A clinical trial exploring number of cycles for weekly treatment with Paclical® in patients with metastatic breast cancer, previously treated in study OAS-11PAC-W

A follow-up study exploring number of cycles for weekly treatment with Paclical® in patients with metastatic breast cancer, previously treated in study OAS-11PAC-W

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002456-14-LV

Enrollment

Registered

2011-08-19

Start date

2011-10-21

Completion date

Unknown

Last updated

2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Histologically confirmed metastatic breast cancer MedDRA version: 14.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: Paclical® Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: PACLITAXEL CAS Number: 33069-62-4 Concentration unit: mg milligram(s) Concentration type: equal Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Signed informed consent 2. Completion of study OAS-11PAC-W 3. Willingness and ability to comply with the protocol for the duration of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 7 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3

Exclusion criteria

Exclusion criteria: 1. Progressive disease at last visit of study OAS-11PAC-W 2. Dose-reduction during study OAS-11PAC-W 3. Unacceptable toxicity at last visit of study OAS-11PAC-W

Design outcomes

Primary

Measure	Time frame
Main Objective: To explore the number of cycles for weekly treatment with Paclical®;Secondary Objective: To further assess the efficacy and safety of weekly treatment with Paclical®;Primary end point(s): The primary efficacy endpoint is time in study measured as number of treatment cycles in relation to reason for completion (complete response, unacceptable toxicity or progressive disease).;Timepoint(s) of evaluation of this end point: Primary efficacy endpoint will be evaluated after the end of the study.	—

Measure

Time frame

Main Objective: To explore the number of cycles for weekly treatment with Paclical®;Secondary Objective: To further assess the efficacy and safety of weekly treatment with Paclical®;Primary end point(s): The primary efficacy endpoint is time in study measured as number of treatment cycles in relation to reason for completion (complete response, unacceptable toxicity or progressive disease).;Timepoint(s) of evaluation of this end point: Primary efficacy endpoint will be evaluated after the end of the study.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Proportion of complete responders (CR) 2. Proportion of patients with unacceptable toxicity 3. Kind of toxicity 4. Proportion of patients with progressive disease (PD) 5. Number, frequency and severity of adverse events, including standard haematology and clinical biochemistry lab tests, urinalysis and vital signs ;Timepoint(s) of evaluation of this end point: 1. Will be evaluated after the end of the study 2. Will be evaluated after the end of the study 3. Will be evaluated after the end of the study 4. Will be evaluated after the end of the study 5. Will be evaluated during the study	—

Measure

Time frame

Secondary end point(s): 1. Proportion of complete responders (CR) 2. Proportion of patients with unacceptable toxicity 3. Kind of toxicity 4. Proportion of patients with progressive disease (PD) 5. Number, frequency and severity of adverse events, including standard haematology and clinical biochemistry lab tests, urinalysis and vital signs ;Timepoint(s) of evaluation of this end point: 1. Will be evaluated after the end of the study 2. Will be evaluated after the end of the study 3. Will be evaluated after the end of the study 4. Will be evaluated after the end of the study 5. Will be evaluated during the study

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Countries

Latvia, Russian Federation

Contacts

Public ContactGatis Klaucans

OCT Baltic Ltd.

gklaucans@oct-clinicaltrials.com+37167 69 54 86

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026