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Study of MLN2480 in Patients With Relapsed or Refractory Solid Tumors Followed by a Dose Expansion in Patients With Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT01425008
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

August 26, 2011
August 29, 2011
October 18, 2018
September 15, 2011
April 11, 2017   (Final data collection date for primary outcome measure)
Incidence of adverse events, serious adverse events, dose-limiting adverse events within the first cycle, and deaths [ Time Frame: From first dose of study treatment to end of study visit, approximately 1 year and 30 days ]
Safety and tolerability of MLN2480
Same as current
Complete list of historical versions of study NCT01425008 on ClinicalTrials.gov Archive Site
  • Objective response rate, duration of response, and progression-free survival [ Time Frame: Every 2 cycles after starting MLN2480 treatment, beginning on Cycle 2, Day 21 +/- 2 days, expected duration approximately 1 year ]
    Preliminary antitumor activity of MLN2480
  • Maximum observed concentration (Cmax), trough concentration (Ctrough), first time to maximum concentration (tmax), t1/2, renal clearance, and area under the plasma concentration-time curve (AUC) [ Time Frame: At multiple time points throughout Cycle 1 and Day 1 of Cycle 2, for approximately 23 days ]
    Pharmacokinetics of MLN2480
  • Inhibition of phosphorylated extracellular signal-regulated kinase (pERK) and Ki67, and Caspase-3 staining [ Time Frame: Before first dose of MLN2480 and on Day 21 ]
    Pharmacodynamics of MLN2480
Same as current
Not Provided
Not Provided
 
Study of MLN2480 in Patients With Relapsed or Refractory Solid Tumors Followed by a Dose Expansion in Patients With Metastatic Melanoma
An Open-Label, Phase 1, Dose Escalation Study of MLN2480 in Patients With Relapsed or Refractory Solid Tumors Followed by a Dose Expansion Phase in Patients With Metastatic Melanoma
This is a phase 1, multicenter, nonrandomized, open-label, dose escalation study. The study will be conducted in 2 stages, Dose Escalation and Dose Expansion. The Dose Escalation phase will include patients with solid tumors (including melanoma) who have failed or are not candidates for standard therapies or for whom no approved therapy is available. The Dose Expansion phase will include patients with metastatic melanoma.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Melanoma
  • Metastatic Melanoma
  • Solid Tumor
Drug: MLN2480
Dose Escalation Phase: patients will receive MLN2480 orally in escalating doses every other day or once weekly for three weeks of a 28-day cycle. Patients may continue treatment for additional cycles (up to 12 months) until disease progression, unacceptable toxicity, or the patient discontinues for any other reason. If it is determined that a patient would derive benefit from continued therapy beyond 12 months treatment may continue. Dose Expansion Phase: Patients will take MLN2480 at the maximum tolerated dose orally every other day or once weekly for three weeks of a 28-day cycle until disease progression, unacceptable toxicity, or the patient discontinues for any other reason. The maximum duration of treatment is 1 year unless determined that a patient would derive benefit from continued therapy beyond 12 months.
Experimental: MLN2480
Intervention: Drug: MLN2480
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
149
60
October 16, 2018
April 11, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Informed consent
  • Male or female patients 18 years or older
  • Dose Escalation phase: Patients with solid tumors (including melanoma) who have failed or are not candidates for standard therapies of for whom no approved therapy is available
  • Dose Expansion phase: Metastatic melanoma (locally advanced or metastatic melanoma)
  • Dose Expansion phase: At least 1 measurable lesion which has not been treated previously with radiotherapy. A newly arising lesion in a previously irradiated field is acceptable
  • For patients undergoing biopsy procedures: Prothrombin time (PT) and activated partial thromboplastin time (aPTT) must be within the normal range
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  • Adequate tissue sample from either archival formalin-fixed paraffin-embedded (FFPE) tumor tissue or new biopsy of tumor
  • Previous chemotherapy, immunotherapy, and hormone therapy must be completed at least 4 weeks prior to the administration of MLN2480 and radiation must be completed at least 3 weeks prior to the administration of MLN2480; all associated toxicity must be resolved to ≤ Grade 1
  • Expected survival time of at least 3 months in the opinion of the investigator
  • Patients who do not have hypo- or hyperthyroidism
  • Ability to swallow and retain oral medication
  • Female patients who are post menopausal for at least 1 year, surgically sterile, or agree to practice 2 effective methods of contraception through 3 months after the last dose of study drug or agree to practice true abstinence
  • Male patients who, even if surgically sterilized, agree to practice effective barrier contraception through 3 months after the last dose of alisertib or agree to practice true abstinence

Exclusion Criteria

  • History of any major disease that might interfere with safe protocol participation
  • Dose Expansion phase: Previous treatment with RAF or MEK inhibitors
  • Laboratory values as specified in study protocol
  • Current enrollment in any other investigational treatment study
  • Evidence of current uncontrolled cardiovascular conditions within the past 6 months
  • Prior investigational agents for malignant or non-malignant disease within 4 weeks prior to Day 1
  • Active hepatitis or human immunodeficiency virus (HIV) infection
  • Active bacterial or viral infection
  • Female patients who are pregnant or currently breastfeeding
  • Major surgery within 28 days of Day 1
  • Refractory nausea and vomiting, malabsorption, or significant bowel or stomach resection
  • Inability to comply with study requirements
  • Other unspecified reasons that, in the opinion of the investigator or Millennium, make the patient unsuitable for enrollment
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   United States
France
 
NCT01425008
C28001
2012-003397-16 ( EudraCT Number )
U1111-1164-7508 ( Registry Identifier: WHO )
13/SC/0007 ( Registry Identifier: NRES )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Takeda ( Millennium Pharmaceuticals, Inc. )
Millennium Pharmaceuticals, Inc.
Not Provided
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Takeda
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP