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An Open-Label Phase I/II Study of GSK2110183 in Combination With Carboplatin and Paclitaxel in Subjects With Platinum-Resistant Ovarian Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Recurrent Platinum-resistant Ovarian Cancer

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Trial Information

An Open-Label Phase I/II Study of GSK2110183 in Combination With Carboplatin and Paclitaxel in Subjects With Platinum-Resistant Ovarian Cancer

PKB116611 is an open-label Phase I/II study of the investigational drug GSK2110183 given in
combination with carboplatin and paclitaxel to subjects with recurrent ovarian cancer.
Phase I is a dose escalation evaluation of daily oral doses of GSK2110183 administered in
combination with every 3 week carboplatin and paclitaxel to any subject with recurrent
ovarian cancer. Phase II is a single arm evaluation of the clinical efficacy of the
combination identified in Phase I to subjects with platinum-resistant ovarian cancer.

Phase I

Inclusion Criteria:

- Female, 18 years of age as of signing the informed consent form, capable of
giving/complying with written informed consent

- Histologically or cytologically confirmed serous ovarian cancer (includes primary
peritoneal and Fallopian tube)

- Negative serum pregnancy test in women of childbearing potential within 14 days of
first dose of treatment, agree to use effective contraception during/after (6 months
post dose of paclitaxel or 30 days post dose GSK2110183 whichever is longer)

- Performance Status score of 0-2 according to the ECOG scale.

- Able to swallow and retain oral medication

- Subjects diagnosed previously with Type 2 diabetes must have been diagnosed ≥ 6
months prior to enrollment

- Prior treatment-related toxicities (except for alopecia) must be ≤ Grade 1 according
to NCI-CTCAE (Version 4.0 [NCI, 2009]) at the time of treatment allocation OR ≤ Grade
2 and stable for 4 weeks or longer at the time of screening evaluation. Exception:
Subjects with peripheral neuropathy >/= Grade 2 will NOT be eligible

- Adequate organ system function

Phase II

Inclusion Criteria:

- Phase I criteria

- Documented complete or partial response by RECIST to at least 1 prior platinum-based

- Progression defined by either (1) RECIST v1.1 criteria or (2) GCIG CA 125 criteria
associated with symptoms necessitating treatment within 6 months of prior
platinum-based therapy either in adjuvant or metastatic setting

- Subjects will be required to start on treatment within 8 months after the last
platinum-based therapy and may not have had any other anti-cancer therapy in the
intervening time

- Must have radiologically measurable disease i.e. presenting with at least one
measurable lesion per RECIST 1.1

Exclusion Criteria:

- History of another malignancy (some exceptions may apply)

- Serious and/or unstable pre-existing medical or psychiatric disorder, or other
conditions that could interfere with subject's safety, obtaining informed consent or
compliance to the study procedures

- Current use of prohibited medication during treatment.

- Chemotherapy, immunotherapy, or other anti-cancer therapy within 14 days prior to the
first dose study drug

- Radiotherapy prior to initiation of therapy (some exceptions may apply)

- Contraindications (identified by the investigator) to the doses of carboplatin and/or

- History of reduction in standard of care paclitaxel dose for peripheral neuropathy

- No known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to
drugs similar or related to GSK2110183

- No known delayed hypersensitivity reaction or idiosyncratic reaction to drugs similar
to carboplatin or paclitaxel (some exceptions may apply)

- Prior use of a drug that targets AKT including perifosine

- History of Type 1 diabetes

- Gastrointestinal disease or other condition that could affect absorption or
predispose subject to gastrointestinal ulceration

- Mucosal or internal bleeding

- Major surgery within the last four weeks

- Infection requiring parenteral or oral anti-infective treatment

- Severe or uncontrolled systemic diseases

- Brain metastases and/or leptomeningeal disease

- QTcF interval ≥ 470 msecs

- Bundle branch block, pacemaker or clinically significant ECG abnormalities including
2nd degree (Type II) or 3rd degree atrioventricular (AV) block

- History of myocardial infarction, acute coronary syndromes (including unstable
angina), coronary angioplasty,stenting or bypass grafting within six months of

- Class II, III or IV heart failure as defined by the NYHA functional classification

- Pregnant or lactating female

- Malignancies related to HIV or solid organ transplant; history of known HIV, history
of know HBV surface antigen positivity (subjects with documented laboratory evidence
of HBV clearance may be enrolled) or positive HCV antibody

Type of Study:


Study Design:

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

Outcome Measure:

Phase I - Dose Escalation

Outcome Description:

Determine the safety and tolerability of GSK2110183 administered in combination with carboplatin and paclitaxel in subjects with recurrent ovarian cancer which will be used to identify the dosing regimen to be evaluated in Phase II. Endpoints: AEs, SAEs, dose reduction or delays, withdrawals due to toxicities and changes in laboratory values and vital signs.

Outcome Time Frame:

Every 3 weeks

Safety Issue:


Principal Investigator

Shannon R Morris, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:



Australia: Department of Health and Ageing Therapeutic Goods Administration (Part I and II)

Study ID:




Start Date:

December 2012

Completion Date:

September 2014

Related Keywords:

  • Recurrent Platinum-resistant Ovarian Cancer
  • cancer
  • ovarian
  • platinum-resistant
  • Ovarian Neoplasms