results posted
No
Data monitoring committee
No

Publications

  • Wilhelm SM, Dumas J, Adnane L, Lynch M, Carter CA, Schutz G, Thierauch KH, Zopf D. Regorafenib (BAY 73-4506): a new oral multikinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases with potent preclinical antitumor activity. Int J Cancer. 2011 Jul 1;129(1):245-55. doi: 10.1002/ijc.25864. Epub 2011 Apr 22.

    PubMed 21170960

  • Carmeliet P, Jain RK. Angiogenesis in cancer and other diseases. Nature. 2000 Sep 14;407(6801):249-57. doi: 10.1038/35025220.

    PubMed 11001068

  • Ferrara N. Vascular endothelial growth factor as a target for anticancer therapy. Oncologist. 2004;9 Suppl 1:2-10. doi: 10.1634/theoncologist.9-suppl_1-2.

    PubMed 15178810

  • Fong GH, Rossant J, Gertsenstein M, Breitman ML. Role of the Flt-1 receptor tyrosine kinase in regulating the assembly of vascular endothelium. Nature. 1995 Jul 6;376(6535):66-70. doi: 10.1038/376066a0.

    PubMed 7596436

  • Shalaby F, Rossant J, Yamaguchi TP, Gertsenstein M, Wu XF, Breitman ML, Schuh AC. Failure of blood-island formation and vasculogenesis in Flk-1-deficient mice. Nature. 1995 Jul 6;376(6535):62-6. doi: 10.1038/376062a0.

    PubMed 7596435

  • Goodman VL, Rock EP, Dagher R, Ramchandani RP, Abraham S, Gobburu JV, Booth BP, Verbois SL, Morse DE, Liang CY, Chidambaram N, Jiang JX, Tang S, Mahjoob K, Justice R, Pazdur R. Approval summary: sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinoma. Clin Cancer Res. 2007 Mar 1;13(5):1367-73. doi: 10.1158/1078-0432.CCR-06-2328.

    PubMed 17332278

  • Amit L, Ben-Aharon I, Vidal L, Leibovici L, Stemmer S. The impact of Bevacizumab (Avastin) on survival in metastatic solid tumors--a meta-analysis and systematic review. PLoS One. 2013;8(1):e51780. doi: 10.1371/journal.pone.0051780. Epub 2013 Jan 22.

    PubMed 23349675

  • Yancopoulos GD, Davis S, Gale NW, Rudge JS, Wiegand SJ, Holash J. Vascular-specific growth factors and blood vessel formation. Nature. 2000 Sep 14;407(6801):242-8. doi: 10.1038/35025215.

    PubMed 11001067

  • Acevedo VD, Ittmann M, Spencer DM. Paths of FGFR-driven tumorigenesis. Cell Cycle. 2009 Feb 15;8(4):580-8. doi: 10.4161/cc.8.4.7657. Epub 2009 Feb 18.

    PubMed 19182515

  • Bergers G, Song S, Meyer-Morse N, Bergsland E, Hanahan D. Benefits of targeting both pericytes and endothelial cells in the tumor vasculature with kinase inhibitors. J Clin Invest. 2003 May;111(9):1287-95. doi: 10.1172/JCI17929.

    PubMed 12727920

  • Augustin HG, Koh GY, Thurston G, Alitalo K. Control of vascular morphogenesis and homeostasis through the angiopoietin-Tie system. Nat Rev Mol Cell Biol. 2009 Mar;10(3):165-77. doi: 10.1038/nrm2639.

    PubMed 19234476

  • Huang J, Bae JO, Tsai JP, Kadenhe-Chiweshe A, Papa J, Lee A, Zeng S, Kornfeld ZN, Ullner P, Zaghloul N, Ioffe E, Nandor S, Burova E, Holash J, Thurston G, Rudge J, Yancopoulos GD, Yamashiro DJ, Kandel JJ. Angiopoietin-1/Tie-2 activation contributes to vascular survival and tumor growth during VEGF blockade. Int J Oncol. 2009 Jan;34(1):79-87.

    PubMed 19082480

  • Bach F, Uddin FJ, Burke D. Angiopoietins in malignancy. Eur J Surg Oncol. 2007 Feb;33(1):7-15. doi: 10.1016/j.ejso.2006.07.015. Epub 2006 Sep 7.

    PubMed 16962282

  • Saito M, Watanabe J, Fujisawa T, Kamata Y, Nishimura Y, Arai T, Miyamoto T, Obokata A, Kuramoto H. Angiopoietin-1, 2 and Tie2 expressions in endometrial adenocarcinoma--the Ang2 dominant balance up-regulates tumor angiogenesis in the presence of VEGF. Eur J Gynaecol Oncol. 2006;27(2):129-34.

    PubMed 16620053

  • Szarvas T, Jager T, Totsch M, vom Dorp F, Kempkensteffen C, Kovalszky I, Romics I, Ergun S, Rubben H. Angiogenic switch of angiopietins-Tie2 system and its prognostic value in bladder cancer. Clin Cancer Res. 2008 Dec 15;14(24):8253-62. doi: 10.1158/1078-0432.CCR-08-0677.

    PubMed 19088043

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Regorafenib in people with Pancreas Cancer and Ovarian Cancer, run by Istituto Clinico Humanitas at 1 site 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 11 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: finished, as of the sponsor's last update on 10 Sep 2022. 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 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?

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?

activity of regorafenib screening, in terms of 2-months progression free survival rate (time frame: 2 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 NCT02307500, which also lists 29 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 10 Sep 2022.

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