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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Melanoma, Metastatic Melanoma, Solid Tumor

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of adverse events, serious adverse events, dose-limiting adverse events within the first cycle, and deaths

Outcome Description:

Safety and tolerability of MLN2480

Outcome Time Frame:

From first dose of study treatment to end of study visit, approximately 1 year and 30 days

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C28001

NCT ID:

NCT01425008

Start Date:

September 2011

Completion Date:

July 2015

Related Keywords:

  • Melanoma
  • Metastatic Melanoma
  • Solid Tumor
  • Melanoma
  • Neoplasms

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
The START CenterSan Antonio, Texas  78229