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Ovarian CancerPhase 1/2NCT01690598

Veliparib and Topotecan for Relapsed Ovarian Cancer With Negative or Unknown BRCA Status

A Phase 1/2 study testing Veliparib and Topotecan in people with Ovarian Cancer, run by Vejle Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate the effect of combined topotecan and veliparib (ABT888) treatment in relapsed ovarian cancer with tumor progression and negative or unknown BRCA mutation status. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Veliparib and Topotecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteDenmark
Study dates
Nov 2012to Feb 2015
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.
  • Verified progression by either RECIST criteria and/or GCIG CA125 criteria after previous first line chemotherapy or progression after later lines of cytotoxic treatment.
  • Platinum resistance or partially platinum sensitive disease
  • Relapsed within six months of prior first line/later lines of platinum-based therapy or
  • Relapsed within six-twelve months of prior first line/later lines of platinum-based therapy
  • Age ≥ 18 years.
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  • Performance status 0-2.
  • Measurable disease by RECIST 1.1 or CA125 GCIG criteria
  • Adequate bone marrow function, liver function, renal function and coagulation parameters (within 7 days prior to enrollment):
  • WBC ≥ 3.0 x 10^9/l or neutrophils (ANC) ≥ 1.5 x 10^9/l
  • Platelet count ≥ 100 x 109/l
  • Hemoglobin ≥ 9.7 g/dl (6 mmol/L)
  • Serum bilirubin ≤ 1.5 x ULN
  • Serum transaminases ≤ 2.5 x ULN
  • Serum creatinine ≤ 1.5 x ULN
  • Written informed consent.
  • Tissue available for BRCAness analysis/BRCA mutation analysis.

Who cannot join

  • Prior treatment with a PARP inhibitor.
  • Patients with BRCA1/2 germline mutation.
  • Platinum-refractory disease (disease that progressed or was stable during prior platinum therapy)
  • Patients who have received (or are planning to receive) treatment with any other investigational agent, or who have participated in another clinical trial within 28 days prior to entering this trial.
  • Pregnant or breast-feeding. For fertile women a negative pregnancy test at screening is mandatory.
  • Fertile patients not willing to use acceptable and safe methods of contraception during and for 6 months after treatment
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  • Other present or previous malignancy except curatively treated cervical cancer stage I, non-melanotic skin cancer or other cancer with minimal risk of relapse. Previous breast cancer is allowed, if disease free follow-up at least five years prior to enrollment.
  • CNS metastasis.
  • History of any chronic medical or psychiatric condition or laboratory abnormality, which is not medically controlled or in the opinion of the Investigator may increase the risks associated with study drug administration (e.g. diabetes, cardiac diseases, hypertension, renal or liver disease).
  • Allergy to the ingredients of the study medication.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Oncology, Vejle Hospital

    Vejle, DK-7100

Other trials in Denmark

About this study

Official title: Veliparib (ABT888) and Topotecan (Hycamtin®) for Patients With Platinum-Resistant or Partially Platinum-Sensitive Relapse of Epithelial Ovarian Cancer With Negative or Unknown BRCA Status

The purpose of this study is to investigate the effect of combined topotecan and veliparib (ABT888) treatment in relapsed ovarian cancer with tumor progression and negative or unknown BRCA mutation status.

Conditions
Ovarian Cancer
Being tested
Veliparib, Topotecan
Keywords
Epithelial ovarian cancer, BRCA mutation, Platinum resistant, Platinum sensitive, Relapsed ovarian cancer
Medical subject headings
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VeliparibDrug

    Veliparib (tablet) twice daily on days 1-3, 7-9, and 14-16 in a 28 days cycle. In phase I the starting dose is 30 mg x 2.

  • TopotecanDrug

    2 mg/m² iv over 30 minutes on days 2, 8, and 15 in cycles of 28 days. Topotecan is dosed at a maximum body surface area of 2 m².

Study groups in NCT01690598
Study groupRoleWhat they receive
Veliparib and TopotecanExperimentalNot described
Receives: Drug: Veliparib; Drug: Topotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I: Maximum tolerated dose, dose limiting toxicity and thus recommend phase II dose of veliparib

    Measured: 1 month

  2. Phase II: To investigate response rates (based on either CA125 GCIG or RECIST criteria) of combination topotecan and veliparib (ABT888) in relapsed ovarian cancer with negative or unknown BRCA status

    Measured: Every three months, up to 3 years

Secondary outcomes (2)

  1. Progression free survival of ovarian cancer patients treated with topotecan and veliparib

    Measured: Every three months up to three years

  2. Overall survival of ovarian cancer patients treated with topotecan and veliparib

    Measured: Every three months, up to three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionJan 2015
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01690598
Sponsor's protocol ID
VeTo
Status last verified
Jun 2015
First submitted
17 Sep 2012
Last updated
10 Jun 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Hjortkjaer M, Kanstrup H, Jakobsen A, Steffensen KD. Veliparib and topotecan for patients with platinum-resistant or partially platinum-sensitive relapse of epithelial ovarian cancer with BRCA negative or unknown BRCA status. Cancer Treat Res Commun. 2018;14:7-12. doi: 10.1016/j.ctarc.2017.09.001. Epub 2017 Sep 27. No abstract available.

    PubMed 30104007

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Veliparib and Topotecan in people with Ovarian Cancer, run by Vejle Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: Maximum tolerated dose, dose limiting toxicity and thus recommend phase II dose of veliparib (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01690598, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2015.

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