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Phase I Dose Escalation Study to Determine the Safety and Pharmacokinetics of MSX-122 Administered Orally in Patients With Refractory Metastatic or Locally Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling
Solid Tumors

Thank you

Trial Information

Phase I Dose Escalation Study to Determine the Safety and Pharmacokinetics of MSX-122 Administered Orally in Patients With Refractory Metastatic or Locally Advanced Solid Tumors

Inclusion Criteria:

- Patients with pathologically confirmed advanced malignancy that is metastatic or
unresectable and which is refractory to standard therapy or for which there is no
standard therapy that provides benefit

- Measurable or non-measurable disease at baseline

- At least four weeks since the last dose of prior chemotherapy, treatment with
biologic agents, radiation therapy or investigational agents

- Patients must have recovered from the adverse effects of prior therapy at the time of
enrollment to a grade one or less(excluding alopecia)

- Patient will not be treated with any other chemotherapy, immunotherapy, radiotherapy
or investigational drug while enrolled on this protocol

- Age >/= 18 year, male or female patients

- Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2

- Life expectancy of greater than 3 months following study entry

- Adequate renal function, defined by serum creatinine less than or equal to 1.5 x ULN

- Adequate hepatic function as defined by aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) levels In the presence of liver metastasis, adequate hepatic function is defined as ALT and
AST than or equal to 2.5 x ULN. In the presence of extensive bone metastases, alkaline
phosphatase is defined as less than or equal to 5 x ULN

- Adequate bone marrow function as defined by an absolute neutrophil count of >/=
1,500/mm3 (>/=1.5 x 10^9/L), platelet count of >/= 100,000/mm3 (>/=100 x10^9/L) and
hemoglobin of >/= 8 gm/dL

- Left ventricular ejection fraction of 50% or greater as measured by echocardiogram or

- For women of childbearing potential, a negative serum pregnancy test result at

- Women of child-bearing potential or men whose sexual partners are women of
child-bearing potential must agree to use two methods of adequate contraception (e.g.
hormonal and barrier method of birth control) prior to study entry, for the duration
of the study, and for 21 days after the last dose of study medication. Acceptable
methods of contraception include condoms, diaphragm ,birth control pills, birth
control patch, hormonal injections, intrauterine device (IUD), surgical sterilization
and/or under the skin implants

- Signed and dated institutional review board (IRB)-approved informed consent before
any protocol-specific screening procedures are performed

Exclusion Criteria:

- Patients with uncontrolled concurrent illness, including but not limited to: ongoing
or active infection; uncontrolled arterial hypertension (>/= 140/90 mm of mercury on
medications); uncontrolled endocrine diseases (e.g. diabetes mellitus, hypothyroidism
or hyperthyroidism, adrenal disorder); altered mental status or psychiatric
illness/social situations that would limit compliance with study requirements and/or
obscure study results

- Patients with a history of a cardiovascular illness including but not confined to:
CHF (grade III or IV NYHA); a history of angina pectoris within the previous year;
history of any cardiac arrhythmia; QTc prolongation as determined by Bazett's formula
and defined as QTc interval >480 msec (including patients on medication which may
prolong QTc), or history of myocardial infarction within one year of study enrollment

- Patients with leukemias or myelodysplastic syndrome (MDS)

- Immunocompromised patients, including subjects known to be infected by human
immunodeficiency virus (HIV)

- Patients with a history of autologous BMT within the previous five years. Patients
with organ transplants, or allogeneic BMT will not be eligible for the study

- Patients with untreated or uncontrolled brain metastasis, or patients with
leptomeningeal disease

- Patients unable to swallow oral medications or with pre-existing gastrointestinal
disorders that might interfere with proper absorption of the oral drugs (e.g. WDHA
syndrome, carcinoid syndromes, diarrhea due to infections, malabsorption syndromes
secondary to surgery or chemotherapy).

- Patients with a history of major surgery within 28 days of first receipt of study

- Nursing or pregnant women

- Patients with any other diseases, metabolic dysfunction, physical examination finding
or clinical laboratory finding that in the opinion of the investigator,
contraindicates the use of an investigational drug, or that may render the patient at
excessively high risk for treatment complications

- Patients with a history of one or more other primary carcinomas

- Patients with a known hypersensitivity to any of the components of the drug product

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerated dose (MTD) and the recommended Phase II dose(s) and schedule of MSX-122

Outcome Time Frame:

12 Months Estimated

Safety Issue:


Principal Investigator

Jennifer J. Wheler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

November 2007

Completion Date:

March 2009

Related Keywords:

  • Solid Tumors
  • Neoplasms



U.T.M.D. Anderson Cancer Center Houston, Texas  77030