Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT02052492
Eligibility Criteria:
Inclusion Criteria:
1. Patients diagnosed with inoperable, recurrent or metastatic tumor, deemed incurable, and who have either failed to respond to standard therapy or for whom no standard therapy is available or refuse to receive standard therapies or in case of SCC, the investigator decides that delay of the standard therapy does not have any risk for the patient.
2. Histologically or cytological-confirmed diagnosis of solid tumor on file. For the expanded cohort only the following immunological tumors will be recruited: epithelial ovarian cancer, cervical carcinoma, head \& neck cancer, melanoma, kidney cancer (RCC), gastric cancer, lung cancer (SCLC or NSCLC), sarcoma, bladder cancer or squamous cell carcinoma (SCC) of the skin.
3. Measurable disease (i.e., present with at least one measurable lesion per modified RECIST, version 1.1).
4. Age: 18-80 years.
5. BMI: 18-36.
6. ECOG Performance Status 0 or 1.
7. Estimated life expectancy of at least 4 months.
8. Off prior chemotherapy, radiation therapy with curative intent, hormonal therapy, immunotherapy, biological therapies (excluded checkpoint inhibitors and Erbitux), immunosuppressive therapy \[e.g., cyclosporine, humera, prograf, etc.\] or immunomodulators \[e.g., thalidomide, revlimid, etc.\] for at least 4 weeks. Hormonal treatment is not allowed ONLY if given as an anti-cancer therapy. In any case the sponsor should be consulted prior to final decision.
Prior treatment with checkpoint inhibitors (such as anti PD-1, anti PDL-1), and/or Erbitux, and/or palliative irradiation, does not require any wash out period before commencement of study drug treatment.
Patients who were receiving mitomycin C, nitrosoureas, or carboplatin must be 6 weeks from the last administration of chemotherapy.
9. Patients must have adequate organ and marrow function within 7 days of first dosing. Hematology re-test results must keep meeting eligibility criteria on Day 1 of treatment prior to dosing.
10. All prior anti-cancer treatment-related toxicities (except alopecia and certain laboratory values) must be ≤ Grade 1 according to the Common Terminology Criteria for Adverse Events at the time of start of treatment. Stable grade 2 peripheral neuropathy secondary to neurotoxicity and/or chronic stable grade 2 radiotherapy related toxicity from prior therapies may be considered on a case by case basis.
11. No extensive radiotherapy (e.g., whole-pelvis, greater than 50% of neuroaxis, whole abdomen, whole body) within 12 months prior to start of study treatment.
12. No bone marrow transplantation within 3 years prior to start of study treatment.
13. Women and man of child bearing potential practicing an acceptable method of birth control during the study and at least 3 months after completion.
14. Female patient of childbearing potential has a negative serum pregnancy test within 7 days of first dose.
15. Understanding study procedures and willingness to comply for the entire length of the study and to provide written informed consent.
16. Patient has previously received maximum 3 regimens of systemic antineoplastic therapies.
Exclusion Criteria:
1. Current evidence of active and uncontrolled infection.
2. Known Cirrhosis.
3. Treatment refractory hypertension (blood pressure of systolic\> 150 mmHg and/or diastolic \> 95 mm Hg) which cannot be controlled by anti-hypertensive therapy;
4. A history or evidence of current Class IV congestive heart failure.
5. Current left ventricular ejection fraction \< 50%
6. A history of acute coronary syndromes, coronary angioplasty.
7. Use of nonsteroidal anti-inflammatory drugs - including Aspirin - and/or any steroids within 7 days prior to start of study treatment (excluding eye drops and ointments). Those medications must be stopped or replaced by another equivalent permitted medication at least 7 days prior to Day 1. Those medications will be allowed within 7 days prior to start of treatment only if required as premedication prior to CT scan for patients who are allergic to the contrast media.
8. Patient has a known hypersensitivity to the components of study drug, its analogs, or drugs of similar chemical or biologic composition.
9. Patients with known brain metastases.
10. Patient has known psychiatric or substance abuse disorders that is uncontrolled and would interfere with cooperation with the requirements of the trial.
11. Patient is Human Immunodeficiency virus (HIV)-positive.
12. Evidence of active bleeding or bleeding diathesis, including blood or platelet transfusion within 14 days of the commencement of study treatment.
13. Patients with known chronic active hepatitis, hepatitis B virus (HBV) or hepatitis C virus (HCV) carriers.
14. Any known autoimmune disorders other than hypothyroidism or B12 deficiency.
15. Female subjects who are pregnant or nursing.
16. Use of alternative medicine (products only) and Herbal drugs with cancer treatment intent is not allowed within 7 days prior to start of study treatment and during the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02052492
Study Brief:
Protocol Section:
NCT02052492