Status:
COMPLETED
Study of MLN2480 in Participants With Relapsed or Refractory Solid Tumors Followed by a Dose Expansion in Participants With Metastatic Melanoma
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Melanoma
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 pa...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Informed consent.
- Male or female participants 18 years or older.
- Dose Escalation phase: Participants 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 participants 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 less than or equal to (\<=) 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.
- Participants who do not have hypo- or hyperthyroidism.
- Ability to swallow and retain oral medication.
- Female participants who are postmenopausal 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 participants 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 participants 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 participant unsuitable for enrollment.
Exclusion
Key Trial Info
Start Date :
September 15 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2018
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT01425008
Start Date
September 15 2011
End Date
October 16 2018
Last Update
August 10 2020
Active Locations (16)
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1
San Francisco, California, United States
2
Denver, Colorado, United States
3
Augusta, Georgia, United States
4
Indianapolis, Indiana, United States