NCT01266447|CompletedPhase 2ResultsDMC

Veliparib, Topotecan Hydrochloride, and Filgrastim or Pegfilgrastim in Treating Patients With Persistent or Recurrent Cervical Cancer

A Phase II Evaluation of ABT-888 (NCI Supplied Agent: ABT-888, NSC #737664), Topotecan (NSC # 609699) and Filgrastim or Pegfilgrastim in the Treatment of Persistent or Recurrent Squamous or Non-squamous Cell Carcinoma of the Cervix

National Cancer Institute (NCI)ClinicalTrials.gov

Compare

5 other identifiers

NCI-2011-02659GOG-0127WCDR0000691281U10CA180868U10CA027469

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredDec 2010

StartedFeb 2011

CompletionJan 2016

Brief Summary

This phase II clinical trial is studying the how well veliparib, topotecan hydrochloride, and filgrastim or pegfilgrastim work in treating patients with persistent or recurrent cervical cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by blocking them from dividing. Giving veliparib with chemotherapy may kill more tumor cells. Filgrastim or pegfilgrastim may cause the body to make more blood cells and help it recover from the side effects of chemotherapy.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Feb 2011

Longer than P75 for phase_2

Geographic Reach

1 country

78 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.9 years study duration

First Submitted

Initial submission to the registry

December 23, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 24, 2010

Completed

1 month until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed

4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

February 1, 2017

Completed

Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

4.9 years

First QC Date

December 23, 2010

Results QC Date

December 7, 2016

Last Update Submit

August 6, 2019

Conditions

Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Small Cell Carcinoma Cervical Squamous Cell Carcinoma Recurrent Cervical Carcinoma Stage III Cervical Cancer Stage IVA Cervical Cancer Stage IVB Cervical Cancer

Outcome Measures

Primary Outcomes (3)

Tumor Response
Complete and Partial Tumor Response as Assessed by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), at least 30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.
Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicted based on symptoms or physical signs suggestive of progressive disease. The average time was 2.3 months
Number of Patients With Dose-limiting Toxicities (in Safety lead-in)
A dose-limiting toxicity (DLT) is assessed by NCI CTCAE v4, occurring during cycle 1 of therapy.: A dose-limiting toxicity (DLT) is defined as either hematologic or non-hematologic toxicity assessed by NCI CTCAE v4, occurring during cycle 1 of therapy, which cause any of the following: For hematologic toxicity - dose delay of greater than 2 weeks due to failure to recover counts, Treatment related febrile neutropenia, grade 4 neutropenia lasting \>7 days, treatment related grade 4 thrombocytopenia or clinically significant bleeding with grade 3 thrombocytopenia. For non-hematologic toxicity; study treatment related grade 3 or 4 non-hematological toxicity (excluding anorexia, constipation, fatigue, hypersensitivity/allergic reaction to one of the study drugs, nausea \& vomiting, and grade 3 dehydration), grade 4 nausea and vomiting for \>48 hours despite maximum medical management, electrolyte imbalance of \> or equal to grade 3 that can be replaced within 48 hours; any drug related death
Up to 21 days
Adverse Events (Grade 3 or Higher) During Treatment Period
Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.
During treatment period and up to 30 days after stopping the study treatment.The average of study treatment time was 2.3 months.

Secondary Outcomes (3)

Progression-free Survival
From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.
Overall Survival
From study entry to death or last contact, up to 5 years of follow-up.
Duration of Objective Response
Every other cycle for first 6 months; then every 3 months until disease progression confirmed; and at any other time if clinically indicated based on symptoms or signs suggestive of progressive disease.The average of study treatment time was 2.3 months.

Study Arms (1)

Treatment (veliparib, topotecan hydrochloride, filgrastim)

EXPERIMENTAL

Patients receive veliparib PO twice daily and topotecan hydrochloride IV over 30 minutes once daily on days 1-5. Patients also receive, according to institutional standard, filgrastim SC beginning on day 6, 7, or 8 and continuing until hematopoietic recovery or pegfilgrastim SC on day 6, 7, or 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Biological: FilgrastimOther: Laboratory Biomarker AnalysisBiological: PegfilgrastimDrug: Topotecan HydrochlorideDrug: Veliparib

Interventions

FilgrastimBIOLOGICAL

Given SC

Also known as: Filgrastim XM02, G-CSF, Neupogen, r-metHuG-CSF, Recombinant Methionyl Human Granulocyte Colony Stimulating Factor, rG-CSF, Tbo-filgrastim, Tevagrastim