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Tumor Pathway Activations Inhibited by DovitinibPhase 2SIGNATURENCT01831726

Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib

A Phase 2 study testing Dovitinib (TKI258) in people with Tumor Pathway Activations Inhibited by Dovitinib, run by Novartis Pharmaceuticals at 49 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this signal seeking study was to determine whether treatment with dovitinib (TKI258) demonstrated sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study. Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Dovitinib (TKI258)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
49 sitesUnited States
Study dates
Aug 2013to Dec 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients eligible for inclusion in this study had to meet all of the following criteria:
  • Patient's age was ≥ 18 years of age at the time of signing informed consent.
  • Patient had a confirmed diagnosis of a selected solid tumor (except for primary diagnosis of urothelial tumors, hepatocellular carcinoma (HCC), endometrial carcinoma, metastatic breast cancer (mBC), squamous NSCLC, and renal cell carcinoma (RCC)) or hematologic malignancies (except for primary diagnosis of FLT3 AML and multiple myeloma). Additional tumor types could be excluded during the course of the study in the case of early futility or success based upon an interim analysis or at the discretion of Novartis.
  • Patient was in need of treatment because of progression or relapse defined as:
  • radiological progression for solid tumor and lymphoma
  • for hematologic malignancies, measureable progression or relapse by appropriate criteria
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  • Patients had pre-identified tumor with a mutation and/or translocation of one of the known kinase targets of dovitinib. The qualifying alteration were assessed and reported by a CLIA-certified laboratory. The mutations included:
  • FGFR 1-3 (amplifications were also allowed)
  • PDGFRα or PDGFRβ
  • VEGFR1-2 (KDR)
  • FLT3, cKIT (amplifications are also allowed),
  • RET, TrkA (NTRK1), or CSF-1R
  • Patient had archival tissue available for submission to allow for molecular testing related to pathway activation. If the tissue was not available or not of sufficient quantity the patient was willing to undergo a fresh tumor biopsy to allow for this analysis. The sample was submitted prior to first study dose unless agreed upon between Novartis and the investigator.
  • Patient received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options were anticipated to result in a durable remission.
  • Diffuse large B cell lymphoma only: Patient received or was ineligible for autologous or allogeneic stem cell transplant. This did not apply to patients with Mantle cell lymphoma or follicular lymphoma
  • Patients with measurable disease as per appropriate guidelines:
  • Solid Tumors: by RECIST 1.1
  • Lymphoma: Patient had at least one measurable nodal lesion (≥2 cm) according to Cheson criteria (Cheson 2007). In case where the patient had no measurable nodal lesions ≥ 2 cm in the long axis at screening, then the patient had at least one measurable extra-nodal lesion.
  • Leukemia only: Relapsed/refractory leukemia for which no standard therapy options were anticipated to result in a durable remission:
  • Acute myelogenous leukemia (AML) by World Health Organization (WHO) classification (except FLT3) or acute lymphoblastic leukemia (ALL) relapsed or refractory to standard chemotherapy; unsuitable for standard chemotherapy or unwilling to undergo standard chemotherapy. Philadelphia chromosome (Ph) positive ALL eligible if failed prior tyrosine-kinase inhibitor therapy.
  • Age > 60 years with AML (except FLT3) not candidates for or have refused standard chemotherapy, excluding patients with acute promyelocytic leukemia (APL) or with favorable cytogenetic abnormalities.
  • For patients with Chronic Myeloid Leukemia (CML) only accelerated and blast phase CML were allowed.
  • Patient with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  • Patient with a life expectancy of at least 16 weeks
  • All Patients were having adequate bone marrow as described below:
  • Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L (not applicable for leukemia patients).
  • Platelets (PLT) ≥ 75 x 109/L (no platelet transfusion within past 14 days) (not applicable for leukemia patients).
  • Hemoglobin (Hgb) ≥ 9 g/dl (not applicable for leukemia patients).
  • International Normalized Ratio (INR) ≤ 1.5.
  • Serum amylase and lipase ≤ upper limit of normal (ULN).
  • All patients had adequate organ function defined as described below:
  • Potassium, calcium (corrected for serum albumin) and magnesium within normal limits (WNL). Supplementation was allowed to meet eligibility requirements. Bisphosphonates to treat malignant hypercalcemia WERE NOT allowed.
  • Serum creatinine ≤ 1.5 x ULN or Serum creatinine >1.5 - 3 x ULN if
  • creatinine clearance by 24-hr urine was ≥ 30 mL/min/1.73m2 (≥50 mL/min/1.73m2 in the presence of proteinuria as defined by inclusion criterion #16 or
  • calculated creatinine clearance (CrCl) was ≥ 30 mL/min using the Cockroft- Gault equation CrCl = (140 - age in years) x (weight in kg) / (72 x serum creatinine in mg/dL) (if female, multiply the number by 0.85)
  • Alanine aminotransferase (AST) and/or aspartate aminotransferase (ALT) ≤ 3.0 x upper limit of normal range (ULN)
  • Total serum bilirubin within normal range (or ≤ 1.5 x ULN)
  • Urine dipstick reading: Negative for proteinuria or, if documentation of +1 results for protein on dipstick reading, then total urinary protein ≤ 500 mg and measured creatinine clearance ≥ 50 mL/min/1.73m2 from a 24 hour urine collection.
  • For Leukemia patients, peripheral blast counts < 50,000 blasts/mm3

Who cannot join

  • Patients eligible for this study did not meet any of the following criteria:
  • Patients who received prior treatment with dovitinib (TKI258).
  • Patients with a known hypersensitivity to dovitinib (TKI258) or to its excipients.
  • Patients with brain metastasis or history of brain metastasis or leptomeningeal carcinomatosis.
  • Patients with diarrhea ≥ CTCAE grade 2.
  • Patients with neuropathy ≥ CTCAE grade 2.
Show all 48Show fewer
  • Patients with acute or chronic pancreatitis.
  • Patients with external biliary drains.
  • Patients with a history of pulmonary embolism (PE), or untreated deep venous thrombosis (DVT) ≤ 6 months prior to starting study drug. Note: Patients with recent DVT who were treated with therapeutic anti-coagulant agents for at least 6 weeks are eligible.
  • Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:
  • History or presence of serious uncontrolled ventricular arrhythmias.
  • Clinically significant resting bradycardia.
  • LVEF assessed by either 2-D echocardiogram (ECHO) < 50% or lower limit of normal (whichever was the higher), or 2-D multiple gated acquisition scan (MUGA) < 45% or lower limit of normal (whichever was the higher).
  • Any of the following within 6 months prior to starting study drug: myocardial infarction (MI), severe/unstable angina, coronary artery bypass graft (CABG), congestive heart failure (CHF), cerebrovascular accident (CVA), transient ischemic Attack (TIA).
  • Uncontrolled hypertension defined by a SBP ≥ 160 mm Hg and/or DBP ≥ 100 mm Hg, with or without anti-hypertensive medication(s). Initiation or adjustment of antihypertensive medication(s) was allowed prior to study entry.
  • Patients with uncontrolled diabetes mellitus.
  • Patients with clinical evidence of active CNS leukemia.
  • Patient who received Allogeneic stem cell transplant and/or had active has graft-versus host disease (GVHD).
  • Patient received Autologous stem cell transplant within last 4 weeks.
  • Impairment of GI function or GI disease that could significantly alter the absorption of dovitinib (e.g. severe ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
  • Any other condition that was, in the Investigator's judgment, contraindicate patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g. infection/inflammation, intestinal obstruction, unable to swallow oral medication, social/psychological complications.
  • Patients who were treated with any hematopoietic colony-stimulating growth factors (e.g.,G-CSF, GM-CSF) ≤ 2 weeks prior to starting study drug. Erythropoietin or darbepoetin therapy, if initiated at least 2 weeks prior to enrollment, could be continued. Restriction was not applicable for patients with Leukemia.
  • Patient who received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, monoclonal antibodies or mitomycin-C) prior to starting study drug or who had not recovered to a grade 1 from side effects of such therapy (except for alopecia and neuropathy). Patients with leukemia could receive therapy with hydroxyurea and/or steroids for the purpose of cytoreduction but must discontinue use prior to first dose of study drug.
  • Patients who received the last administration of an anticancer small molecule therapy (e.g. sunitinib, sorafenib, pazopanib, axitinib, everolimus, temsirolimus, ridaforolimus) ≤ 2 weeks prior to starting study drug, or who had not recovered from the side effects of such therapy.
  • Patients not able to discontinue their current anti-cancer therapy prior to first dose of study drug.
  • Patients who received radiotherapy ≤ 4 weeks prior to starting the study drug or who had not recovered from radiotherapy-related toxicities (note: palliative radiotherapy for bone lesions ≤ 2 weeks prior to starting study drug is allowed).
  • Patients who had undergone major surgery (e.g., intra-thoracic, intra-abdominal, intrapelvic) ≤ 4 weeks prior to starting study treatment or who had not recovered from side effects of such surgery.
  • Patient was currently receiving antiplatelet therapy of prasugrel or clopidogrel, or full dose anticoagulation treatment with therapeutic doses of warfarin. However, treatment with low doses of warfarin (e.g., ≤ 2 mg/day) or locally accepted low doses of acetylsalicylic acid (up to 100 mg daily) to prevent cardiovascular events or strokes was allowed.
  • Patients with another primary malignancy within 3 years prior to starting study treatment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix.
  • Cirrhosis of the liver or known hepatitis B or C infection that was either acute or was considered chronic because the virus did not become undetectable:
  • Hepatitis C Virus (HCV) infection: acute or chronic infection as depicted by a positive HCV RNA testing (note: in a patient with known anti-HCV but with a negative test for HCV RNA, re-testing for HCV RNA 4-6 months later was requested to confirm the resolution of HCV infection).
  • Hepatitis B Virus (HBV) infection: acute infection (HBsAg+ with or without HBeAg+ or detectable serum HBV DNA), HBV carriers as evidence by ongoing presence of HBsAg and detectable serum HBV DNA levels.
  • Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing was not mandatory).
  • Patients who received investigational agents within ≤ 5t1/2 of the agent (or ≤ 4 weeks when half-life was unknown) prior to starting study drug.
  • Patient with history of non-compliance to medical regimen.
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they were using highly effective methods of contraception (defined below). Highly effective contraception had to be used by both sexes (female patients and their male partners) during study treatment and for 30 days after the last doseof study medication.
  • Highly effective contraception methods included:
  • Total abstinence (when this was in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post- ovulation methods) and withdrawal were not acceptable methods of contraception
  • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment.
  • In case of oophorectomy alone, only when the reproductive status of the woman was confirmed by follow up hormone level assessment
  • Male sterilization (at least 6 months prior to screening). For female patients on the study the vasectomized male partner was the sole partner for that subject.
  • Combination of the following (a+b):
  • Placement of an intrauterine device (IUD) or intrauterine system (IUS)
  • Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
  • Oral, implantable, or injectable hormone contraceptives might be affected by cytochrome P450 interactions, and were therefore not considered effective for this study Women of child-bearing potential (sexually mature women) who had not undergone a hysterectomy or who were not naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months), were required to have a negative serum pregnancy test ≤ 14 days prior to starting study drug.
  • Post-menopausal women were allowed to participate in this study. Women were considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks prior to entry in the study. In the case of oophorectomy alone, only when the reproductive status of the woman was confirmed by follow up hormone level assessment, then she was considered not of child bearing potential.
  • Fertile males not willing to use contraception. Fertile males must use condom with spermicide. Highly effective contraception, as defined above, was to be used by both sexes (male patients and their female partners) during study treatment and for 90 days after the last dose of study medication and was not to father a child in this period. A condom was required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.

Trial locations and contacts

49 sites in 1 country.

49 sites in 1 country

United States49 sites

  • University of Michigan Int. Medicine Oncology

    Ann Arbor, Michigan, 48109

  • University Cancer & Blood Center, LLC

    Athens, Georgia, 30607

  • Austin Cancer Centers Austin Cancer Center (2)

    Austin, Texas, 78759

  • St. Agnes Hospital St. Agnes Hospital (2)

    Baltimore, Maryland, 21229

  • St. Charles Cancer Center

    Bend, Oregon, 97701

  • Billings Clinic Onc Dept

    Billings, Montana, 59107

  • Alabama Oncology

    Birmingham, Alabama, 35211

  • Waverly Hematology Oncology

    Cary, North Carolina, 27518

  • Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology

    Chattanooga, Tennessee, 37404

  • Lurie Children's Hospital of Chicago Developmental Therapeutics

    Chicago, Illinois, 60611

  • Oncology Hematology Care, Inc. Oncology Hematology Care (2)

    Cincinnati, Ohio, 45242

  • Cleveland Clinic Foundation Cleveland Clinic (19)

    Cleveland, Ohio, 44195

  • Texas Oncology Texas Oncology - Sammons

    Dallas, Texas, 75246

  • Texas Oncology Midtown Texas Oncology

    Dallas, Texas, 75251

  • Providence Regional Cancer Partnership Providence Reg. Cancer (2)

    Everett, Washington, 98201

  • Virginia Cancer Specialists Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Highlands Oncology Group SC

    Fayetteville, Arkansas, 72703

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Rocky Mountain Cancer Centers Rocky Mountain Cancer Centers

    Greenwood Village, Colorado

  • Memorial Cancer Institute Memorial Healthcare System

    Hollywod, Florida, 33021

  • Oncology Consultants Oncology Group

    Houston, Texas, 77024

  • MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (3)

    Houston, Texas, 77030

  • Indiana University Indiana Univ. - Purdue Univ.

    Indianapolis, Indiana, 46202

  • Cancer Specialists of North Florida Cancer Specialists (2)

    Jacksonville, Florida, 32256

  • Horizon Oncology Center Horizon Oncology Ctr.

    Lafayette, Indiana, 47905

  • Comprehensive Cancer Centers of Nevada CCC of Nevada- Southwest (2)

    Las Vegas, Nevada, 89109

  • Southeast Nebraska Oncology Cancer Center

    Lincoln, Nebraska, 68510

  • NorthWest Georgia Oncology Centers NW Georgia Oncology

    Marietta, Georgia, 30060

  • The West Clinic

    Memphis, Tennessee, 38120

  • Aurora Research Institute

    Milwaukee, Wisconsin, 53226

  • Medical College of Wisconsin Cancer Ctr.-Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • Minnesota Oncology Hematology, P.A. Minnesota Oncology Hematology

    Minneapolis, Minnesota, 55404

  • Intermountain Medical Center Intermountain Healthcare

    Murray, Utah, 84157

  • Sarah Cannon Research Institute Tennessee Oncology

    Nashville, Tennessee, 37203

  • Whittingham Cancer Center Norwalk Hospital

    Norwalk, Connecticut, 06856

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Illinois Cancer Care

    Peoria, Illinois, 61615-7828

  • PCR Oncology

    Pismo Beach, California, 93449

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232-1305

  • Oregon Health & Science University OHSU Knight Cancer Institute

    Portland, Oregon, 97239

  • Rhode Island Hospital Rhode Island Hosp. (2)

    Providence, Rhode Island, 02903

  • Sarcoma Oncology Center

    Santa Monica, California, 90403

  • Gibbs Cancer Center & Research Institute Spartanburg Reg. Healthcare

    Spartanburg, South Carolina, 29303

  • Evergreen Hematology & Oncology

    Spokane, Washington, 99218

  • Northwest Medical Specialties Hematology/Oncology

    Tacoma, Washington, 98405

  • Space Coast Medical Associates Space Coast Cancer Center

    Titusville, Florida, 32796

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Wenatchee Valley Medical Center Wenatchee Valley

    Wenatchee, Washington, 98801

  • Yakima Valley Memorial Hospital North Star Lodge Cancer Center

    Yakima, Washington, 98902

Other trials in United States

About this study

Official title: Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module 2 - Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib Including Tumors With Mutations or Translocations of FGFR, PDGFR, VEGF, cKIT, FLT3, CSFR1, Trk and RET

The purpose of this signal seeking study was to determine whether treatment with dovitinib (TKI258) demonstrated sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.

Read the detailed description

This was a phase II, open label study to determine the efficacy and safety of treatment with dovitinib (TKI258) in patients with a diagnosis of select solid tumors or hematological malignancies that have been pre-identified (prior to study consent) to have mutations, translocations or amplifications and whose disease has progressed on or after standard treatment.

Genomic profiling is becoming more accessible to patients and their physicians. As such, more patients have been identified with potentially-actionable mutations, translocations or amplifications but do not have access to targeted drug treatment. This is a signal-seeking study to match patients with tumor pathway activations inhibited by dovitinib to the RTK inhibitor dovitinib. Pre-identification of mutations, translocations, or amplifications will be performed locally at a CLIA certified laboratory prior to participation on the trial.

For the purpose of this study, genomic profiling is not considered part of screening. Informed consent must be signed before any screening activities take place. Once eligibility (screening criteria met) has been confirmed by Novartis, the patient will initiate therapy with dovitinib single-agent. The patient may not receive any additional anti-cancer therapy during treatment with dovitinib.

Patients received study treatment until disease progression (assessed by investigator per RECIST 1.1 or appropriate hematologic response criteria), unacceptable toxicity, death or discontinuation from study treatment for any other reason (e.g., withdrawal of consent, start of a new anti-neoplastic therapy or at the discretion of the investigator), otherwise known as End of Treatment. All patients who discontinue from study treatment due to disease progression must have their progression clearly documented.

Disease assessment (by RECIST 1.1 or appropriate hematological response criteria) will be performed every 8 weeks (±4 days) after first dose of study drug (Day 1 of every odd cycle), until disease progression or end of treatment, whichever occurs first. The frequency of disease assessment may be reduced to every 12 weeks for patients who have at least 4 post-baseline disease assessments and are clinically stable (except AML patients). Scans was assessed locally by the investigator. After discontinuation of treatment, patients, regardless of reason for treatment discontinuation, will be followed for safety for 30 days after the last dose.

All patients will be followed for survival status every 3 months for 2 years after the last patient has enrolled in the study,regardless of treatment discontinuation reason (except if consent is withdrawn or patient is lost to follow-up)

Being tested
Dovitinib (TKI258)
Keywords
Solid tumor malignancy, hematologic malignancy, mutation, translocations, FGFR, PDGFR, VEGF, cKIT, FLT3, CSR1, Trk, RET, TKI258, dovitinib, signature, AML, acute myelogenous leukemia, GIST, gastrointestinal stromal tumor, Head and Neck cancer
Medical subject headings
Hematologic Neoplasms, Leukemia, Myeloid, Acute, Gastrointestinal Stromal Tumors, Head and Neck Neoplasms, Melanoma, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Ovarian Neoplasms

What participants receive

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

  • Dovitinib (TKI258)Drug

    Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.

Study groups in NCT01831726
Study groupRoleWhat they receive
TKI258ExperimentalDovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
Receives: Drug: Dovitinib (TKI258)

What is being measured

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

  1. Clinical Benefit Rate (CBR)

    CBR determined by investigator assessment for each tumor assessment \& defined as responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) ≥ 16 wks. Confirmed CR/PR or SD prior to 16 wks,but discontinued prior to 16 wks for reasons other than progressive disease,will have their clinical benefit defined non-evaluable; confirmed CR/PR or SD prior to 16 wks,but progressed prior to 16 wks,will be considered not achieving clinical benefit;if CR/PR/SD occurred prior to 16 wks,but progressed at or after 16 wks without evidence of CR/PR/SD at or after 16 wks,will also be considered not achieving clinical benefit. CBR will be analyzed by comparing achieved CBR with a historical control rate of each tumor type,\& if there is at least 90% probability that the response rate in a tumor type exceeds the historical rate,then the tumor type will be considered a success. CBR: CR+PR+SD the assessment criteria was RECIST 1.1

    Measured: Week 16

Secondary outcomes (3)

  1. Overall Response (OR) of Partial Response (PR) or Greater

    Overall Response (OR) of Partial Response (PR) or greater based on local investigator assessment. For patients with solid tumors, the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR. For hematologic tumors other appropriate hematological response criteria will apply and are included in the appendices. ORR: CR+PR

    Measured: Week 16

  2. Progression-Free Survival (PFS)

    Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause.

    Measured: 36 months

  3. Overall Survival (OS)

    Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact

    Measured: 36 months

Timeline

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

  1. First posted15 Apr 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionDec 2015
  4. Study completionDec 2015

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
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01831726
Sponsor's protocol ID
CTKI258AUS26
Acronym
SIGNATURE
Status last verified
Jan 2017
First submitted
11 Apr 2013
Last updated
20 Mar 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dovitinib (TKI258) in people with Tumor Pathway Activations Inhibited by Dovitinib, run by Novartis Pharmaceuticals at 49 sites in United States.

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 39 inclusion and 48 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 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States. 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?

Yes. Results are posted in the registry (first posted 20 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Clinical Benefit Rate (CBR) (time frame: Week 16). 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 NCT01831726.

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 Mar 2017.

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