Multiple myeloma, other heamatologic malignancies, solid tumors MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Afuresertib
Product Code: GSK2110183
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Afuresertib
CAS Number: 1047645-82-8
Current Sponsor code: GSK2110183
Other descriptive name:
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Has provided signed informed consent for this study. 2. Is currently participating in an afuresertib study (monotherapy or in combination with another anti-cancer agent) sponsored by GSK or by another research organization working on behalf of GSK. 3. Currently tolerating and benefitting from treatment with afuresertib as determined by the investigator following previous treatment with afuresertib either as monotherapy or as part of a combination treatment regimen. 4. Continued ability to swallow and retain orally administered study treatment(s) and does not have any clinically significant GI abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels. 5. Male subjects with a female partner of childbearing potential must be willing to continue practicing the same acceptable method of contraception as used in the parent study and for at least 16 weeks after the last dose of afuresertib. 6. Female subjects of childbearing potential, as defined in the parent study, must be willing to continue practicing the same acceptable method of contraception as used in the parent study and for at least 4 weeks after the last dose of afuresertib. 7. Female subjects of childbearing potential, as defined in parent study, must have negative serum pregnancy tests at the time of transition to this study. 8. Maintain a performance status score of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) scale (Section 5.7) at time of transition into this study. 9. Subjects with Type II diabetes are only allowed if their HbA1C = 8% at study entry. 10. Have adequate organ system function as defined in Table 1 (Refer to Protocol version 03 – page 28). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1. Permanent discontinuation of afuresertib in the parent study due to toxicity or disease progression. 2. Concomitant use of any type of anti-cancer treatment other than studied in the parent protocol. 3. Current use of a prohibitive medication(s) as listed in Section 6.2. 4. Current use of anticoagulants is only allowed if PTT/INR values fulfil entry criteria. 5. Any unresolved toxicity > Grade 2 , except for alopecia, (National Cancer Institute-Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 4.0) from parent study treatment at the time of transition to this study. 6. History of HIV infection. 7. History of hepatitis B or C infection (subjects with evidence of cleared hepatitis B are permitted). 8. Evidence of severe or uncontrolled systemic diseases (e.g., unstable, or uncompensated respiratory, hepatic, renal, metabolic or cardiac disease). 9. QTcF interval > 500 msecs at the time of transition to this study. 10. Other clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block. 11. Evidence of current Class III, or IV heart failure as defined by the New York Heart Association [NYHA, 1994] functional classification system at the time of transition to this study. 12. Symptomatic or untreated leptomeningeal, CNS or brain metastases or spinal cord compression at the time of transition to this study. NOTE: Subjects are not permitted to receive enzyme-inducing anti-epileptic drugs (EIAEDs). Continued stability of brain metastases must be confirmed with imaging. 13. Lactating female or female who becomes pregnant prior to transition to this study. 14. Previously diagnosed diabetes mellitus Type I. Subjects with Type II diabetes are allowed if entry criteria are fulfilled (see entry criteria #9). 15. Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject’s safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or GSK Medical Monitor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to provide treatment with afuresertib for subjects who have previously participated in an afuresertib study sponsored by GSK or another research organization working on behalf of GSK.;Secondary Objective: The secondary objective of the study is to collect safety data on continued treatment with afuresertib.;Primary end point(s): Duration of afuresertib treatment in the study will be recorded;Timepoint(s) of evaluation of this end point: Disease status will be assessed at least every 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): This study will collect additional safety data from prolonged exposure to afuresertib, as monotherapy or in combination with other therapies. Primary endpoints for the study will be: adverse events, changes in laboratory values, and changes in vital signs.;Timepoint(s) of evaluation of this end point: Evaluation of endpoints to occur every 3 or 4 weeks during the first 52 weeks of study treatment and every 8 or 9 weeks after the 52 weeks of study treatment. Safety assessments will be performed throughout the study: including physical examinations, vital sign measurements (blood pressure [BP], pulse rate, weight and temperature), 12-lead electrocardiograms (ECGs), clinical laboratory assessments, and monitoring of AEs. Additional safety assessments may be necessary if a combination treatment regimen is administered to address specific safety concerns with the other agent(s). | — |
Countries
Australia, Canada, Ireland, Korea, Republic of, United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma Services AG
Outcome results
None listed