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A Phase II, Multi-center, Open-label Study of AUY922 Administered IV on a Once-weekly Schedule in Patients With Advanced Non-small-cell Lung Cancer Who Have Received at Least Two Lines of Prior Chemotherapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-small-cell Lung Cancer

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Trial Information

A Phase II, Multi-center, Open-label Study of AUY922 Administered IV on a Once-weekly Schedule in Patients With Advanced Non-small-cell Lung Cancer Who Have Received at Least Two Lines of Prior Chemotherapy


Inclusion Criteria:



- Patients with histologically or cytologically confirmed advanced (stage IIIB or stage
IV) NSCLC who have received at least two prior lines of treatment. Patients who, in
the investigators opinion, are deemed unsuitable for the standard 2nd line
chemotherapy will be eligible for protocol participation. One of the prior lines must
have included a platinum agent. Prior treatment with a platinum agent is not a
requirement for EGFR mutant patients and patients with EML4-ALK translocations

- Patients enrolled to the fifth stratum, modified EGFR mutant, must have documented
prior response to EGFR TKI as defined by CR, PR or SD for 6 months or greater unless
patient has de novo resistance to EGFR TKI (e.g. exon 20 insertions.)

- All patients must have at least one measurable lesion as defined by RECIST criteria.
Previously irradiated lesions are not measurable unless the lesion is new or has
demonstrated clear progression after radiation

- World Health Organization (WHO) performance status ≤ 2. For patients enrolled to the
fifth stratum, modified EGFR mutant, World Health Organization (WHO) performance
status ≤ 1

- Patients enrolled to the fifth stratum, modified EGFR mutant, must be willing and
suitable to undergo fresh baseline biopsy prior to study treatment (unless patient
had recent biopsy after EGFR TKI progression that concluded resistance to EGFR TKI.)

- Hematologic:

- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L.

- Hemoglobin (Hgb) ≥ 9 g/dl.

- Platelets (plt) ≥ 100 x 109/L.

Biochemistry:

- Total calcium (corrected for serum albumin) within normal limits or correctable with
supplements.

- Magnesium within lower normal limits or correctable with supplements.

Adequate liver function defined as:

- AST/SGOT and ALT/SGPT ≤ 3.0 x Upper limit of Normal (ULN) or ≤ 5.0 x ULN if liver
metastasis are present.

- Serum bilirubin ≤ 1.5 x ULN.

- Serum albumin > 2.5 g/dL.

- Serum creatinine ≤ 1.5 x ULN or 24 hour clearance ≥ 50 mL/min.

Exclusion Criteria:

- Patients who have received more than four lines of prior treatment. Exception:
Patients enrolled to the fifth stratum, modified EGFR mutant, must not have received
more than two prior lines of therapy. Chemotherapy administered as adjuvant treatment
more than six months prior to study enrollment is not considered a prior line of
therapy for purposes of this study.

- Patients with a history of CNS metastasis. Note: Patients without clinical signs and
symptoms of CNS involvement are not required to have MRI of the brain. Exception:
Patients with treated brain metastases who are asymptomatic, who has discontinued
corticosteroids, and who have been clinically stable for one month will be eligible
for protocol participation. This exception is not valid for patients enrolled to the
fifth stratum, modified EGFR mutant. These patients must not have CNS involvement.

- Prior anti-neoplastic treatment with any HSP90 or HDAC inhibitor compound.

- Patients must not have received:

- any systemic anti-cancer treatment or radiotherapy within 4 weeks prior to first
dose of study treatment and should have recovered to baseline or less than Grade
1 from toxicities of such therapy prior to the first dose of study treatment

- 2 weeks for palliative radiotherapy to bones, 6 weeks for nitrosoureas and
mitomycin

- 4 weeks for monoclonal antibodies

- and ≤5 half-life of the agent or active metabolities [if any] for continuous
systemic anti-cancer treatment or investigational

- Patients who do not have either an archival tumor sample available or are unwilling
to have a fresh tumor sample collected at baseline.

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To estimate efficacy for each study strata at 18 weeks as assessed by RECIST.

Outcome Time Frame:

18 weeks

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CAUY922A2206

NCT ID:

NCT01124864

Start Date:

October 2010

Completion Date:

November 2014

Related Keywords:

  • Non-Small-Cell Lung Cancer
  • Non-small-cell lung cancer
  • HSP90
  • 2nd to 3rd line treatment
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Dana Farber Cancer Institute DFCIBoston, Massachusetts  02115
Associates in Oncology/Hematology, P.C. Dept. of Assoc. Onc/HemRockville, Maryland  20850
St. Luke's Hospital and Health Network St Luke'sBethlehem, Pennsylvania  
University of California at Los Angeles UCLA - Santa MonicaLos Angeles, California  90095