Unknown Primary TumorsPhase 2AGNOSTOSNCT02607202
A Study of Nab-paclitaxel-based Doublet as First Line Therapy in Patients With Cancer of Unknown Primary (CUP)
A Phase 2 study testing nab-paclitaxel, Carboplatin and Gemcitabine in people with Unknown Primary Tumors, run by Fondazione del Piemonte per l'Oncologia at 10 sites in Italy.
Trial summary
Agnostos Trial is a multicentric phase 2 randomized trial with a 'pick-the-winner design' in chemonaive patients with cancer of unknown primary. It will assess the efficacy of the two best active single agent - carboplatin or gemcitabine - added to an innovative taxane back bone (nab-Paclitaxel). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unknown Primary Tumors
- What is being tested?
- nab-paclitaxel, Carboplatin and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 10 sitesItaly
- Study dates
- Mar 2015to 31 Jan 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written informed consent.
- Patients must be ≥ 18 years of age.
- Diagnosis of CUP according to CUP Diagnostic Guidelines derived from ESMO 2011 and NCCN 2015 guidelines.
- Sufficient archived biopsy tissue from a surgical or core needle biopsy required to perform the CUP multiplex assay.
- Eastern Cooperative Oncology Group performance status ≤ 2.
- No previous systemic therapy.
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- At least one measurable lesion by RECIST Criteria.
- Good liver, cardiac, lung and marrow bone function.
- Evidence of non-childbearing status for female patients: negative urine or serum pregnancy test within 21 days of study treatment for women of childbearing potential, or postmenopausal status.
- Patients of child bearing potential and their partners, who are sexually active, must agree to the use of highly effective forms of contraception throughout their participation in the study.
- Patient is willing and able to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations.
Who cannot join
- Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, breast Ductal Carcinoma in Situ (DCIS), stage 1 grade 1 endometrial carcinoma.
- Specific treatable CUP syndromes including: extragonadal germ cell syndrome; neuroendocrine carcinoma; adenocarcinoma isolated to axillary lymph nodes (women cancer); peritoneal carcinomatosis (women - ovarian cancer); squamous carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes; single resectable metastasis.
- Patients receiving any radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry.
- Patients with symptomatic uncontrolled brain metastases.
- Major surgery within 2 weeks of starting the study and patients must have recovered from any effects of any major surgery.
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 6 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
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- Pregnant or breast feeding women.
- Immunocompromised patients, eg, patients who are known to be serologically positive for human immunodeficiency virus (HIV).
- Patients with known hepatic disease (eg, Hepatitis B or C).
- Previous cancer treatment.
- Patients currently enrolled in another clinical tria, except AGNOSTOS PROFILING.
- Patients that are receiving chemotherapy, hormonal therapy (HRT is acceptable) or other novel agents.
- Patients receiving live virus and bacterial vaccines.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites
AOU Policlinoco S Orsola - Malpighi
Bologna
Investigative Clinical Oncology (Oncologia Medica 2)
Candiolo, Turin, 10060
Ospedali Galliera
Genova
Istituto Europeo di Oncologia - IEO
Milan
Istituto Nazionale dei Tumori
Milan
Ospedale Niguarda Cà Granda
Milan
Istituto Oncologico Veneto - IOV
Padova
Fondazione IRCCS Policlinico San Matteo
Pavia
Policlinico Universitario Campus Biomedico
Roma
A.O.U S.Giovanni Battista
Torino, 10126
About this study
Official title: A Phase II, Randomized, Multicenter Study to Assess the Efficacy of Nab-paclitaxel-based Doublet as First Line Therapy in Patients With Cancer of Unknown Primary (CUP): The AGNOSTOS Trial
Agnostos Trial is a multicentric phase 2 randomized trial with a 'pick-the-winner design' in chemonaive patients with cancer of unknown primary. It will assess the efficacy of the two best active single agent - carboplatin or gemcitabine - added to an innovative taxane back bone (nab-Paclitaxel). Agnostos trial is a part of a larger clinical and translational initiative to improve the outlook of patients with cancer of unknown primary through evaluation of novel chemotherapeutic regimens.
Read the detailed description
Treatment-naïve patients with CUP diagnosis confirmed according to CUP Diagnostic Guidelines, will be enrolled into AGNOSTOS trial. Patients will be randomized upfront to receive a nab-paclitaxel-based duplet adding either carboplatin or gemcitabine until progression or unacceptable toxicity (randomization 1:1, n= 120; 60 per arm).
- Conditions
- Unknown Primary Tumors
- Being tested
- nab-paclitaxel, Carboplatin, Gemcitabine
- Medical subject headings
- Neoplasms, Unknown Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nab-paclitaxelDrug
Also called Abraxane
CarboplatinDrug
GemcitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | nab-paclitaxel 125 mg/m2 on Days 1 and 8 by IV administration over 30 minutes without premedication, followed by gemcitabine 1000 mg/m2 on Days 1 and 8 by IV administration over 30 minutes. Treatment to be repeated Q21 days. Receives: Drug: nab-paclitaxel; Drug: Gemcitabine |
| Arm B | Experimental | nab-paclitaxel 125 mg/m2 on Days 1 and 8 by IV administration over 30 minutes without premedication, followed by carboplatin AUC 2 on Day 1 and 8 by IV administration over 60 minutes. Treatment to be repeated Q21 days. Receives: Drug: nab-paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) as evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.
Measured: 42 months
Secondary outcomes (4)
duration of response according to RECIST version 1.1.
Measured: 42 months
time to progression
Measured: 42 months
overall survival
Measured: 42 months
toxicity according to Common Terminology Criteria for Adverse Events - CTCAE version 4.03.
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startMar 2015
- Primary completion4 May 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unknown Primary TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607202
- Sponsor's protocol ID
- 008-IRCC-10IIS-14
- Acronym
- AGNOSTOS
- Status last verified
- Jan 2024
- First submitted
- 16 Nov 2015
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Multicenter Study to Assess the Efficacy of Nab-paclitaxel-based Doublet as First Line Therapy in Patients With Cancer of Unknown Primary (CUP): The AGNOSTOS Trial
- ClinicalTrials.gov ID
- NCT02607202
- Acronym / sponsor ID
- AGNOSTOS / 008-IRCC-10IIS-14
- Conditions
- Unknown Primary Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Agnostos Trial is a multicentric phase 2 randomized trial with a 'pick-the-winner design' in chemonaive patients with cancer of unknown primary. It will assess the efficacy of the two best active single agent - carboplatin or gemcitabine - added to an innovative taxane back bone (nab-Paclitaxel). Agnostos trial is a part of a larger clinical and translational initiative to improve the outlook of patients with cancer of unknown primary through evaluation of novel chemotherapeutic regimens.
Detailed description
Treatment-naïve patients with CUP diagnosis confirmed according to CUP Diagnostic Guidelines, will be enrolled into AGNOSTOS trial. Patients will be randomized upfront to receive a nab-paclitaxel-based duplet adding either carboplatin or gemcitabine until progression or unacceptable toxicity (randomization 1:1, n= 120; 60 per arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: nab-paclitaxel, Drug: Gemcitabinenab-paclitaxel 125 mg/m2 on Days 1 and 8 by IV administration over 30 minutes without premedication, followed by gemcitabine 1000 mg/m2 on Days 1 and 8 by IV administration over 30 minutes. Treatment to be repeated Q21 days. |
| Arm B | Experimental | Drug: nab-paclitaxel, Drug: Carboplatinnab-paclitaxel 125 mg/m2 on Days 1 and 8 by IV administration over 30 minutes without premedication, followed by carboplatin AUC 2 on Day 1 and 8 by IV administration over 60 minutes. Treatment to be repeated Q21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provision of written informed consent.
- Patients must be ≥ 18 years of age.
- Diagnosis of CUP according to CUP Diagnostic Guidelines derived from ESMO 2011 and NCCN 2015 guidelines.
- Sufficient archived biopsy tissue from a surgical or core needle biopsy required to perform the CUP multiplex assay.
- Eastern Cooperative Oncology Group performance status ≤ 2.
Key exclusion criteria (13 listed)
- Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, breast Ductal Carcinoma in Situ (DCIS), stage 1 grade 1 endometrial carcinoma.
- Specific treatable CUP syndromes including: extragonadal germ cell syndrome; neuroendocrine carcinoma; adenocarcinoma isolated to axillary lymph nodes (women cancer); peritoneal carcinomatosis (women - ovarian cancer); squamous carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes; single resectable metastasis.
- Patients receiving any radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry.
- Patients with symptomatic uncontrolled brain metastases.
- Major surgery within 2 weeks of starting the study and patients must have recovered from any effects of any major surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nab-paclitaxelAlso: Abraxane | Drug | Arm A, Arm B |
| Carboplatin | Drug | Arm B |
| Gemcitabine | Drug | Arm A |
Primary outcome
Objective response rate (ORR) as evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.
Time frame: 42 months
4 secondary outcomes
duration of response according to RECIST version 1.1.
Time frame: 42 months
time to progression
Time frame: 42 months
overall survival
Time frame: 42 months
toxicity according to Common Terminology Criteria for Adverse Events - CTCAE version 4.03.
Time frame: 42 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nab-paclitaxel, Carboplatin and Gemcitabine in people with Unknown Primary Tumors, run by Fondazione del Piemonte per l'Oncologia at 10 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) as evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines. (time frame: 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.