Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Neoplasms, Unknown Primary

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasm Metastasis

Neoplastic Processes

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Belinostat

Tubulin Modulators

Antimitotic Agents

Histone Deacetylase Inhibitors

Enzyme Inhibitors

Group A: belinostat 1000 mg/m² administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat 2000 mg administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel 175 mg/m² administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.

Group B: paclitaxel 175 mg/m² administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.

belinostat, carboplatin, paclitaxel

carboplatin, paclitaxel

e-mail contact via enquires@topotarget.com

The purpose of this study is to assess efficacy and safety of belinostat in combination with carboplatin and paclitaxel in patients with previously untreated carcinoma of unknown primary.

This is an open-label, multinational, multicenter, randomized, comparative efficacy and safety study in previously untreated patients with carcinoma of unknown primary. Patients meeting inclusion and exclusion criteria will be randomized to treatment in Arm A (BelCaP) or Arm B (CaP).

Belinostat, Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Cancer of Unknown Primary

An Open-label Randomized Phase II Trial of Belinostat (PXD101) in Combination With Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Previously Untreated Carcinoma of Unknown Primary

Time from the date of randomization to the time of disease progression or death due to any cause, measured by RECIST criteria (Response Evaluation Criteria In Solid Tumors).

The best overall response in an individual patient according to the RECIST criteria (Eisenhauer 2009 ) is the best response recorded from the start of the treatment until disease progression/recurrence. Objective response is defined as best overall response of complete response (CR) or partial response (PR)

Time from the date of randomization to the date of death

For patients with overall best response being CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status is recorded first) were met

Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date that PD (\[Progressive Disease\]) or death was documented

Time from the date of randomization to the time of disease progression

Spectrum Pharmaceuticals, Inc

Valerio Therapeutics

Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication

Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.

Arm A - BelCaP

Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.

Arm B - CaP

Total

Age, Categorical

Sex: Female, Male

PRS Administrator Gunilla Emanuelson

Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population, 12 patients (5 in Arm A and 7 in Arm B) were censored due to lack of efficacy

Progression Free Survival

Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population.

Best Overall Response

Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. 18 patients (10 in Arm A and 8 in Arm B) were censored.

Overall Survival (OS)

Patients with overall best response being either complete response or partial response.

Time to Response

Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. Three patients, 2 in Arm A and 1 in Arm B, were not treated with study medication

Duration of Response

Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. 26 patients (12 in Arm A and 14 in Arm B) were censored. One patient in each arm had no information reported.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Belinostat, Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Cancer of Unknown Primary	NCT00873119	Carcinoma of Un...	belinostat, car... carboplatin, pa...	18 Years -	Valerio Therapeutics
Belinostat, Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Cancer of Unknown Primary	NCT00873119	Carcinoma of Un...	belinostat, car... carboplatin, pa...	18 Years -	Valerio Therapeutics

Spots Global Cancer Trial Database for belinostat, carboplatin, paclitaxel