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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01493843




Registration number
NCT01493843
Ethics application status
Date submitted
14/12/2011
Date registered
16/12/2011
Date last updated
25/04/2017

Titles & IDs
Public title
Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without Pictilisib in Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer
Scientific title
A Phase II, Double-Blind, Placebo-Controlled, Randomized Study Evaluating the Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without GDC-0941 in Patients With Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer
Secondary ID [1] 0 0
2011-002893-21
Secondary ID [2] 0 0
GO27912
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - pictilisib
Treatment: Drugs - Placebo
Treatment: Drugs - bevacizumab
Treatment: Drugs - carboplatin
Treatment: Drugs - paclitaxel

Experimental: Arm A: 340 mg pictilisib + CP - Participants with advanced (Stage IV) or recurrent squamous NSCLC will be administered 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P).

Placebo Comparator: Arm B: Placebo + CP - Participants with advanced (Stage IV) or recurrent squamous NSCLC will be administered placebo corresponding to 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P). Participants with investigator assessed radiographic progression of NSCLC per RECIST 1.1 will be allowed to cross over to Arm A during the first 4 cycles with carboplatin + paclitaxel or after chemotherapy has been completed (Cycle >/= 5).

Experimental: Arm C: 340 mg pictilisib + CPB - Participants with advanced (Stage IV) or recurrent non-squamous NSCLC will be administered 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P) plus bevacizumab (B).

Placebo Comparator: Arm D: Placebo + CPB - Participants with advanced (Stage IV) or recurrent non-squamous NSCLC will be administered placebo corresponding to 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P). Participants with investigator assessed radiographic progression of NSCLC per RECIST 1.1 will be allowed to cross over to Arm C during the first 4 cycles with carboplatin + paclitaxel + bevacizumab or after chemotherapy has been completed (Cycle >/= 5).

Experimental: Arm E: 260 mg pictilisib + CPB - Participants with advanced (Stage IV) or recurrent non-squamous NSCLC will be administered 260 mg pictilisib plus carboplatin (C) plus paclitaxel (P) plus bevacizumab (B).

Placebo Comparator: Arm F: Placebo + CPB - Participants with advanced (Stage IV) or recurrent non-squamous NSCLC will be administered placebo corresponding to 260 mg pictilisib plus carboplatin (C) plus paclitaxel (P). Participants with investigator assessed radiographic progression of NSCLC per RECIST 1.1 will be allowed to cross over to Arm E during the first 4 cycles with carboplatin + paclitaxel + bevacizumab or after chemotherapy has been completed (Cycle >/= 5).


Treatment: Drugs: pictilisib
Pictilisib, 260 milligrams (mg) or 340 mg, will be taken orally once daily on Days 1-14 of a 21-day cycle for four cycles. Starting with Cycle 5, pictilisib will be taken once daily continuously.

Treatment: Drugs: Placebo
Placebo corresponding to 260 mg or 340 mg pictilisib will be taken orally once daily on Days 1-14 of a 21-day cycle for four cycles. Starting with Cycle 5, placebo will be taken once daily continuously.

Treatment: Drugs: bevacizumab
Bevacizumab, 15 milligrams per kilogram (mg/kg) will be administered intravenously (IV) at Day 1 of each 21-day cycle for a maximum of 34 cycles.

Treatment: Drugs: carboplatin
Carboplatin will be administered IV to achieve an initial target area under the concentration curve (AUC) of 6 milligrams per milliliter per minute (mg/mL per min) on Day 1 of each 21-day cycle for a maximum of four cycles.

Treatment: Drugs: paclitaxel
Paclitaxel will be administered at 200 milligrams per square meter (mg/m^2) IV on Day 1 of each 21-day cycle for a maximum of four cycles.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 2.5 years
Primary outcome [2] 0 0
PFS in Participants with Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (PIK3CA) Amplification
Timepoint [2] 0 0
Up to approximately 2.5 years
Primary outcome [3] 0 0
PFS in Participants with Phosphatase and Tensin Homolog (PTEN) Loss/Low
Timepoint [3] 0 0
Up to approximately 2.5 years
Secondary outcome [1] 0 0
Objective Tumor Response
Timepoint [1] 0 0
Up to approximately 2.5 years
Secondary outcome [2] 0 0
Objective Tumor Response in Participants with PIK3CA Amplification
Timepoint [2] 0 0
Up to approximately 2.5 years
Secondary outcome [3] 0 0
Objective Tumor Response in Participants with PTEN Loss/low
Timepoint [3] 0 0
Up to approximately 2.5 years
Secondary outcome [4] 0 0
Duration of Objective Response (DoR)
Timepoint [4] 0 0
Up to approximately 2.5 years
Secondary outcome [5] 0 0
DoR in Participants with PIK3CA Amplification
Timepoint [5] 0 0
Up to approximately 2.5 years
Secondary outcome [6] 0 0
DoR in Participants with PTEN Loss/low
Timepoint [6] 0 0
Up to approximately 2.5 years
Secondary outcome [7] 0 0
Overall Survival (OS)
Timepoint [7] 0 0
Up to approximately 2.5 years
Secondary outcome [8] 0 0
OS in Participants with PIK3CA Amplification
Timepoint [8] 0 0
Up to approximately 2.5 years
Secondary outcome [9] 0 0
OS in Participants with PTEN Loss/low
Timepoint [9] 0 0
Up to approximately 2.5 years
Secondary outcome [10] 0 0
Percentage of Participants with Adverse Events
Timepoint [10] 0 0
Up to approximately 4 years

Eligibility
Key inclusion criteria
- Histologically documented advanced (Stage IV) or recurrent squamous (Arms A and B) or
non-squamous (Arms C, D, E, and F) non-small cell lung cancer (NSCLC)

- Consent to the collection of an archival formalin-fixed paraffin-embedded (FFPE) block
or freshly cut unstained tumor slides from archival tumor tissue or a newly collected
tumor sample

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Disease that is measurable per Response Evaluation Criteria In Solid Tumors (RECIST)
v1.1

- Adequate hematologic and end organ function

- Use of two effective forms of contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- NSCLC with documented epidermal growth factor receptor (EGFR) mutation associated with
response to EGFR inhibitors or documented fusion gene involving anaplastic lymphoma
kinase (ALK) gene

- Prior therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors,
radiotherapy, immunotherapy, hormonal therapy, or investigational therapy) before Day
1 of Cycle 1 for the treatment of advanced (Stage IV) or recurrent NSCLC

- Known central nervous system (CNS) disease except for treated brain metastases

- Type I diabetes

- Type II diabetes requiring chronic therapy with insulin

- Any other diseases, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the participant at high risk for treatment
complications

- Medical conditions that would contraindicate bevacizumab therapy in non-squamous NSCLC
(Arms C, D, E, and F)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/03/2016
Sample size
Target
Accrual to date
Final
501
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital; Sydney Cancer Centre - Camperdown
Recruitment hospital [2] 0 0
St Vincent'S Hospital - Darlinghurst
Recruitment hospital [3] 0 0
Calvary Mater Newcastle; Medical Oncology - Waratah
Recruitment hospital [4] 0 0
Flinders Medical Centre; Medical Oncology - Bedford Park
Recruitment hospital [5] 0 0
Royal Hobart Hospital; Medical Oncology - Hobart
Recruitment hospital [6] 0 0
Footscray Hospital - Footscray
Recruitment hospital [7] 0 0
Royal Melbourne Hospital; Hematology and Medical Oncology - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
7000 - Hobart
Recruitment postcode(s) [6] 0 0
3011 - Footscray
Recruitment postcode(s) [7] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
Argentina
State/province [21] 0 0
Cordoba
Country [22] 0 0
Argentina
State/province [22] 0 0
La Plata
Country [23] 0 0
Argentina
State/province [23] 0 0
Santa Fe
Country [24] 0 0
Brazil
State/province [24] 0 0
BA
Country [25] 0 0
Brazil
State/province [25] 0 0
DF
Country [26] 0 0
Brazil
State/province [26] 0 0
RJ
Country [27] 0 0
Brazil
State/province [27] 0 0
RN
Country [28] 0 0
Brazil
State/province [28] 0 0
RS
Country [29] 0 0
Brazil
State/province [29] 0 0
SC
Country [30] 0 0
Brazil
State/province [30] 0 0
SP
Country [31] 0 0
Canada
State/province [31] 0 0
Quebec
Country [32] 0 0
Chile
State/province [32] 0 0
Santiago
Country [33] 0 0
Chile
State/province [33] 0 0
Temuco
Country [34] 0 0
Chile
State/province [34] 0 0
Viña del Mar
Country [35] 0 0
France
State/province [35] 0 0
Brest
Country [36] 0 0
France
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Le Mans
Country [37] 0 0
France
State/province [37] 0 0
Nantes
Country [38] 0 0
France
State/province [38] 0 0
Saint Herblain
Country [39] 0 0
France
State/province [39] 0 0
Villefranche-sur-Saone
Country [40] 0 0
France
State/province [40] 0 0
Villejuif
Country [41] 0 0
Germany
State/province [41] 0 0
Bad Berka
Country [42] 0 0
Germany
State/province [42] 0 0
Gauting
Country [43] 0 0
Germany
State/province [43] 0 0
Grosshansdorf
Country [44] 0 0
Germany
State/province [44] 0 0
Karlsruhe
Country [45] 0 0
Germany
State/province [45] 0 0
Mainz
Country [46] 0 0
Germany
State/province [46] 0 0
Regensburg
Country [47] 0 0
Germany
State/province [47] 0 0
Ulm
Country [48] 0 0
Germany
State/province [48] 0 0
Villingen-Schwenningen
Country [49] 0 0
Hungary
State/province [49] 0 0
Budapest
Country [50] 0 0
Hungary
State/province [50] 0 0
Edeleny
Country [51] 0 0
Hungary
State/province [51] 0 0
Farkasgyepu
Country [52] 0 0
Hungary
State/province [52] 0 0
Szombathely
Country [53] 0 0
Hungary
State/province [53] 0 0
Torokbalint
Country [54] 0 0
Hungary
State/province [54] 0 0
Zalaegerszeg
Country [55] 0 0
Israel
State/province [55] 0 0
Jerusalem
Country [56] 0 0
Israel
State/province [56] 0 0
Kfar-Saba
Country [57] 0 0
Israel
State/province [57] 0 0
Ramat Gan
Country [58] 0 0
Italy
State/province [58] 0 0
Emilia-Romagna
Country [59] 0 0
Italy
State/province [59] 0 0
Friuli-Venezia Giulia
Country [60] 0 0
Italy
State/province [60] 0 0
Lombardia
Country [61] 0 0
Italy
State/province [61] 0 0
Piemonte
Country [62] 0 0
Italy
State/province [62] 0 0
Veneto
Country [63] 0 0
Netherlands
State/province [63] 0 0
Breda
Country [64] 0 0
Netherlands
State/province [64] 0 0
Eindhoven
Country [65] 0 0
Netherlands
State/province [65] 0 0
Groningen
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Chelyabinsk
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Moscow
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Nizhny Novgorod
Country [69] 0 0
Russian Federation
State/province [69] 0 0
St Petersburg
Country [70] 0 0
Russian Federation
State/province [70] 0 0
St. Petersburg
Country [71] 0 0
Spain
State/province [71] 0 0
Avila
Country [72] 0 0
Spain
State/province [72] 0 0
Barcelona
Country [73] 0 0
Spain
State/province [73] 0 0
Madrid
Country [74] 0 0
Ukraine
State/province [74] 0 0
Kiev
Country [75] 0 0
Ukraine
State/province [75] 0 0
Lutsk
Country [76] 0 0
Ukraine
State/province [76] 0 0
Lviv
Country [77] 0 0
Ukraine
State/province [77] 0 0
Simferopol
Country [78] 0 0
Ukraine
State/province [78] 0 0
Sumy
Country [79] 0 0
Ukraine
State/province [79] 0 0
Zaporizhzhya
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Guildford
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Leicester
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This multicenter, randomized, double-blind, placebo-controlled trial will evaluate the
efficacy and safety of carboplatin/paclitaxel and carboplatin/paclitaxel/bevacizumab with and
without pictilisib in particpants with previously untreated advanced or recurrent non-small
cell lung cancer (NSCLC). Particpants will be randomized to receive 4 cycles of carboplatin
(C)/paclitaxel (P) and either pictilisib or placebo, with (participants with non-squamous
NSCLC) or without (participants with squamous NSCLC) bevacizumab (B). Anticipated time on
study treatment is until disease progression or intolerable toxicity occurs. Participants in
placebo arms with disease progression may cross over to open-label active pictilisib.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01493843
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01493843