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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00889382




Registration number
NCT00889382
Ethics application status
Date submitted
6/04/2009
Date registered
28/04/2009

Titles & IDs
Public title
A Study Evaluating Intermittent and Continuous OSI-906 and Weekly Paclitaxel in Patients With Recurrent Epithelial Ovarian Cancer (and Other Solid Tumors)
Scientific title
A Phase 1/2 Study Evaluating Intermittent and Continuous OSI-906 and Weekly Paclitaxel in Patients With Recurrent Epithelial Ovarian Cancer (and Other Solid Tumors)
Secondary ID [1] 0 0
2009-010319-34
Secondary ID [2] 0 0
OSI-906-202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Solid Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - OSI-906
Treatment: Drugs - Paclitaxel

Experimental: Phase 1 Arm A - Intermittent OSI-906 Once Daily (QD) on Days 1 - 3, 8 - 10, and 15 - 17 with paclitaxel on Days 1, 8, and 15 (except Treatment Period 1 (TP 1); in TP 1 OSI-906 on Days 1 - 3, 8 - 10, 15 - 17, and 22 - 24 with paclitaxel on Days 8, 15, and 22)

Experimental: Phase 1 Arm B1 - Continuous OSI-906 Twice Daily (BID) (Days 1 - 21) with paclitaxel dosing on Days 1, 8, and 15;(except TP 1; in TP 1 OSI-906 on Days 1 - 3, 8 - 10, 15 - 17, and 22 - 24 with paclitaxel on Days 8, 15 and 22)

Experimental: Phase 1 Arm B2 - Continuous OSI-906 BID (Days 1 - 21) with paclitaxel dosing on Days 1, 8, and 15 (except TP 1; in TP 1 OSI-906 on Days 1 - 3, 8 - 10, 5 - 17, and 22 - 24 with paclitaxel on Days 8, 15, and 22); (additional PK sampling on Days 9 or 13 0r 14 for TP 1)

Experimental: Phase 1 Arm B3 - Continuous OSI-906 BID (Days 1 - 21) with paclitaxel dosing on Days 1, 8, and 15 with no separation in OSI-906 and paclitaxel dosing (except TP 1; in TP 1 continuous OSI-906 dosing 2 hours prior to the initiation of paclitaxel infusion on Day 8 only, with paclitaxel on Days 8, 15, and 22, and additional PK sampling on Day 9 or 13 or 14)

Experimental: Phase 2 Arm A - Intermittent OSI-906 QD on Days 1 - 3, 8 - 10, and 15 - 17 with paclitaxel on Days 1, 8, and 15

Experimental: Phase 2 Arm B - Continuous OSI-906 BID from Day 1 onwards with paclitaxel on Days 1, 8, and 15

Experimental: Phase 2 Arm C - Paclitaxel on Days 1, 8, and 15

Experimental: Phase 2 Arm C Roll-over - Continuous OSI-906 BID from Day 1 onwards


Treatment: Drugs: OSI-906
Administered orally

Treatment: Drugs: Paclitaxel
Administered intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Determine Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
Timepoint [1] 0 0
28 days
Primary outcome [2] 0 0
Progression Free Survival (PFS)
Timepoint [2] 0 0
36 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
Cancer Antigen 125 (CA125) Response Rate
Timepoint [2] 0 0
36 months
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
Duration of CA-125 Response (CA-125 DOR)
Timepoint [4] 0 0
36 months
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
36 months
Secondary outcome [6] 0 0
Safety assessed via physician exam, vital signs, clinical laboratory tests, electrocardiograms (ECG), and adverse events
Timepoint [6] 0 0
36 months

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed epithelial ovarian carcinoma Patients with fallopian or peritoneal cancer will also be eligible
* Patients with any solid tumor that may be treated with weekly paclitaxel will be eligible for the phase 1 portion
* For the phase 2 portion, patients must have elevated CA125 levels evaluable/assessable according to Gynecological Cancer Intergroup (GCIG) criteria (ie, > 70 U/mL) documented by 2 measurements at least 1 week apart
* Patients must have radiologically confirmed progressive disease by RECIST v1.1 criteria within 6 months prior to randomization. (patients must have measurable disease according to RECIST v1.1)
* Eastern Cooperative Oncology Group (ECOG) performance status(PS) 0 -1
* Predicted life expectancy = 12 weeks
* Patients may have had prior therapy, providing the following conditions are met:

* Chemotherapy: Prior chemotherapy must have been completed at least 3 weeks prior to study enrollment (6 weeks for mitomycin C, nitrosoureas or high-dose carboplatin [= 600 mg/m²]and 4 weeks for investigational drugs

1. Patient should have recovered from any drug-related toxicities (with the exception of grade 1 neuropathy and or alopecia)
2. Phase 1: While there is no limit on the number of prior regimens for patients entered into the phase 1 portion, any prior taxane therapy must have been administered on a 3 week schedule
3. Phase 2: Patients must have received prior chemotherapy, which must have contained a platinum and a taxanes at some point. Any prior taxanes therapy must have been administered on a 3 week schedule. A maximum of 2 prior chemotherapy regimens are permitted. Patients must be refractory radiologically confirmed by computerized tomography (CT) scan progressive disease (PD) during chemotherapy) or resistant (radiologically confirmed by CT scan PD within six months of completing chemotherapy) to their last platinum-containing chemotherapy regimen
* Radiation: Patients may have had prior radiation therapy provided they have recovered from the acute, toxic effects of radiotherapy prior to registration/randomization. Radiated lesions cannot be chosen as the target lesions

a. A minimum of 21 days must have elapsed between the end of radiotherapy and registration/randomization into the study unless the radiation affected less than 25% of bone marrow
* Surgery: Previous surgery is permitted provided that adequate wound healing has occurred prior to registration/randomization
* Fasting glucose = 150 mg/dL (8.3 mmol/L)
* Adequate hematopoietic, hepatic, and renal function defined as follows:

* Neutrophil count = 1.5 x 10 ^9 /L and platelet count > = 100 x 10^9/L;
* Bilirubin = 1.5 x Upper Limit of Normal (ULN);
* AST and/or ALT = 2.5 x ULN or < = 5 x ULN if patient has documented liver metastases; and
* Serum creatinine = 1.5 x ULN
* Female patient must be either:

* Of non childbearing potential:

1. post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
2. documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening)
* Or, if of childbearing potential:

1. must have a negative urine pregnancy test at Screening, and
2. must use two forms of birth control (one of which must be a barrier method) starting at Screening and throughout the study period and for 28 days [or 5 half lives, whichever is longer] after final study drug administration
* Female patient must not be breastfeeding at Screening or during the study period and for 28 days [or 5 half lives of the study drug whichever is longer] after final study drug administration
* Female patient must not donate ova starting at Screening and throughout the study period and for 28 days [or 5 half lives of the study drug whichever is longer] after final study drug administration
* Patients must provide verbal and written informed consent to participate in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diabetes mellitus currently requiring medication (eg, insulin or oral hypoglycemics)
* During the phase 2 portion, patients with histology of abdominal adenocarcinoma of unknown origin or a diagnosis of a borderline ovarian tumor
* Previous or concurrent malignancies (excluding curatively treated basal or squamous cell carcinoma of the skin or cervical carcinoma in situ) unless the patient has been in remission for at least 3 years
* History of significant cardiovascular disease unless the disease is well-controlled. Significant cardiac diseases includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea)
* History of cerebrovascular accident (CVA) within 6 months prior to registration/randomization or that is not stable
* Prior therapy with an insulin-like growth factor (IGF-1R) inhibitor
* Use of drugs that have a risk of causing QT interval prolongation within 14 days prior to Day 1 dosing
* Known or prior hypersensitivity to taxanes in spite of premedication or drugs containing Cremophor
* Gastro-intestinal abnormalities, including bowel obstruction, inability to take oral medication, requirement for intravenous (IV) alimentation,active peptic ulcer or prior surgical procedures or bowel resection affecting absorption
* Active infection or serious underlying medical condition (including any type of active seizure disorder within 12 months prior to registration/randomization) that would impair the ability of the patient to receive protocol treatment
* History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent
* Pregnancy or breast-feeding
* Symptomatic brain metastases that are not stable, require steroids, are potentially life threatening, or that have required radiation within 28 days prior to registration/randomization
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug
* History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) that is symptomatic or requires treatment (= grade 3), left bundle branch block (LBBB), or asymptomatic sustained ventricular tachycardia are not allowed. Patients with atrial fibrillation controlled by medication are not excluded. Patients with mean QTcF interval = 450 msec at screening are excluded
* Use of drugs that have a known risk of causing Torsade de Pointes (TdP) or that that have a risk of causing QT interval prolongation within 14 days prior to Day 1 dosing are prohibited
* Use of the potent CYP1A2 inhibitors ciprofloxacin and fluvoxamine. Other less potent CYP1A2 inhibitors/inducers are not excluded
* Participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives whichever is longer, prior to the initiation of Screening or during the course of the study

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
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
5/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/08/2014
Sample size
Target
Accrual to date
Final
152
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
WestMead Hospital - WestMead
Recruitment hospital [2] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - North Terrace
Recruitment hospital [4] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [5] 0 0
Frankston Hospital - Frankston
Recruitment hospital [6] 0 0
Border Medical Oncology - Wodonga
Recruitment hospital [7] 0 0
St. John of God Hospital, Bunbury - Bunbury
Recruitment hospital [8] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment hospital [9] 0 0
St. John of Gog Hospital, Subiaco - Subiaco
Recruitment postcode(s) [1] 0 0
2145 - WestMead
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
5000 - North Terrace
Recruitment postcode(s) [4] 0 0
7250 - Launceston
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
3690 - Wodonga
Recruitment postcode(s) [7] 0 0
6230 - Bunbury
Recruitment postcode(s) [8] 0 0
6009 - Perth
Recruitment postcode(s) [9] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Czechia
State/province [10] 0 0
Kralove
Country [11] 0 0
Czechia
State/province [11] 0 0
Ostrava- Poruba
Country [12] 0 0
Czechia
State/province [12] 0 0
Prague
Country [13] 0 0
Italy
State/province [13] 0 0
Bologna
Country [14] 0 0
Italy
State/province [14] 0 0
Carpi
Country [15] 0 0
Italy
State/province [15] 0 0
Milan
Country [16] 0 0
Italy
State/province [16] 0 0
Roma
Country [17] 0 0
Poland
State/province [17] 0 0
Lublin
Country [18] 0 0
Poland
State/province [18] 0 0
Poznan
Country [19] 0 0
Romania
State/province [19] 0 0
Cluj Napoca
Country [20] 0 0
Romania
State/province [20] 0 0
Iasi
Country [21] 0 0
Romania
State/province [21] 0 0
Mures
Country [22] 0 0
Russian Federation
State/province [22] 0 0
Moscow
Country [23] 0 0
Russian Federation
State/province [23] 0 0
Obninsk
Country [24] 0 0
Russian Federation
State/province [24] 0 0
St. Petersburg
Country [25] 0 0
Switzerland
State/province [25] 0 0
Bellinzona
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Surrey
Country [27] 0 0
United Kingdom
State/province [27] 0 0
London
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Manchester
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Northwood
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Oxford
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Withington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astellas Pharma Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Principal Investigator - Czech Republic
Address 0 0
General Faculty Hospital, Charles University
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Available to whom?
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicaltrials.astellas.com/transparency/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00889382