Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Itraconazole

Hydroxyitraconazole

Clotrimazole

Miconazole

Antifungal Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Hormones

Hormone Antagonists

Cytochrome P-450 CYP3A Inhibitors

Group I (Placebo group; n=33) which will be treated with chemotherapy which includes paclitaxel 60 mg/m2 IV over 1 hour followed by carboplatin area under the curve 2 (AUC 2) IV over 30 minutes Day 1, 8, and 15 which will be repeated every 21 days for 6 cycles 12 plus 4 placebo capsules for 5 days (two days before chemotherapy, the day of chemotherapy after receiving it, and two days after chemotherapy).

Group II: (Itraconazole group; n=33) which will be treated with chemotherapy which includes paclitaxel 60 mg/m2 IV over 1 hour followed by carboplatin AUC 2 IV over 30 minutes Day 1, 8, and 15 repeated every 21 days for 6 cycles 12 plus oral itraconazole 400 mg (4 capsules, each of 100 mg) for 5 days (two days before chemotherapy, the day of chemotherapy after receiving it, and two days after chemotherapy).

Oral itraconazole 400 mg (4 capsules, each of 100 mg) for 5 days (two days before chemotherapy, the day of chemotherapy after receiving it, and two days after chemotherapy) Day 1, 8, and 15 repeated every 21 days for 6 cycles for group II

Itraconazole capsule

4 placebo capsules for 5 days (two days before chemotherapy, the day of chemotherapy after receiving it, and two days after chemotherapy) Day 1, 8, and 15 repeated every 21 days for 6 cycles for group I

Placebo

Ahmed ES Besheir, Master

Tarek M Mostafa, Professor

This is a randomized, placebo controlled; parallel study that will be conducted on 66 female patients with advanced epithelial ovarian carcinoma (stage III and stage IV) to compare effect of adding Itraconazole to paclitaxel and carboplatin versus placebo to paclitaxel and carboplatin as regard overall response rate (ORR) and Disease control rate (DCR) and Quality of life (QOL) and the change in the serum concentrations of the biological markers.

This is a randomized, placebo controlled; parallel study that will be conducted on 66 female patients with advanced epithelial ovarian carcinoma (stage III and stage IV). The staging of the disease will be done according to 8th edition of American Joint Committee on Cancer (AJCC), TNM staging. The patients will be recruited from Oncology Department, Tanta University Hospital. The patients will receive a combination of paclitaxel and carboplatin chemotherapy with or without itraconazole. Randomization will be carried out based on hospital admission days where the patients will be randomized into the following two groups to compare effect of adding Itraconazole to paclitaxel and carboplatin versus placebo to paclitaxel and carboplatin.

Measuring tumor response in epithelial ovarian carcinoma

Itraconazole in Advanced Ovarian Cancer

The Possible Effect of Itraconazole as add-on Therapy to Paclitaxel and Carboplatin on the Treatment Outcome in Patients With Advanced Ovarian Cancer

The change between 2 groups in overall response rate and disease control rate using the Response Evaluation Criteria in Solid Tumors (RECIST), version. 1.1.

* Serum cancer antigen-125 (CA-125) level which will be assessed at baseline for all patients, after the third chemotherapy cycle and after the sixth chemotherapy cycle if it is positive at initial presentation.
* Serum vascular endothelial growth factor receptor-2 (VEGFR-2) level by ELISA which will be assessed at baseline and after the sixth chemotherapy cycle.
* Serum P-glycoprotein level by ELISA which will be assessed at baseline and after the sixth chemotherapy cycle.

Tanta University

Clinical Pharmacist

Rifampin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Itraconazole capsules, 0.2g once daily from Day 3 to Day 10 TQB3909 tablets, single oral dose on Day 1 and Day 8.

Rifampicin capsule, 0.6g once daily from Day 3 to Day 11. TQB3909 tablets, single oral dose on Day 1 and Day 10.

TQB3909 tablets

Itraconazole capsule is a strong inhibitor of CYP3A4.

Rifampicin capsule is a strong inducer of CYP3A4.

Rifampicin capsule

Fei Hua, MD, PhD

Weiying Gu, MD, PhD

This is a single-center, open, single-dose, self-controlled phase I clinical trial to evaluate the effects of Itraconazole Capsules/Rifampicin Capsules on pharmacokinetics of TQB3909 tablets in vivo, and the safety of TQB3909 tablets and combined with Itraconazole Capsules/Rifampicin Capsules after single oral dose.

A Study to Evaluate Drug-Drug Interaction of TQB3909 Tablets

A Phase I Study to Evaluate Drug-Drug Interaction of TQB3909 Tablets

Time to reach maximum (peak) plasma concentration following drug administration.

The maximum observed plasma concentration of TQB3909

The time required for half of the drug to be eliminated from the plasma.

Incidence of adverse events (AEs) based on the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Itraconazole in Advanced Ovarian Cancer	NCT05591560	Ovarian Carcino...	Itraconazole ca... Placebo	18 Years - 65 Years	Tanta University
A Study to Evaluate Drug-Drug Interaction of TQB3909 Tablets	NCT06165822	Advanced Malign...	TQB3909 tablets Itraconazole ca... Rifampicin caps...	18 Years - 45 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Study to Evaluate Drug-Drug Interaction of TQB3909 Tablets	NCT06165822	Advanced Malign...	TQB3909 tablets Itraconazole ca... Rifampicin caps...	18 Years - 45 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Study to Evaluate Drug-Drug Interaction of TQB3909 Tablets	NCT06165822	Advanced Malign...	TQB3909 tablets Itraconazole ca... Rifampicin caps...	18 Years - 45 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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