AzTrials
AzTrials

Relapsed or Refractory Multiple MyelomaPhase 1/2NCT01866293

Cabozantinib (XL184) in Patients With Relapsed or Refractory Myeloma

A Phase 1/2 study testing Cabozantinib (XL184) in people with Relapsed or Refractory Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 5 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

This study is an open label phase I/II trial to investigate the safety and efficacy of Cabozantinib for patients with relapsed or refractory myeloma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed or Refractory Multiple Myeloma
What is being tested?
Cabozantinib (XL184)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
5 sitesUnited States
Study dates
28 May 2013to 18 Aug 2016
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • MSKCC confirmed diagnosis of multiple myeloma that has relapsed or is resistant after therapy with at least one immunomodulatory drug (i.e. lenalidomide, thalidomide) and at least one proteasome inhibitor.
  • Age ≥ 18 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • The subject has organ and marrow function as follows:
  • Absolute neutrophil count (ANC) ≥ 1500/mm3 (G-CSF is allowed).
  • Platelets ≥ 50,000/mm3 or 30,000 (if marrow infiltrated with myeloma; no platelet transfusions are allowed in the 7 days prior to screening)
Show all 16Show fewer
  • Hemoglobin ≥ 8 g/dL (with transfusions). Bilirubin ≤ 1.5 × the upper limit of normal (ULN).
  • Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance ≥ 50 mL/min.
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN if no liver involvement, or ≤ 5 × ULN with liver involvement.
  • Lipase < 1.5 x the upper limit of normal.
  • Patient must be able/willing to undergo bone marrow aspirate and biopsy.
  • Subjects with brain metastasis or CNS disease are considered eligible if the subject has not received radiation therapy for brain metastasis within 2 weeks of enrollment and has been on a stable dose of steroids for 2 or more weeks.
  • Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (e.g. male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control.
  • Women of childbearing potential must have a negative pregnancy test at screening. Women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Postmenopause is defined as:
  • Amenorrhea ≥ 12 consecutive months without another cause OR
  • A documented serum follicle-stimulating hormone (FSH) level > 35 mIU/mL (for women with irregular menstrual periods and on hormone replacement therapy)

Who cannot join

  • The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 2 weeks, or nitrosoureas/ mitomycin C within 6 weeks before the first dose of study treatment.
  • The subject has received radiation therapy within 14 days of the first dose of study treatment.
  • The subject has received prior treatment with a small molecule kinase inhibitor or a hormonal therapy (including investigational kinase inhibitors or hormones) within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment.
  • The subject has not recovered from toxicity due to all prior therapies (i.e., return to pretherapy baseline or to Grade 0 or 1).
  • The subject has prothrombin time (PT)/ International Normalized Ratio (INR) or partial thromboplastin time (PTT) test results at screening that are ≥1.3 ×ULN.
  • The subject has uncontrolled significant intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled congestive heart failure, unstable angina pectoris within 6 months, stroke within 6 months, myocardial infarction within 6 months, or uncontrolled cardiac arrhythmias, uncontrolled hypertension.
Show all 25Show fewer
  • Corrected QTc of greater than 500msec.
  • The subject is pregnant or breastfeeding.
  • The subject has a previously identified allergy or hypersensitivity to components of the study treatment formulation.
  • The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or Factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel). Low dose aspirin (≤ 81 mg/day), low-dose warfarin (≤ 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted.
  • The subject has experienced any of the following within 6 months before the first dose of study treatment:
  • clinically-significant hematemesis or gastrointestinal bleeding
  • hemoptysis of ≥ 0.5 teaspoon (2.5ml) of red blood
  • any other signs indicative of pulmonary hemorrhage The subject has radiographic evidence of cavitating pulmonary lesion(s)
  • The subject has tumor in contact with, invading or encasing major blood vessels
  • Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:
  • Any of the following at the time of screening i) intra-abdominal tumor/metastases invading GI mucosa ii) active peptic ulcer disease, iii) inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis iv) malabsorption syndrome
  • Any of the following within 6 months before the first dose of study treatment:
  • history of abdominal fistula ii) gastrointestinal perforation iii) bowel obstruction or gastric outlet obstruction iv) intra-abdominal abscess. Note: Complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more that 6 months ago.
  • History of major surgery as follows:
  • Major surgery within 3 months of the first dose of cabozantinib. Major surgery within 6 months of the first dose of cabozantinib if there are complications related to wound healing.
  • Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications (particularly when associated with delayed or incomplete healing) within 28 days. Note: Complete healing following abdominal surgery must be confirmed prior to initiating treatment with cabozantinib even if surgery occurred more that 28 days ago.
  • Other disorders associated with a high risk of fistula formation including PEG tube placement within 3 months before the first dose of study therapy or concurrent evidence of intraluminal tumor involving the trachea and esophagus.
  • Concurrent malignancy except for treated non-melanoma skin cancer and cervical carcinoma in situ.
  • The subject requires chronic concomitant treatment of strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's Wort).

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Memoral Sloan Kettering Cancer Center

    Basking Ridge, New Jersey

  • Memorial Sloan Kettering Cancer Center @ Suffolk

    Commack, New York, 11725

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Cancer Center at Mercy Medical Center

    Rockville Centre, New York, 11570

  • Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center

    Sleepy Hollow, New York, 10591

Other trials in United States

About this study

Official title: A Phase I/II Trial of Cabozantinib (XL184) in Patients With Relapsed or Refractory Myeloma

This study is an open label phase I/II trial to investigate the safety and efficacy of Cabozantinib for patients with relapsed or refractory myeloma.

Being tested
Cabozantinib (XL184)
Keywords
Cabozantinib (XL184), 12-240
Medical subject headings
Recurrence, Multiple Myeloma

What participants receive

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

  • Cabozantinib (XL184)Drug

Study groups in NCT01866293
Study groupRoleWhat they receive
Cabozantinib (XL184)ExperimentalEligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
Receives: Drug: Cabozantinib (XL184)

What is being measured

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

  1. Maximally Tolerated Dose

    This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.

    Measured: 1 year

Secondary outcomes (4)

  1. Overall Response Rate

    IMWG Criteria for Response, Progression and Relapse in Multiple Myeloma Patients

    Measured: 1 year

  2. Safety and Toxicity in This Patient Population

    Safety assessments and toxicity grading will follow CTCAE Version 4 Grade

    Measured: 1 year

  3. Time to Progression (TTP)

    Measured: 1 year

  4. Duration of Response (DOR)

    Measured: 1 year

Timeline

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

  1. First posted31 May 2013 (estimated)
  2. Study start28 May 2013
  3. Primary completion18 Aug 2016
  4. Study completion18 Aug 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01866293
Sponsor's protocol ID
12-240
Status last verified
Feb 2017
First submitted
28 May 2013
Last updated
30 Aug 2017

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cabozantinib (XL184) in people with Relapsed or Refractory Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 5 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 16 inclusion and 25 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 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 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?

Yes. Results are posted in the registry (first posted 30 Aug 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?

Maximally Tolerated Dose (time frame: 1 year). 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 NCT01866293.

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 30 Aug 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in