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A Phase I Dose Escalation Study of the PKC Inhibitor, Aurothiomalate (ATM) in Patients With Advanced Non-Small Cell Lung Cancer

Phase 1
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

A Phase I Dose Escalation Study of the PKC Inhibitor, Aurothiomalate (ATM) in Patients With Advanced Non-Small Cell Lung Cancer


- To determine the maximum tolerated dose of gold sodium thiomalate in patients with
advanced non-small cell lung cancer.

- To describe the toxicities associated with this treatment.

- To describe any preliminary evidence of biologic activity.

- To further assess the correlation between PKCι expression and the antitumor effects of
gold sodium thiomalate.

- To study the association of clinical (toxicity and/or tumor response or activity) with
pharmacokinetic/pharmacodynamic parameters.

- To describe anti-proliferative activity of gold sodium thiomalate through
3-deoxy-3-[^18F]-fluorothymidine positron emission tomography imaging.

OUTLINE: This is a dose-escalation study of gold sodium thiomalate.

Patients receive gold sodium thiomalate intramuscularly on days 1, 8, 15 and 22. Treatment
repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable
toxicity. Patients then receive gold sodium thiomalate once every 4 weeks until a total
cumulative dose of 1 gram is delivered.

Blood samples are collected at baseline and prior to therapy in weeks 3, 5, 7, 9, and 11.
Samples are analyzed by mass spectometry for pharmacokinetics. Paraffin-embedded tumor
tissue samples are analyzed for PKC_l expression and antitumor activity. Antiproliferative
effects of gold sodium thiomalate are analyzed by 3-deoxy-3-[^18F]-fluorothymidine positron
emission tomography imaging.

Inclusion Criteria


- Histologically confirmed advanced non-small cell lung cancer

- No known standard therapy for disease that is potentially curative or definitely
capable of extending life expectancy

- No symptomatic or worsening CNS metastases despite optimal therapy


- ECOG performance status 0-2

- Life expectancy ≥ 12 weeks

- ANC ≥ 1,500/µL

- Platelet count ≥ 100,000/µL

- Total bilirubin ≤ 2 times upper limit of normal (ULN)

- AST ≤ 3 times ULN (5 times ULN if liver involvement)

- Creatinine ≤ 1.2 times ULN

- Hemoglobin ≥ 9.0 g/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Must be willing to provide blood and tissue samples

- No uncontrolled infection

- No New York Heart Association class III or IV heart disease

- No known allergy to gold sodium thiomalate


- Recovered from acute, reversible effects of prior chemotherapy regardless of interval
since last treatment

- No prior chemotherapy within the past 3 weeks

- No prior mitomycin C or nitrosoureas within the past 6 weeks

- No prior immunotherapy within the past 3 weeks

- No prior biologic therapy within the past 3 weeks

- No prior radiotherapy within the past 3 weeks

- No prior radiotherapy to > 25% of bone marrow

- No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary
therapy considered investigational (i.e., utilized for a non-FDA-approved indication
and in the context of a research investigation)

- No concurrent prophylactic colony stimulating factors

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Safety Issue:


Principal Investigator

Julian Molina, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic



Study ID:




Start Date:

January 2007

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Mayo Clinic - Jacksonville Jacksonville, Florida  32224
Mayo Clinic Cancer Center Rochester, Minnesota  55905