Study: NCT01792310

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LAM561
Description: Patients will receive treatment cycles of 21 days, until any criterion for discontinuation (clinical or radiological progression of disease, clinically unacceptable toxicity, or another general discontinuation criterion) is met.~Patients are expected to receive between one and 6 cycles of treatment. The treatment period may be extended if clinical benefit is shown.~In the event of significant GI toxicity, the treatment schedule may be modified from continuous dosing to an intermittent regime In the case of toxicity, the dose of LAM561 may be reduced or delayed by up to 14 days at the discretion of the Investigator. A maximum of two dose reductions will be permitted per patient. Treatment holidays of no more than 14 days are also permitted for reasons other than toxicity. Intra-patient dose escalation may be permitted in certain specific circumstances.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LAM561
Description: Patients will receive treatment cycles of 21 days, until any criterion for discontinuation (clinical or radiological progression of disease, clinically unacceptable toxicity, or another general discontinuation criterion) is met.~Patients are expected to receive between one and 6 cycles of treatment. The treatment period may be extended if clinical benefit is shown.~In the event of significant GI toxicity, the treatment schedule may be modified from continuous dosing to an intermittent regime In the case of toxicity, the dose of LAM561 may be reduced or delayed by up to 14 days at the discretion of the Investigator. A maximum of two dose reductions will be permitted per patient. Treatment holidays of no more than 14 days are also permitted for reasons other than toxicity. Intra-patient dose escalation may be permitted in certain specific circumstances.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LAM561
Description: Patients will receive treatment cycles of 21 days, until any criterion for discontinuation (clinical or radiological progression of disease, clinically unacceptable toxicity, or another general discontinuation criterion) is met.~Patients are expected to receive between one and 6 cycles of treatment. The treatment period may be extended if clinical benefit is shown.~In the event of significant GI toxicity, the treatment schedule may be modified from continuous dosing to an intermittent regime In the case of toxicity, the dose of LAM561 may be reduced or delayed by up to 14 days at the discretion of the Investigator. A maximum of two dose reductions will be permitted per patient. Treatment holidays of no more than 14 days are also permitted for reasons other than toxicity. Intra-patient dose escalation may be permitted in certain specific circumstances.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LAM561
Description: Patients will receive treatment cycles of 21 days, until any criterion for discontinuation (clinical or radiological progression of disease, clinically unacceptable toxicity, or another general discontinuation criterion) is met.~Patients are expected to receive between one and 6 cycles of treatment. The treatment period may be extended if clinical benefit is shown.~In the event of significant GI toxicity, the treatment schedule may be modified from continuous dosing to an intermittent regime In the case of toxicity, the dose of LAM561 may be reduced or delayed by up to 14 days at the discretion of the Investigator. A maximum of two dose reductions will be permitted per patient. Treatment holidays of no more than 14 days are also permitted for reasons other than toxicity. Intra-patient dose escalation may be permitted in certain specific circumstances.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LAM561
Description: Patients will receive treatment cycles of 21 days, until any criterion for discontinuation (clinical or radiological progression of disease, clinically unacceptable toxicity, or another general discontinuation criterion) is met.~Patients are expected to receive between one and 6 cycles of treatment. The treatment period may be extended if clinical benefit is shown.~In the event of significant GI toxicity, the treatment schedule may be modified from continuous dosing to an intermittent regime In the case of toxicity, the dose of LAM561 may be reduced or delayed by up to 14 days at the discretion of the Investigator. A maximum of two dose reductions will be permitted per patient. Treatment holidays of no more than 14 days are also permitted for reasons other than toxicity. Intra-patient dose escalation may be permitted in certain specific circumstances.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LAM561
Description: Patients will receive treatment cycles of 21 days, until any criterion for discontinuation (clinical or radiological progression of disease, clinically unacceptable toxicity, or another general discontinuation criterion) is met.~Patients are expected to receive between one and 6 cycles of treatment. The treatment period may be extended if clinical benefit is shown.~In the event of significant GI toxicity, the treatment schedule may be modified from continuous dosing to an intermittent regime In the case of toxicity, the dose of LAM561 may be reduced or delayed by up to 14 days at the discretion of the Investigator. A maximum of two dose reductions will be permitted per patient. Treatment holidays of no more than 14 days are also permitted for reasons other than toxicity. Intra-patient dose escalation may be permitted in certain specific circumstances.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LAM561
Description: Patients will receive treatment cycles of 21 days, until any criterion for discontinuation (clinical or radiological progression of disease, clinically unacceptable toxicity, or another general discontinuation criterion) is met.~Patients are expected to receive between one and 6 cycles of treatment. The treatment period may be extended if clinical benefit is shown.~In the event of significant GI toxicity, the treatment schedule may be modified from continuous dosing to an intermittent regime In the case of toxicity, the dose of LAM561 may be reduced or delayed by up to 14 days at the discretion of the Investigator. A maximum of two dose reductions will be permitted per patient. Treatment holidays of no more than 14 days are also permitted for reasons other than toxicity. Intra-patient dose escalation may be permitted in certain specific circumstances.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LAM561
Description: Patients will receive treatment cycles of 21 days, until any criterion for discontinuation (clinical or radiological progression of disease, clinically unacceptable toxicity, or another general discontinuation criterion) is met.~Patients are expected to receive between one and 6 cycles of treatment. The treatment period may be extended if clinical benefit is shown.~In the event of significant GI toxicity, the treatment schedule may be modified from continuous dosing to an intermittent regime In the case of toxicity, the dose of LAM561 may be reduced or delayed by up to 14 days at the discretion of the Investigator. A maximum of two dose reductions will be permitted per patient. Treatment holidays of no more than 14 days are also permitted for reasons other than toxicity. Intra-patient dose escalation may be permitted in certain specific circumstances.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LAM561
Description: Patients will receive treatment cycles of 21 days, until any criterion for discontinuation (clinical or radiological progression of disease, clinically unacceptable toxicity, or another general discontinuation criterion) is met.~Patients are expected to receive between one and 6 cycles of treatment. The treatment period may be extended if clinical benefit is shown.~In the event of significant GI toxicity, the treatment schedule may be modified from continuous dosing to an intermittent regime In the case of toxicity, the dose of LAM561 may be reduced or delayed by up to 14 days at the discretion of the Investigator. A maximum of two dose reductions will be permitted per patient. Treatment holidays of no more than 14 days are also permitted for reasons other than toxicity. Intra-patient dose escalation may be permitted in certain specific circumstances.