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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02607202
Other study ID # 008-IRCC-10IIS-14
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 2015
Est. completion date January 31, 2022

Study information

Verified date January 2024
Source Fondazione del Piemonte per l'Oncologia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date January 31, 2022
Est. primary completion date May 4, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. - 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. Exclusion Criteria: - 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. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
nab-paclitaxel

Carboplatin

Gemcitabine


Locations

Country Name City State
Italy AOU Policlinoco S Orsola - Malpighi Bologna
Italy Investigative Clinical Oncology (Oncologia Medica 2) Candiolo Turin
Italy Ospedali Galliera Genova
Italy Istituto Europeo di Oncologia - IEO Milano
Italy Istituto Nazionale dei Tumori Milano
Italy Ospedale Niguarda Cà Granda Milano
Italy Istituto Oncologico Veneto - IOV Padova
Italy Fondazione IRCCS Policlinico San Matteo Pavia
Italy Policlinico Universitario Campus Biomedico Roma
Italy A.O.U S.Giovanni Battista Torino

Sponsors (1)

Lead Sponsor Collaborator
Fondazione del Piemonte per l'Oncologia

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective response rate (ORR) as evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines. 42 months
Secondary duration of response according to RECIST version 1.1. 42 months
Secondary time to progression 42 months
Secondary overall survival 42 months
Secondary toxicity according to Common Terminology Criteria for Adverse Events - CTCAE version 4.03. 42 months
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