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A Phase I Open-Label, Dose-Escalation Study of the Phosphoinositide 3-Kinase Inhibitor GSK1059615 in Patients With Solid Tumors or Lymphoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumours, Metastatic Breast Cancer, Solid Tumor Cancer, Lymphoma, Endometrial Cancer

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Trial Information

A Phase I Open-Label, Dose-Escalation Study of the Phosphoinositide 3-Kinase Inhibitor GSK1059615 in Patients With Solid Tumors or Lymphoma


Inclusion Criteria:



- Written informed consent provided.

- 18 years old or older.

- Histologically- or cytologically- confirmed diagnosis of solid tumor malignancy or
lymphoma that is not responsive to accepted standard therapies or for which there is
no standard or curative therapy.

- Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology
Group (ECOG) scale.

- A life expectancy of > 12 weeks.

- Able to swallow and retain oral medication.

- A male is eligible to enter and participate in the study if he either:

- agrees to abstain from sexual intercourse from the first dose of study drug and until
21 days after last dose of study medication, or

- agrees to use a condom and occlusive cap (diaphragm or cervical/vault cap) with
spermicidal foam/gel/film/cream/suppository from the first dose of study drug and
until 21 days after last dose of study medication, or

- is surgically sterile. NOTE: Male patients must use contraception to prevent
pregnancy in a female partner and prevent exposure of any partner to semen by any
means (refer to protocol).

- A female is eligible to enroll in the study if she is of:

Non-child bearing potential (i.e., physiologically incapable of becoming pregnant)
including any woman who is characterized by at least one of the following:

- Has had a hysterectomy

- Has had a bilateral oophorectomy (ovariectomy)

- Has had a bilateral tubal ligation

- Is post-menopausal (total cessation of menses for ≥ 1 year) Childbearing potential,
has a negative serum pregnancy test at screening, and agrees to one of the following
from at least 2 weeks prior to the first dose of study drug and until 21 days after
last dose of study medication:

- Use an intrauterine device (IUD) with a documented failure rate of

- less than 1% per year.

- Have intercourse only with a vasectomized partner who is sterile

- and is the sole sexual partner for that woman.

- Complete abstinence from sexual intercourse.

- Use double barrier contraception defined as condom with

- spermicidal jelly, foam, suppository, or film; OR diaphragm with

- spermicide; OR male condom and diaphragm. NOTE: Oral contraceptives are not reliable
due to potential for drug-drug interaction.

- Adequate organ system function as defined in the protocol.

Exclusion Criteria:

- Use of an investigational anti-cancer drug within 28 days or 5 half-lives preceding
the first dose of GSK1059615.

- Chemotherapy within the last 3 weeks (6 weeks for prior nitrosourea or mitomycin C).
Chemotherapy regimens given continuously or on a weekly basis with limited potential
for delayed toxicity are permitted with approval of the GSK medical monitor if
administered at least 2 weeks prior to the first dose of study drug.

- Trastuzumab within the last 4 weeks.

- Any major surgery, radiotherapy, or immunotherapy within the last 4 weeks.

- Prior use of any PI3K inhibitor.

- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to the study drug. (To date there are no known FDA approved drugs
chemically related to GSK1059615).

- Current use of a prohibited medication or requires any of these medications during
treatment with GSK1059615 as per protocol.

- Current use of warfarin for therapeutic anticoagulation.

- NOTE: Low molecular weight heparin and prophylactic low-dose warfarin are permitted.
PT/PTT must meet the inclusion criteria. Patients taking warfarin must have their INR
followed closely.

- Presence of an active gastrointestinal disease or other condition known to interfere
significantly with the absorption, distribution, metabolism, or excretion of drugs.

- Unresolved toxicity greater than Grade 1 from previous anti-cancer therapy except
alopecia. Patients with stable Grade 2 neuropathy can be enrolled with approval by
the GSK Medical Monitor.

- QTc interval ≥ 480 msecs.

- History of acute coronary syndromes (including unstable angina and myocardial
infarction), atrial fibrillation, coronary angioplasty, or stenting within the past
24 weeks.

- Class II, III, or IV heart failure as defined by the New York Heart Association
(NYHA) functional classification system.

- Symptomatic or untreated leptomeningeal or brain metastases. Patients previously
treated for these conditions who are asymptomatic and off of corticosteroid and
P450-inducing anti-epileptic medication for at least 2 months are permitted.

- Primary malignancy of the central nervous system.

- Psychological, familial, sociological, or geographical conditions that do not permit
compliance with the protocol.

- Concurrent condition that in the investigator's opinion would jeopardize compliance
with the protocol.

- Nursing female.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Adverse events (AEs) and changes in laboratory values and vital signs as per protocol.

Outcome Time Frame:

21 days

Safety Issue:

Yes

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

PIK111051

NCT ID:

NCT00695448

Start Date:

June 2008

Completion Date:

March 2009

Related Keywords:

  • Solid Tumours
  • Metastatic Breast Cancer
  • Solid Tumor Cancer
  • Lymphoma
  • Endometrial Cancer
  • Phosphoinositide 3-kinase inhibitor
  • solid tumors
  • Breast Neoplasms
  • Endometrial Neoplasms
  • Lymphoma
  • Adenoma
  • Neoplasms

Name

Location

GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteGermantown, Tennessee  38138