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A Phase II Study of SB-715992 (NSC-727990, IND-70273) in Advanced Renal Cell Cancer


Phase 2
N/A
N/A
Not Enrolling
Both
Recurrent Renal Cell Cancer, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer

Thank you

Trial Information

A Phase II Study of SB-715992 (NSC-727990, IND-70273) in Advanced Renal Cell Cancer


PRIMARY OBJECTIVES:

I. To assess the efficacy of SB-715992 in patients with advanced renal cell cancer who have
received at least one prior therapy. This will be achieved by a multi-center, single arm
phase II study to evaluate the proportion of patients who achieve a complete or partial
response with this agent.

SECONDARY OBJECTIVES:

I. To assess the overall survival. II. To assess the time to progression. III. To evaluate
the qualitative and quantitative toxicities of this regimen.

OUTLINE: This is a multicenter study.

Patients receive ispinesib (SB-715992) IV over 1 hour on days 1, 8, and 15. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 3 years.


Inclusion Criteria:



- Patients must have histologically or cytologically confirmed renal cell carcinoma
which is metastatic (M1); histopathology is not restricted; patients with
unresectable primary tumor (but MO) are also eligible

- Patients must have measurable disease; x-rays, scans or physical examinations used
for tumor measurement must have been completed within 28 days prior to registration;
x-rays, scans or physical examinations for non-measurable disease must have been
completed within 42 days prior to registration

- Patients with metastatic disease who have a resectable primary tumor and are deemed a
surgical candidate may have undergone resection and have recovered from surgery; at
least 28 days must have elapsed since surgery and patient must have recovered from
any adverse effects of surgery

- Patients must have discontinued therapy due to toxicity or demonstrated progression
of disease following a minimum of one prior therapy; prior therapies may include:
immunotherapy with either interferon (IFN) and/or Interleukin-2 (IL-2) or prior
anti-angiogenesis agents; at least 28 days must have elapsed since the last
treatment; patients must have recovered from any adverse effects of prior therapy

- Patients may have received prior radiation therapy; at least 21 days must have
elapsed since completion of prior radiation therapy; patients must have recovered
from all associated toxicities at the time of registration

- Patients may not have received prior tubule, DNA, or mitosis targeting agents for the
treatment of renal cell carcinoma

- Patients must have a ECOG performance status of 0 - 2

- Pregnant or nursing women may not participate in this trial; women and men of
reproductive potential must have agreed to use an effective contraceptive method;
women of child-bearing potential must have a negative urine pregnancy test

- Patients with a history of brain metastases or who currently have treated or
untreated brain metastases are not eligible; patients with clinical evidence of brain
metastases must have a brain CT or MRI negative for metastatic disease within 56 days
prior to registration

- Absolute granulocyte count (AGC) ≥ 1,500 cells/mm3, hemoglobin ≥ 9 mg/dl, and a
platelet count ≥ 100,000 cells/mm3 within 14 days prior to registration

- Patients must have a total bilirubin < 2 mg/dl obtained within 14 days prior to
registration

- Patients must have SGOT and SGPT =< 2.5 x institutional upper limit of normal within
14 days prior to registration

- Patients must have a serum creatinine =< 2.0 or a calculated creatinine clearance >=
40 mL/min for patients with creatinine levels above institutional normal; this must
be obtained within 14 days prior to registration

- Patients must have a corrected QT interval less than 0.47 seconds

- All patients must be informed of the investigational nature of this study and must
sign and give written informed consent in accordance with institutional and federal
guidelines

- Prohibited medications; SB-715992 is a moderate to significant in vitro inhibitor of
CYP3A4; the following lists of medications/substances are moderate to significant
inhibitors/inducers of CYP3A4 that, if administered concomitantly with SB-715992, may
alter study drug exposure; the use of these medications/ substances within 14 days
(=< 6 months for amiodarone) prior to the administration of the first dose of
SB-715992 through discontinuation from the study is prohibited

- Inhibitors of CYP3A4:

- Antibiotics: Clarithromycin, erythromycin, troleandomycin, rifabutin,
rifapentine

- Antifungals: itraconazole, ketoconazole, fluconazole (doses > 200 mg/day),
voriconazole

- Antidepressants: nefazodone, fluovoxamine

- Calcium channel blockers: verapamil, diltiazem

- Miscellaneous: amiodarone*, bitter orange

- Use of amiodarone within 6 months prior to the administration of the first dose
of SB-715992 is prohibited.

- Inducers of CYP3A4:

- Anticonvulsants: phenytoin, carbamazepine, phenobarbital, oxcarbazepine

- Antibiotics: rifampin, rifabutin, rifapentine

- Miscellaneous: St. John's Wort, modafinil

- Patients must not have a history of allergic reactions attributed to compounds of
similar chemical or biologic composition to SB-715992

- Patients must not have any 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 with study requirements

- Patients with immune deficiency are at increased risk of lethal infections when
treated with marrow-suppressive therapy; therefore, HIV-positive patients receiving
combination anti-retroviral therapy are not eligible because of possible
pharmacokinetic interactions with SB-715992

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from
which the patient is currently in complete remission, or any other cancer from which
the patient has been disease-free for 5 years

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate defined as the proportion of patients who achieve a complete or partial response with ispinesib evaluated per RECIST

Outcome Description:

If the response rate is 30% or more, further study would be proposed based on the estimates produced in this trial. Will be presented along with 95% confidence intervals.

Outcome Time Frame:

Up to 4 years

Safety Issue:

No

Principal Investigator

Walter Stadler

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02928

NCT ID:

NCT00354250

Start Date:

May 2006

Completion Date:

Related Keywords:

  • Recurrent Renal Cell Cancer
  • Stage III Renal Cell Cancer
  • Stage IV Renal Cell Cancer
  • Carcinoma, Renal Cell

Name

Location

University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470