Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Fallopian Tube Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Conatumumab

Antineoplastic Agents, Immunological

Dose Escalation:

Dose Level (1) - 13 mg/m2 (twice a week for 3 of 4 weeks); Dose Level (-1) - 11 mg/m2 (twice a week for 3 of 4 weeks); Dose Level (2) - 13 mg/m2 (twice weekly for 4 weeks );

Birinapant

10 mg/kg IV on Day 1 and 15 of each cycle

This is a dose escalation study in female subjects with relapsed ovarian cancer (including epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer). Approximately 30 to 40 subjects will be administered a combination of conatumumab and birinapant.

In the initial dose-escalation stage of the study, adult female subjects will receive conatumumab in combination with increasing doses of birinapant in dose-escalation cohorts to determine the MTD of birinapant when administered with a fixed dose of conatumumab.

In safety expansion stage, adult female subjects will receive conatumumab in combination with birinapant at the MTD of the combination.

Study of Birinapant in Combination With Conatumumab in Subjects With Relapsed Ovarian Cancer

A Phase 1b, Open-label, Non-randomized Multicenter Study of Birinapant in Combination With Conatumumab in Subjects With Relapsed Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

TetraLogic Pharmaceuticals

Symptoms and General Pathology

Recurrence

Disease Attributes

Carboplatin

Nuc-1031 IV injection on day 1 and day 8 repeated every 21 days Carboplatin IV infusion on day 1 repeated every 21 days.

Dose escalation will be done using 3+3 dose escalation design

Nuc-1031 IV injection on day 1 and day 8 repeated every 21 days Carboplatin IV infusion on day 1 repeated every 21 days (Total 6 cycles)

Nuc-1031 and Carboplatin

Sarah Blagden, MBBS, MRCP

A first in human experimental treatment in which an experimental medicine,Nuc-1031, is used in combination with a standard cancer medicine, carboplatin, to treat ovarian cancer which reappear after standard cancer treatment. The aim of the trial is to determine safety, effectiveness, and clinical activity of this combination treatment.

Nuc-1031 and carboplatin combination is a new experimental treatment for ovarian cancer which reappear after standard chemotherapy. Chemotherapy is the name for drug treatments to kill or control the growth of cancer cells. Although there is some evidence from laboratory and clinical studies that Nuc-1031 is effective in the treatment of ovarian cancer, it has not yet been tested in combination with another chemotherapy drug. So this combination treatment is classed as a first in human study(Phase1B). The aim of the study is to investigate whether adding Nuc-1031 to carboplatin can improve the benefits of chemotherapy.

Other purposes are to find out whether Nuc-1031 is safe to give with carboplatin, to identify the correct dose of Nuc-1031 when given with carboplatin and establish how effective the combination is at treating ovarian cancer. This study is also designed to enable us to find out whether Nuc-1031 adds further benefit, over and above that achieved by carboplatin alone, when treating ovarian cancer. and carboplatin combination will be given in six cycles. Each cycle is 3 weeks long. On first day of first week of each cycle (day1), selected study participants will receive one dose of both Nuc-1031 and Carboplatin chemotherapy. Following this, the study participant will receive a second dose of Nuc-1031 alone on first day of second week (day 8). This schedule will be repeated every 3 weeks for 6 cycles.

Safety and Efficacy Study of Nuc-1031 and Carboplatin Combination to Treat Recurrent Ovarian Cancer

Phase 1B Open Label Study to Assess the Safety, Pharmacokinetics and Clinical Activity of Nuc-1031 Given on Days 1 & 8 With Carboplatin on Day 1, q3-weekly for 6 Cycles in Participants With Recurrent Ovarian Cancer.

Imperial College Healthcare NHS Trust

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Birinapant in Combination With Conatumumab in Subjects With Relapsed Ovarian Cancer	NCT01940172	Relapsed Epithe... Relapsed Primar... Relapsed Fallop...	Birinapant Conatumumab	18 Years -	TetraLogic Pharmaceuticals
Safety and Efficacy Study of Nuc-1031 and Carboplatin Combination to Treat Recurrent Ovarian Cancer	NCT02303912	Recurrent Ovari...	Nuc-1031 and Ca...	18 Years -	Imperial College Healthcare NHS Trust
Study of Birinapant in Combination With Conatumumab in Subjects With Relapsed Ovarian Cancer	NCT01940172	Relapsed Epithe... Relapsed Primar... Relapsed Fallop...	Birinapant Conatumumab	18 Years -	TetraLogic Pharmaceuticals

Spots Global Cancer Trial Database for relapsed fallopian tube cancer