Vismodegib and Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced or Metastatic Sarcoma

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
RO4929097 10mg	RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
RO4929097 15 mg	RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
ARM 1 - RO4929097: 15 mg PO QD	ARM 1 - RO4929097: 15 mg PO QD
ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD	ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD

Participant Flow for 2 periods

Period 1:   Phase Ib

	RO4929097 10mg	RO4929097 15 mg	ARM 1 - RO4929097: 15 mg PO QD	ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
STARTED	6	4	0	0
COMPLETED	3	3	0	0
NOT COMPLETED	3	1	0	0
Not Treated	1	0	0	0
Adverse Event	2	1	0	0

Period 2:   Phase II

	RO4929097 10mg	RO4929097 15 mg	ARM 1 - RO4929097: 15 mg PO QD	ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
STARTED	0	0	35	33
COMPLETED	0	0	30	27
NOT COMPLETED	0	0	5	6
Withdrawal by Subject	0	0	1	2
Adverse Event	0	0	4	4

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
RO4929097 10mg	RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
RO4929097 15 mg	RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
ARM 1 - RO4929097: 15 mg PO QD	ARM 1 - RO4929097: 15 mg PO QD
ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD	ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
Total	Total of all reporting groups

Baseline Measures

	RO4929097 10mg	RO4929097 15 mg	ARM 1 - RO4929097: 15 mg PO QD	ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD	Total
Overall Participants Analyzed  [Units: Participants]	6	4	35	33	78
Age  [Units: Participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	6	3	25	27	61
>=65 years	0	1	10	6	17
Gender  [Units: Participants]
Female	2	2	15	15	34
Male	4	2	20	18	44
Region of Enrollment  [Units: Participants]
United States	6	4	35	33	78

1.  Primary:

Maximum-tolerated Dose of Gamma-secretase Inhibitor RO4929097, Defined as the Dose Level Where no More Than 1 Out of 6 Patients Experience DLT at the Highest Dose Level Below the MAD, Graded According to NCI-CTCAE Version 4.0 (Phase Ib)   [ Time Frame: Up to 28 days ]

2.  Secondary:

Response Rate (CR + PR) as Assessed by RECIST 1.1 (Phase Ib and II)   [ Time Frame: Up to 4 months ]

3.  Primary:

Progression-free Survival (PFS) of the Combination of RO4929097 With and Without GDC-0449 in Patients With Advanced Sarcoma. (Phase II)   [ Time Frame: 1 year ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Roche has discontinued further development of the Notch inhibitor (RO4929097) and this Phase II trial was prematurely closed.