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Chemotherapy-induced ThrombocytopeniaPhase 3NCT03471078

Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers

A Phase 3 study testing Avatrombopag in people with Chemotherapy-induced Thrombocytopenia, run by Sobi, Inc. at 55 sites in 7 countries.

Completed

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

Official record
Search all trials

Trial summary

Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of avatrombopag in subjects with chemotherapy-induced thrombocytopenia receiving chemotherapy for the treatment of ovarian, lung (small cell and non-small cell) and bladder cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chemotherapy-induced Thrombocytopenia
What is being tested?
Avatrombopag
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
122 participants
Where
55 sitesin 7 countries
Study dates
12 Oct 2018to 31 Jan 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women greater than or equal to 18 years of age;
  • A diagnosis of ovarian, lung (small cell or non-small cell) or bladder cancer requiring systemic chemotherapy
  • Participant receiving a chemotherapy regimen given in a 21 or 28-day cycle, including 1 or more of the following agents or class of agents:
  • Nucleoside analog, including gemcitabine and fluorouracil;
  • Carboplatin or cisplatin;
  • Anthracycline; or
Show all 9Show fewer
  • Alkylating agent;
  • Participant experienced severe thrombocytopenia, defined as 2 platelet counts <50 x 109/L measured at least 24 hours apart, during the qualifying chemotherapy cycle, of their current chemotherapy regimen
  • ECOG performance status <=2

Who cannot join

  • Participant has experienced >=Grade 2 CIT other than during the current chemotherapy treatment regimen within 6 months of Screening;
  • Participant has any history of hematologic malignancies, including leukemia, myeloma, myeloproliferative disease, lymphoma, or myelodysplastic diseases;
  • Participant has received >2 previous lines of chemotherapy or is receiving whole brain radiation during the study treatment period;
  • Participant has a known medical history of genetic prothrombotic syndromes
  • Participant has a history of arterial or venous thrombosis within 3 months of screening;
  • Use of vitamin K antagonists;
  • Participant has previously received a thrombopoietin receptor agonist or recombinant human thrombopoietin for the treatment of CIT within 3 months of screening

Trial locations and contacts

55 sites in 7 countries.

55 sites in 7 countries

United States14 sites

  • Dova Site

    Anaheim, California, 92801

  • Dova Site

    Ashland, Kentucky, 41101

  • Dova Site

    Augusta, Georgia, 30912

  • Dova Site

    Bakersfield, California, 93309

  • Dova Site

    Bloomington, Indiana, 47403

  • Dova Site

    Boston, Massachusetts, 02114

  • Dova Site

    Canton, Ohio, 44718

  • Dova Site

    Gettysburg, Pennsylvania, 17325

  • Dova Site

    Harvey, Illinois, 60426

  • Dova Site

    Minneapolis, Minnesota, 55417

  • Dova Site

    Riverside, California, 92501

  • Dova Site

    Santa Monica, California, 90403

  • Dova Site

    Skokie, Illinois, 60076

  • Dova Site

    Wichita, Kansas, 67214

Other trials in United States

Ukraine13 sites

  • Dova Site

    Cherkasy

  • Dova Site

    Chernihiv

  • Dova Site

    Chernivtsi

  • Dova Site

    Ivano-Frankivsk

  • Dova Site

    Kharkiv

  • Dova Site

    Kherson

  • Dova Site

    Kropyvnytskyi

  • Dova Site

    Kyiv

  • Dova Site

    Odesa

  • Dova Site

    Sumy

  • Dova Site

    Ternopil

  • Dova Site

    Uzhhorod

  • Dova Site

    Vinnytsia

Other trials in Ukraine

Russia11 sites

  • Dova Site

    Arkhangelsk

  • Dova Site

    Kazan'

  • Dova Site

    Kursk

  • Dova Site

    Moscow

  • Dova Site

    Novosibirsk

  • Dova Site

    Omsk

  • Dova Site

    Pyatigorsk, 357502

  • Dova Site

    Saint Petersburg, 188663

  • Dova Site

    Saint Petersburg

  • Dova Site

    Saransk

  • Dova Site

    Sochi

Other trials in Russia

China5 sites

  • Dova Site

    Harbin

  • Dova Site

    Linyi

  • Dova Site

    Neijiang

  • Dova Site

    Shanghai

  • Dova Site

    Tianjin

Other trials in China

Poland5 sites

  • Dova Site

    Lublin

  • Dova Site

    Olsztyn

  • Dova Site

    Prabuty

  • Dova Site

    Tomaszów Mazowiecki

  • Dova Site

    Warsaw

Other trials in Poland

Hungary4 sites

  • Dova Site

    Budapest

  • Dova Site

    Debrecen

  • Dova Site

    Nyíregyháza

  • Dova Site

    Törökbálint

Other trials in Hungary

Serbia3 sites

  • Dova Site

    Belgrade

  • Dova Site

    Kamenitz

  • Dova Site

    Kragujevac

Other trials in Serbia

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled Study With Open-Label Extension to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Active Non-Hematological Cancers

Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of avatrombopag in subjects with chemotherapy-induced thrombocytopenia receiving chemotherapy for the treatment of ovarian, lung (small cell and non-small cell) and bladder cancer.

Read the detailed description

Subjects will receive placebo controlled test treatment for one cycle of chemotherapy followed by an observational cycle. Subjects will have the option to continue into an open label extension period for all remaining chemotherapy cycles within the current regimen. After the follow-up visit, all subjects will continue to a long-term safety follow-up period.

Being tested
Avatrombopag, Placebo Oral Tablet
Keywords
CIT, Thrombocytopenia
Medical subject headings
Thrombocytopenia

What participants receive

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

  • AvatrombopagDrug

    Oral avatrombopag tablet

  • Placebo Oral TabletDrug

    Placebo comparator tablet

Study groups in NCT03471078
Study groupRoleWhat they receive
AvatrombopagExperimentalStudy is 2:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment.
Receives: Drug: Avatrombopag
PlaceboPlacebo comparatorStudy is 2:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment.
Receives: Drug: Placebo Oral Tablet

What is being measured

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

  1. Percentage of Subjects Who do Not Require Platelet Transfusion, Dose Reduction in Chemotherapy by 15%, or Chemotherapy Delay by >=4 Days

    Measured: Randomization up to 33 days

Secondary outcomes (3)

  1. Duration of Severe Thrombocytopenia Defined as a Platelet Count <50 x 10^9/L

    The duration of severe thrombocytopenia is defined as the total number of days with a platelet count <50×10^9/L during the period after post-chemotherapy study drug treatment in Cycle X+1 through Chemotherapy Day of Cycle X+2.

    Measured: Randomization up to 33 days

  2. Change in Platelet Count From Baseline (Nadir)

    Comparison of avatrombopag 60 mg vs. placebo, adjusted for the number of chemotherapy agents currently receiving per IWRS (1, ≥2).

    Cycle X nadir is defined as the lowest platelet count value prior to the first dose of study drug; Cycle X+1 nadir is defined as the lowest platelet count value during the period after post-chemotherapy study drug treatment in Cycle X+1 through Chemotherapy Day in Cycle X+2.

    Measured: Randomization up to 33 days

  3. Percentage of Subjects Who Did Not Have Major or Non-major Clinically Relevant Bleeding During the Period After Post-chemotherapy Study Drug Treatment in Cycle X+1 Through Chemotherapy Day of Cycle X+2.

    Measured: Randomization up to 33 days

Timeline

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

  1. First posted20 Mar 2018
  2. Study start12 Oct 2018
  3. Primary completion28 Aug 2020
  4. Study completion31 Jan 2023

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 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03471078
Sponsor's protocol ID
AVA-CIT-330
Status last verified
Sep 2023
First submitted
7 Mar 2018
Last updated
28 Sep 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Al-Samkari H, Kolb-Sielecki J, Safina SZ, Xue X, Jamieson BD. Avatrombopag for chemotherapy-induced thrombocytopenia in patients with non-haematological malignancies: an international, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Haematol. 2022 Mar;9(3):e179-e189. doi: 10.1016/S2352-3026(22)00001-1.

    PubMed 35240074

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Avatrombopag in people with Chemotherapy-induced Thrombocytopenia, run by Sobi, Inc. at 55 sites in 7 countries.

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 9 inclusion and 7 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Ukraine, Russia, China, Poland and 2 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Subjects Who do Not Require Platelet Transfusion, Dose Reduction in Chemotherapy by 15%, or Chemotherapy Delay by >=4 Days (time frame: Randomization up to 33 days). 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 NCT03471078, 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 28 Sep 2023.

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