Study Of Nintedanib Compared To Chemotherapy in Patients With Recurrent Clear Cell Carcinoma Of The Ovary Or Endometrium

Summary

The trial will recruit up to 120 patients; 90 with ovarian clear cell carcinoma and up to 30 with endometrial clear cell carcinoma. Patients will be randomised between chemotherapy and Nintedanib 200mg twice daily oral administration (PO) continuously. The primary diagnosis must be histologically confirmed and central pathological review of the presenting tumour or biopsy of relapsed disease must find at least 50% clear cell carcinoma with no serous differentiation

Conditions

• Ovarian Clear Cell Carcinoma
• Endometrial Clear Cell Carcinoma

Interventions

DRUG

Nintedanib

Nintedanib (BIBF1120) 200mg twice daily PO, continuously, until progression or withdrawal from the treatment.

DRUG

Paclitaxel

Ovarian Cancer Patients Paclitaxel (80mg/m2) IV Day 1, 8, 15 every 28 days\* Endometrial Cancer Patients Carboplatin (AUC 5) and Paclitaxel (175mg/m2) IV every 21 days\* \* Patients will usually receive up to 6 cycles of chemotherapy. If in the opinion of the Investigator, a patient would benefit from continuing with chemotherapy beyond 6 cycles, it is acceptable to continue until progression or unacceptable toxicity.

DRUG

Pegylated Liposomal Doxorubicin (PLD)

Ovarian Cancer Patients Pegylated Liposomal Doxorubicin (PLD) (40mg/m2) IV every 28 days\* \* Patients will usually receive up to 6 cycles of chemotherapy. If in the opinion of the Investigator, a patient would benefit from continuing with chemotherapy beyond 6 cycles, it is acceptable to continue until progression or unacceptable toxicity. The maximal lifetime cumulative dose of doxorubicin or pegylated liposomal doxorubicin allowed is 450 mg/m2.

DRUG

Topotecan

Ovarian Cancer Patients Topotecan 4mg/m2 IV Day 1, 8, 15 every 28 days\* \* Patients will usually receive up to 6 cycles of chemotherapy. If in the opinion of the Investigator, a patient would benefit from continuing with chemotherapy beyond 6 cycles, it is acceptable to continue until progression or unacceptable toxicity.

DRUG

Carboplatin

Endometrial Cancer Patients Carboplatin (AUC 5) and Paclitaxel (175mg/m2) IV every 21 days\* \* Patients will usually receive up to 6 cycles of chemotherapy. If in the opinion of the Investigator, a patient would benefit from continuing with chemotherapy beyond 6 cycles, it is acceptable to continue until progression or unacceptable toxicity.

DRUG

Doxorubicin

Endometrial Cancer Patients Doxorubicin IV 60mg/m2 every 21 days\* \* Patients will usually receive up to 6 cycles of chemotherapy. If in the opinion of the Investigator, a patient would benefit from continuing with chemotherapy beyond 6 cycles, it is acceptable to continue until progression or unacceptable toxicity. The maximal lifetime cumulative dose of doxorubicin or pegylated liposomal doxorubicin allowed is 450 mg/m2.

Sponsors & Collaborators

• Boehringer Ingelheim

  collaborator INDUSTRY

• Cancer Research UK

  collaborator OTHER

• European Organisation for Research and Treatment of Cancer - EORTC

  collaborator NETWORK

• Nordic Society of Gynaecological Oncology - Clinical Trials Unit

  collaborator OTHER

• ARCAGY/ GINECO GROUP

  collaborator OTHER

• NHS Greater Glasgow and Clyde

  lead OTHER

Principal Investigators

• Rosalind Glasspool · NHS Greater Glasgow and Clyde

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-30

Primary Completion

2020-03-31

Completion

2021-03-31

Countries

• United Kingdom

Study Locations