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Ovarian CancerPhase 1NCT02483104

Veliparib in Combination With Carboplatin And Weekly Paclitaxel in Japanese Subjects With Ovarian Cancer

A Phase 1 study testing veliparib, carboplatin and paclitaxel in people with Ovarian Cancer, run by AbbVie at 3 sites in Japan.

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

This is a Phase 1, open-label, multicenter, dose escalation study evaluating the tolerability, safety, pharmacokinetics and preliminary efficacy of veliparib in combination with carboplatin and weekly paclitaxel in Japanese subjects with ovarian cancer. Read more about this study

Who is it for?
Ages 20 to 99 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
veliparib, carboplatin and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
3 sitesJapan
Study dates
Jul 2015to Jul 2016
Phase
Phase 1
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 20 to 99 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed epithelial ovarian, fallopian tube or primary peritoneal carcinoma the International Federation of Gynecology and Obstetrics (FIGO) Stage IC - IV with either optimal (< 1 cm residual disease) or suboptimal residual disease.
  • Participants must be newly diagnosed, chemotherapy-naïve, and entered between 1 and 12 weeks after initial cytoreductive surgery.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
  • Adequate organ and marrow function.
  • Ability to swallow and retain oral medication, and no uncontrolled emesis.
  • Women of childbearing potential (except vasectomized partner of female subjects) must agree to use adequate contraception prior to study entry, for the duration of study participation and up to 3 months following completion of therapy. Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the study entry. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.

Who cannot join

  • A history of another invasive cancer within the past 3 years, except non-melanoma skin cancer or in situ malignancies that are considered cured by the investigator (e.g., cervical cancer in situ, in situ carcinoma of the bladder, or breast carcinoma in situ).
  • Participants who received prior radiotherapy to any portion of the abdominal cavity or pelvis.
  • Participants who received prior chemotherapy for any abdominal or pelvic tumor.
  • Any investigational agents less than 4 weeks prior to study enrollment.
  • Any anti-cancer Chinese medicine/herbal remedies within 14 days prior to study enrollment.
  • Known history of allergic reaction to Cremophor-paclitaxel, carboplatin, Azo Colourant Tartrazine (also known as FD\&C Yellow 5 or E102), Azo Colourant Orange Yellow-S (also known as FD\&C Yellow 6 or E110) or known contraindications to any study supplied drug.
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  • Patients with history or evidence upon physical examination of central nervous system disease, including primary brain tumor, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) within 6 months of the first date of treatment on this study.
  • Prior therapy with a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.
  • Subject has a clinically significant uncontrolled condition(s), including but not limited to:
  • Uncontrolled seizure disorder, or focal or generalized seizure within the last 12 months;
  • Active infection that requires parenteral antibiotics;
  • Known active hepatitis B or hepatitis C with abnormal liver function test or organ dysfunction;
  • Symptomatic congestive heart failure; unstable angina pectoris; serious ventricular cardiac arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or serious cardiac arrhythmia requiring medication (this does not include asymptomatic atrial fibrillation with controlled ventricular rate); or myocardial infarction within the last 6 months;
  • Uncontrolled hypertension (sustained systolic blood pressure > 150 mmHg or diastolic pressure > 100 mmHg despite optimal medical management);
  • Bowel obstruction or gastric outlet obstruction;
  • Psychiatric illness/social situations that would limit compliance with study requirements;
  • Any medical condition which in the opinion of the Investigator places the subject at an unacceptably high risk for toxicities.
  • Pregnant or lactating.

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

  • Site Reference ID/Investigator# 128815

    Kurume-shi,Fukuoka

  • Site Reference ID/Investigator# 128997

    Morioka

  • Site Reference ID/Investigator# 128058

    Nagaizumi-cho

Other trials in Japan

About this study

Official title: A Phase 1 Study of Veliparib in Combination With Carboplatin And Weekly Paclitaxel in Japanese Subjects With Ovarian Cancer

This is a Phase 1, open-label, multicenter, dose escalation study evaluating the tolerability, safety, pharmacokinetics and preliminary efficacy of veliparib in combination with carboplatin and weekly paclitaxel in Japanese subjects with ovarian cancer.

Conditions
Ovarian Cancer
Being tested
veliparib, carboplatin, paclitaxel
Keywords
ABT-888, BRCA, Primary peritoneal cancer, carboplatin, Fallopian tube, Poly (ADP-ribose) polymerase (PARP), paclitaxel, Ovarian cancer, veliparib
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • veliparibDrug

    Also called ABT-888

    Veliparib will be given orally, twice daily on Days 1-21, every 21 days.

  • carboplatinDrug

    Also called paraplatin

    Carboplatin will be administered on Day 1 of each cycle, intravenously.

  • paclitaxelDrug

    Also called taxol

    Paclitaxel will be administered on Days 1, 8, 15 of each cycle, intravenously.

Study groups in NCT02483104
Study groupRoleWhat they receive
veliparib (ABT-888)ExperimentalNot described
Receives: Drug: veliparib; Drug: carboplatin; Drug: paclitaxel

What is being measured

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

  1. Number of participants with Dose-limiting toxicities

    Measured: During the first cycle (21 days) of veliparib administration

Secondary outcomes (5)

  1. Number of participants with adverse events

    Collect all adverse events at each visit and assess according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03

    Measured: Approximately 5 months

  2. Preliminary tumor response

    According to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1

    Measured: Participants will be evaluated for 5 months.

  3. Maximum observed plasma concentration (Cmax) of Veliparib

    Maximum observed concentration, occurring at Tmax

    Measured: For 24 hours following veliparib dosing.

  4. The time to Cmax (peak time, Tmax) of Veliparib

    The time at which maximum plasma concentration (Cmax) is observed.

    Measured: For 24 hours following veliparib dosing.

  5. The area under the plasma concentration-time curve (AUC) of Veliparib

    Measured: For 24 hours following veliparib dosing.

Timeline

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

  1. First posted26 Jun 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionMar 2016
  4. Study completionJul 2016

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02483104
Sponsor's protocol ID
M14-488
Status last verified
Aug 2016
First submitted
24 Jun 2015
Last updated
20 Nov 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Nishio S, Takekuma M, Takeuchi S, Kawano K, Tsuda N, Tasaki K, Takahashi N, Abe M, Tanaka A, Nagasawa T, Shoji T, Xiong H, Nuthalapati S, Leahy T, Hashiba H, Kiriyama T, Komarnitsky P, Hirashima Y, Ushijima K. Phase 1 study of veliparib with carboplatin and weekly paclitaxel in Japanese patients with newly diagnosed ovarian cancer. Cancer Sci. 2017 Nov;108(11):2213-2220. doi: 10.1111/cas.13381. Epub 2017 Sep 18.

    PubMed 28837250

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing veliparib, carboplatin and paclitaxel in people with Ovarian Cancer, run by AbbVie at 3 sites in Japan.

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 6 inclusion and 18 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 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. 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 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.

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?

Number of participants with Dose-limiting toxicities (time frame: During the first cycle (21 days) of veliparib administration). 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 NCT02483104, 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 20 Nov 2017.

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