| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
Multiple myeloma, other heamatologic malignancies, solid tumors
|
|
| E.1.1.1 | Medical condition in easily understood language |
| Solid Tumors and Hematologic Malignancies |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | SOC |
| E.1.2 | Classification code | 10029104 |
| E.1.2 | Term | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| E.1.3 | Condition being studied is a rare disease | Yes |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| 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. |
|
| E.2.2 | Secondary objectives of the trial |
| The secondary objective of the study is to collect safety data on continued treatment with afuresertib. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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).
|
|
| E.4 | Principal 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.
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|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Duration of afuresertib treatment in the study will be recorded |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Disease status will be assessed at least every 12 weeks |
|
| E.5.2 | 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. |
|
| E.5.2.1 | 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).
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | No |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 1 |
| E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.5.1 | Number of sites anticipated in the EEA | 1 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Australia |
| Canada |
| Korea, Republic of |
| United States |
|
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| Study will be completed when the last subject has withdrawn from study treatment. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 3 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 3 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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