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A Phase II Study of IPI-204, A Novel Hsp90 Inhibitor in NSCLC Patients With ALK Translocations

Phase 2
18 Years
Not Enrolling
Lung Cancer, Stage IIIb Lung Cancer, Stage IV Lung Cancer

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Trial Information

A Phase II Study of IPI-204, A Novel Hsp90 Inhibitor in NSCLC Patients With ALK Translocations

- Participants will receive the study drug (IPI-504) twice weekly for two weeks followed
by 10 days without study treatment. This 3-week period is called a cycle. Participants
will receive a total of 4 doses per cycle. On the days the participant receives study
drug, they will come to the clinic and be given the IPI-504 by being. Participants
will continue to receive study drug for additional cycles as long as they are
benefiting from it and do not experience any severe side effects.

- Participants will have CT scans to assess the size and location of their tumor. They
may also have a PET scan or a combination of PET/CT scans. Imaging will be done at the
beginning of treatment and every five to six weeks while on study to assess how the
tumor is responding to IPI-504.

- The following tests and procedures will be done on the prior to the first dose of
IPI-504: physical examination, vital signs, routine blood tests, EKGs, serum or urine
pregnancy test (for women of child-bearing potential).

- After the first dose of IPI-504, the following tests and procedures will be done: EKGs,
vital signs (pulse only).

- For all other visit days throughout the study, the following exams, tests and
procedures will be done: physical examination, vital signs, blood tests, tumor imaging
assessments, MRI of the brain (if applicable), review of medications and answer
questions about any side effects or changes in health.

- After the final dose of study drug the following tests and procedures will be done
within 30 days: physical examination, ECOG Performance status, blood tests, review of
medications and answer questions about any side effects of changes in health.

Inclusion Criteria:

- Patients must have pathologically confirmed diagnosis of Stage IIIb (with malignant
pleural or pericardial effusion), Stage IV, or recurrent NSCLC.

- Patients must have demonstrated ALK mutation

- There is no requirement for a minimum or maximum number of prior therapies, however,
patients must have refused, be intolerant to or already received at least on standard
systemic therapy for lung cancer

- Measureable disease by RECIST criteria. If a patient has received radiation therapy
then measurable disease must be outside the radiation field.

- 18 years of age or older

- Life expectancy of at least 3 months

- ECOG performance status of 0-2

- Baseline studies for determining eligibility, except for ALK mutation status, must be
completed within 30 days of first study dose.

- CT scan must be completed within 28 days prior to first study dose

- Women of child-bearing potential (WBCP) defined as a sexually mature woman who has
not undergone a hysterectomy or who has not been naturally post-menopausal for at
least 24 consecutive months must have a negative serum or urine pregnancy test within
2 weeks of first study dose

- All WCBP and all sexually active male patients must agree to use adequate methods of
birth control throughout the study

Exclusion Criteria:

- Treatment for NSCLC with any approved or investigational product within 2 weeks of
Cycle 1, Dose 1 for any small molecule therapy; within 4 weeks of Cycle 1, Dose 1 for
any biologic or any conventional chemotherapy.

- Concurrent radiation therapy is not permitted

- Use of a medication or food that is clinically relevant CYP3A inhibitor or inducer
within 2 weeks prior to Cycle 1, Dose 1

- Laboratory values as outlined in the protocol

- Baseline QT corrected using Fridericia's correction method (QTcf) > 470ms. Patients
with left bundle branch block are eligible regardless of QTcf, as long as serum
troponin is normal or undetectable

- Presence of active infection or systemic use of antibiotics within 72 hours of

- Significant co-morbid condition or disease which in the judgment of the investigator
would place the patient at undue risk or interfere with the study

- Women who are pregnant or lactating

- Previous treatment with 17-AAG, DMAG, or other known Hsp90 inhibitor

- Sinus bradycardia secondary to intrinsic conduction system disease. Patients with
sinus bradycardia secondary to pharmacologic treatment may enroll if withdrawal of
the treatment results in normalization of the resting heart rate to within normal

- Active keratitis or keratoconjunctivitis

- Alkaline phosphatase > 1.5 x ULN. Patients with bone metastases and an alkaline
phosphatase level > 1/5 x ULN and less than or equal to 3 x ULN are eligible if they
meet the criteria outlined in the protocol

- Prothrombin time (PT) and partial thromboplastin time (PTT) > 1.5 x ULN unless the
patient is receiving warfarin. If the patient is receiving warfarin, the
international normalized ratio must be within therapeutic range

- Patients with clinically active brain metastasis or an uncontrolled seizure disorder,
ongoing spinal cord compression, or carcinomatous meningitis. Patients with
clinically stable brain metastasis are eligible.

- Patients with prior hepatic resection or hepatic-directed therapy

Type of Study:


Study Design:

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

Outcome Measure:

Anti-Tumor Activity

Outcome Description:

To determine the potential anti-tumor activity of IPI-504 based on validated markers of response, including imaging studies as measured by RECIST criteria. A response rate of PR or better or SD lasting 3 months or more that is no greater than 5% will be considered evidence that IPI-504 is ineffective for this indication.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Lecia V. Sequist, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

October 2010

Completion Date:

February 2012

Related Keywords:

  • Lung Cancer
  • Stage IIIb Lung Cancer
  • Stage IV Lung Cancer
  • IPI-504
  • ALK translocation
  • Hsp90 inhibitor
  • Lung Neoplasms



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617