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Trial registered on ANZCTR


Registration number
ACTRN12616000331437
Ethics application status
Approved
Date submitted
20/01/2016
Date registered
15/03/2016
Date last updated
17/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
An observational research study to examine the usefulness of a test called FoundationOne (Registered Trademark) in providing some recommended treatment options for patients with cancer where the location of the cancer cannot yet be found.
Scientific title
A Prospective Observational Trial Evaluating Outcomes of FoundationOne (Registered Trademark)-Directed Matched Targeted Therapy in Patients with Cancer of Unknown Primary (CUP).
Secondary ID [1] 287921 0
RAP-CLT-15-010
Universal Trial Number (UTN)
Trial acronym
TEMPO study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer of Unknown Primary (CUP) 296806 0
Condition category
Condition code
Cancer 297035 297035 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a prospective, single arm observational study of FoundationOne (Registered Trademark) -directed targeted therapy in newly diagnosed and previously treated patients with CUP. Patients will be consented and have FoundationOne (Registered Trademark) comprehensive molecular profiling completed. Other molecular assays are permitted for treatment assignment, but adequate tumor tissue must remain to perform FoundationOne (Registered Trademark). FoundationOne (Registered Trademark) profiling is required as part of this study. If the FoundationOne (Registered Trademark) has not already been conducted, a tissue sample from the patient’s biopsy will be sent to Foundation Medicine for testing. Adequate tumor tissue must remain to confirm genomic alterations in enrolled patients. Results from the FoundationOne (Registered Trademark) may provide information about patients’ cancer that may help physicians make decisions about patients’ treatment. Previous FoundationOne (Registered Trademark) profiling is also allowed and is not required to be repeated. All patients will be followed approximately every 3 months until death.
Upon distribution of the results, physicians will decide with patients the appropriate treatment regimen. Patients may be treated on clinical trials of targeted therapies or may receive TGA approved therapies, including “off-label” agents, as available.
Intervention code [1] 293278 0
Diagnosis / Prognosis
Comparator / control treatment
There is no control group for study. The historical control group noted in the protocol will be used for comparison purposes in the final data analysis.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296634 0
The primary outcome of the study is to determine the utility of the FoundationOne(Registered Trademark) test, as measured by patients’ overall survival (OS). Utility of the FoundationOne(Registered Trademark) test will be assessed by review of medical records and comparison to historical OS data for patients who did not receive FoundationOne(Registered Trademark) testing.
Timepoint [1] 296634 0
Study patients will be assessed approximately every 3 months from enrolment to death due to any cause.
Secondary outcome [1] 318956 0
Overall response rate, defined as a partial response or complete response occurring at any point post treatment according to RECIST version 1.1, as assessed by review of medical records.
Timepoint [1] 318956 0
Assessed approximately every 3 months from enrolment to death due to any cause..

Eligibility
Key inclusion criteria
1. Histological or cytological confirmed diagnosis of metastatic or advanced unresectable CUP including adenocarcinoma, poorly differentiated adenocarcinoma, poorly differentiated carcinoma, or squamous carcinoma.
2. To be categorized as CUP, the following clinical evaluations must have been performed
without identification of an anatomic primary site: medical history, physical examination,
chemistry profile, blood counts, serum PSA (men), CT scans of chest/abdomen/pelvis,
specific evaluation of symptomatic areas.
3. Sufficient Formalin Fixed Paraffin Embedded tissue from cancer of unknown primary available for FoundationOne (Registered Trademark) testing.
4. First and second line patients must have an ECOG Status score of 0 to 2. Third line patients enrolling in this study must have an ECOG Status score of 0 to 1.
5. Measurable or evaluable disease per RECIST version 1.1
6. Patients are considered potential candidates for treatment with targeted therapy.
7. Willingness and ability to comply with study and follow-up procedures.
8. Ability to understand the nature of this study and give written informed consent.
9. Presence of other active cancers is not allowed, unless indolent and not requiring therapy. Patients with early stage cancer who have received definitive local treatment and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e., non-invasive) are eligible, as are patients with history of nonmelanoma skin cancer.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Received three or more lines of prior therapy for CUP.
2. Previously received matched targeted therapy for the same Class 1 alteration or the same drug.
3. Treatable CUP syndrome, including the following: a. extragonadal germ cell syndrome,
b. neuroendocrine carcinoma, c. adenocarcinoma isolated to axillary lymph nodes (women), d. peritoneal carcinomatosis (women), e. squamous cell carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes, and f. single resectable metastasis.
4. Previously untreated brain metastases. Patients who have received radiation or surgery or brain metastases are eligible if therapy was completed at least 2 weeks prior to study entry and there is no evidence of central nervous system disease progression, mild neurologic symptoms, and no requirement for chronic corticosteroid therapy.
5. Enzyme inducing anticonvulsants
6. Pregnant or lactating.
7. Psychological, familial, sociologic, or geographic conditions that do not permit compliance with the protocol.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The design of this trial assumes that approximately 25% of 500 enrolled patients will have genomic alterations identified as listed in the study protocol (Class 1, 2, and 3 alterations as defined at the time the patient was initiated on treatment) where targeted agents could be employed, and assumes approximately half of these patients will receive therapies.
Therefore, 63 patients are expected to receive matched targeted therapy. With 80% power and an alpha of .10, we would be able to demonstrate an Overall survival of 18 months in this subgroup of the enrolled population versus an estimated control of 12.5 months.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
8/02/2016
Date of last participant enrolment
Anticipated
13/02/2017
Actual
1/12/2016
Date of last data collection
Anticipated
1/12/2016
Actual
1/02/2017
Sample size
Target
500
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5270 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment postcode(s) [1] 12536 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 7337 0
United States of America
State/province [1] 7337 0

Funding & Sponsors
Funding source category [1] 292407 0
Commercial sector/Industry
Name [1] 292407 0
Foundation Medicine, Inc.
Country [1] 292407 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Foundation Medicine, Inc.
Address
150 Second Street
Cambridge, MA 02141
Country
United States of America
Secondary sponsor category [1] 291092 0
None
Name [1] 291092 0
Address [1] 291092 0
Country [1] 291092 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293873 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 293873 0
Ethics committee country [1] 293873 0
Australia
Date submitted for ethics approval [1] 293873 0
09/11/2015
Approval date [1] 293873 0
27/01/2016
Ethics approval number [1] 293873 0
HREC/15/PMCC/97

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

Contacts
Principal investigator
Name 61610 0
A/Prof Linda Mileshkin
Address 61610 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne
Victoria Australia 3002
Country 61610 0
Australia
Phone 61610 0
+61 3 9656 1697
Fax 61610 0
Email 61610 0
[email protected]
Contact person for public queries
Name 61611 0
Linda Mileshkin
Address 61611 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne
Victoria Australia 3002
Country 61611 0
Australia
Phone 61611 0
+61 3 9656 1697
Fax 61611 0
Email 61611 0
[email protected]
Contact person for scientific queries
Name 61612 0
Linda Mileshkin
Address 61612 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne
Victoria Australia 3002
Country 61612 0
Australia
Phone 61612 0
+61 3 9656 1697
Fax 61612 0
Email 61612 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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Documents added automatically
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