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A Phase II Study of the Hsp90 Inhibitor, STA-9090, in Patients With Relapsed or Refractory Small Cell Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Small Cell Lung Cancer

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Trial Information

A Phase II Study of the Hsp90 Inhibitor, STA-9090, in Patients With Relapsed or Refractory Small Cell Lung Cancer

Small cell lung cancer (SCLC) is a chemotherapy and radiotherapy sensitive tumor, but with
very high rates of relapse and metastasis, resulting in a very poor outcome. Among
limited-stage patients, the relapse rate is at least 80% and among extensive-stage patients,
the relapse rate is 95-98%. The impetus to develop more effective therapies against novel
targets in SCLC is therefore high. Hsp-90 inhibitors are a new class of drugs with important
anti-malignant potential in a variety of tumor types because of the reliance of multiple
oncoproteins on Hsp90 function.

Although small cell neuroendocrine tumors generally carry many mutated oncoproteins, without
clearly defined clients for Hsp90 mediating inhibitor effects in these cells, a recent study
demonstrated that Hsp90 inhibition causes massive apoptosis by activating the intrinsic
apoptotic pathway in a number of SCLC cell lines. SCLC is a particularly attractive target
for apoptosis inducing drugs because of high growth rates and evidence of molecular
alterations affecting apoptotic mechanisms. STA-9090 is a novel, small-molecule inhibitor of
Hsp90. Unlike earlier generations of Hsp90 inhibitors, STA-9090 has been shown to be a
potent inducer of apoptosis in a variety of cell lines and has anti-tumor activity in
multiple types of human xenografts. As was seen with other Hsp90 inhibitors, STA-9090 also
induces apoptosis in a number of SCLC cell lines (T. Shimamura and G. Shapiro, personal

Based on the anti-tumor potential seen pre-clinically with Hsp90 inhibition, the potent
effects of STA-9090 seen pre-clinically as compared with other inhibitors in the same class,
as well as early data suggesting safety and tolerability of this drug in the Phase I
setting, we are evaluating the single-agent activity of STA-9090 in a Phase II trial of
patients with relapsed or refractory small cell lung cancer.

Inclusion Criteria:

- Histologically confirmed diagnosis of small cell lung cancer and confirmed
progressive disease by radiographic study

- Subjects with brain metastases will be allowed if they have been treated with surgery
and/or radiation therapy > 21 days prior, are asymptomatic, and are stable for at
least 1 week off steroids

- Must have measurable disease

- >/= 18 years of age

- Life expectancy of greater than 12 weeks

- EGOG performance status 0 or 1

- Lab values must be within limits outlined in the protocol

- Not pregnant or breastfeeding

- Women of childbearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and
for the duration of study participation

- Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests, and other study procedures.

- Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- Chemotherapy or radiotherapy within 3 weeks or within 5 half-lives of previous

- History of severe allergic or hypersensitivity reactions to taxanes.

- Subjects who have not recovered from adverse events or toxicities due to agents
administered more than 4 weeks earlier to a grade 1 or less

- Not receiving any other study agents

- History of or current coronary artery disease, myocardial infarction, angina
pectoris, angioplasty or coronary bypass surgery.

- Baseline QTc > 470 msec or previous history of QT prolongation while taking other

- Ventricular ejection fraction of < 55%.

- History or current uncontrolled dysrhythmias, or requirement for antiarrhythmic
medications, or Grade 2 or greater left bundle branch block.

- ECG with clinically significant ventricular arrhythmias or ischemia

- Major surgery within 4 weeks of starting treatment

- Poor venous access necessitating use of indwelling catheter for IV therapy

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance

- History of another malignancy unless disease-free for 3 years and deemed to be at low
risk for recurrence

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free rate at 8 weeks in subjects with relapsed or refractory SCLC who have received

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Leena Gandhi, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

July 2010

Completion Date:

Related Keywords:

  • Small Cell Lung Cancer
  • Hsp90 Inhibitor
  • relapsed
  • refractory
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana Farber Cancer Institute Boston, Massachusetts  02115
Massacusetts General Hospital Boston, Massachusetts  02114