A Phase-I dose escalation study to evaluate Safety of NRC-1111.
- Conditions
- Health Condition 1: C508- Malignant neoplasm of overlappingsites of breastHealth Condition 2: C348- Malignant neoplasm of overlappingsites of bronchus and lungHealth Condition 3: C108- Malignant neoplasm of overlappingsites of oropharynxHealth Condition 4: C569- Malignant neoplasm of unspecifiedovary
- Registration Number
- CTRI/2023/03/051121
- Lead Sponsor
- ATCO Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Patients will be considered eligible for the study based on the following criteria:
1. Patients willing and able to provide voluntary written informed consent and to follow the protocol requirements.
2. Male or female patients aged 18 years or older at the time of consent.
3. Patients must have life expectancy = 8 weeks.
4. ECOG Performance Score less than or equal to 2.
5. Patients with histologically documented, confirmed diagnosis of an advanced solid
malignancy for whom standard treatment options do not exist. Tumours must have
progressed (RECIST v1.1) on the last line of therapy before enrolment into the study.
6. Patients must have measurable lesion per RECIST v1.1.
8. Patients must not have received chemotherapy within 30 days and radiotherapy within
3 weeks and must not have undergone surgery within 2 weeks before dosing.
9. Patients must be willing to practice birth control during and for 6 months after
treatment.
10. Negative urine pregnancy test within 72 hours before starting study treatment in all premenopausal
women (PMS) and woman with < 12 months after onset of menopause.
This test is not required for women who have undergone hysterectomy and sterilization.
11. Women of childbearing potential, (defined as women physiologically capable of becoming pregnant) they must agree to use effective method of contraception during dosing and for at least 06 months after the treatment discontinuation) practicing
two acceptable methods of contraception.
12. Male patients must agree to use a condom.
• Patient is non-fertile (orchiectomy) or has a female partner
of nonchildbearing potential (i.e., postmenopausal,
surgically sterile).
• Patient and his female partner must agree to use an
adequate contraceptive method throughout the study
period and for 6 months following the last dose of
investigational product.
• Male patient engaged in sexual activity with a pregnant
female is required to use a condom throughout the study
period and for 6 months following the last dose of
investigational product.
Acceptable methods of contraception include the following:
• Intrauterine devices plus condoms
• Double-barrier methods (e.g., condoms and diaphragms with spermicidal gel or foam)
• Hormonal contraceptives (oral, depot, patch, injectable, or
vaginal ring), stabilized for at least 30 days prior to the
screening visit, plus condoms. Note: If the patient becomes
sexually active during the study, she should use one of the
other acceptable methods noted above in addition to the hormonal contraceptive until it has been stabilized for 30 days.
Patients meeting any of the following criteria will be excluded from the study:
1. Has a major illness, including active cardiac, hepatic, endocrine, pulmonary, autoimmune disease, interstitial lung disease, renal or psychiatric disorders, inadequately controlled with therapy corresponding to the illness.
2. Patients with brain metastases or primary CNS
malignancies. Radiological confirmation is required for symptomatic patients only.
3. Patients receiving concurrent therapy for the cancer (Radiation therapy, chemotherapy).
4. Has tested positive for HIV, HBsAg, HCV antibody, or HCV RNA at screening. However, patients who test positive for HCV antibody, but negative for HCV RNA, will be allowed. In addition, patients with controlled HIV, chronic HBV on suppressive antiviral therapy, or a history
of HCV infection status post-curative antiviral treatment
with an HCV viral load below limit of quantification are permitted to participate.
5. Has baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >480 milliseconds [CTCAE Grade 1] using Fredericia’s QT correction formula).
6. Patients who are pregnant or lactating.
7. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study, and which may obscure the evaluation of toxicity or alters drug
metabolism.
8. Impairment of gastrointestinal function that could significantly alter the absorption of the study drug and also the use of medication altering gastric pH (mild antacids are permitted if taken either 2 hours before or after the study drug administration).
9. Prior treatment with mTOR inhibitors in advanced malignancies.
10. Patients who received PI3K inhibitor(s) in any stage of their treatment.
11. Patients who tested positive for Coronavirus infection (COVID-19) at the time of enrolment.
12. Participation in any clinical study within 60 days before the first dose of Investigational Product.
13. Patients who are participating in any other clinical trial (both academic and industry run trials).
14. Patients with clinically manifest diabetes mellitus (treated and/or with clinical signs or with fasting glucose > 140 mg/dL or 7.8 mmol/L, HbA1c > 5.7), history of gestational diabetes mellitus or documented steroid induced diabetes mellitus.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method