Gastrointestinal CancerPhase 2ACT-GINCT05772546
Avatrombopag vs. Placebo for CIT in GI Malignancies
A Phase 2 study testing Avatrombopag in people with Gastrointestinal Cancer and Gastrointestinal Neoplasms, run by Hanny Al-Samkari, MD at 4 sites in United States.
Trial summary
The purpose of this study is to compare the efficacy of two study drugs, Avatrobopag versus placebo, to treat persistent Chemotherapy-Induced Thrombocytopenia (CIT) in patients with gastrointestinal (GI) malignancies receiving cytotoxic chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer, Gastrointestinal Neoplasms, 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
- 49 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Nov 2023to 20 Apr 2026
- Phase
- Phase 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of persistent chemotherapy-induced thrombocytopenia, as defined by a platelet count of <85,000/µL on Day 1 of a chemotherapy cycle.
- Age ≥18 years at the time of informed consent. Because no dosing or adverse event data are currently available on the use of avatrombopag for CIT in participants <18 years of age, children are excluded from this study, but may be eligible for future pediatric trials.
- Receiving cytotoxic chemotherapy for a gastrointestinal malignancy, including esophageal, gastric, small bowel, hepatobiliary (cholangiocarcinoma, gallbladder carcinoma, hepatocellular carcinoma), pancreatic, or colorectal cancer. Lymphomas are not eligible. Patients of any stage are eligible.
- The chemotherapy regimen being used to treat the patient's gastrointestinal malignancy must be administered in 14, 21, or 28-day cycles and include at least one of the following agents: fluorouracil, capecitabine, floxuridine, trifluridine/tipiracil, gemcitabine, cisplatin, carboplatin, oxaliplatin, irinotecan, liposomal irinotecan, paclitaxel, nanoalbumin-bound paclitaxel, docetaxel, epirubicin, or doxorubicin.
- A plan to continue the current chemotherapy regimen (the regimen that resulted in CIT) at the same dose and schedule for at least 1 more cycle if the platelet count is adequate (>100,000/µL).
- Participant has not received cytotoxic chemotherapy in the 13 days before study Day 1, except for infusional fluorouracil in regimens with a 14-day cycle length or oral cytotoxic chemotherapy agents. .
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- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (see Appendix B) and a life expectancy of >12 weeks at screening.
- Participants must have adequate organ and marrow function as defined below. Use of standard-of-care G-CSF and/or red cell transfusions to achieve adequate ANC and hemoglobin levels is allowed.
- Absolute neutrophil count (ANC) ≥500/µL
- Hemoglobin ≥8 g/dL
- AST (SGOT) and ALT (SGPT) ≤5 × institutional ULN
- Total bilirubin ≤3 × institutional ULN
- The effects of avatrombopag on the developing human fetus are unknown. For this reason, women of child-bearing potential and men (except for a vasectomized man with confirmed azoospermia) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for the 30 days after discontinuation of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Participant is willing and able to comply with the study protocol.
- Ability to understand and the willingness to sign a written informed consent document, unless the participant lacks capacity to provide consent, in which case a legally authorized representative (LAR) gives permission for the participant to participate.
Who cannot join
- Participant has a history of hematologic malignancy, including leukemia, lymphoma, myeloma, myelodysplastic syndrome, or a myeloproliferative neoplasm, with the exception of a non-clinically significant neoplasm in the judgement of the investigator (e.g., indolent B-cell neoplasm not requiring treatment, monoclonal gammopathy of undetermined significance, etc.).
- Participant has known bone marrow invasion by tumor or multiple (greater than 1) bony metastatic lesions. Participants do not need to undergo screening with bone marrow biopsy or imaging to satisfy this criterion.
- Participant has received prior irradiation directly to the pelvic bones of a dose of >20 Gy.
- Participants with a history of a prior major venous thromboembolic event, such as a deep vein thrombosis or pulmonary embolism, or symptomatic arterial thrombotic events such as a myocardial infarction, ischemic cerebral vascular accident or transient ischemic attack will be ineligible if they have not tolerated anticoagulation therapy. If patients remain on anticoagulation or have completed the prescribed course of anticoagulation, they will be eligible for enrollment. A venous thrombotic event associated with a central venous catheter or a superficial venous thrombosis will not make the patient ineligible.
- Participant has spontaneous recovery of the platelet count to >100,000/µL prior to randomization.
- Participant has any known clinically significant acute or active bleeding (e.g. gastrointestinal or central nervous system) within 7 days prior to consent.
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- Participants who are receiving any other investigational agents or have received any other investigational agent within 30 days of study Day 1.
- History of hypersensitivity reactions to avatrombopag or any of its excipients.
- Participants with uncontrolled intercurrent illness, in the opinion of the investigator.
- Participants with psychiatric illness/social situations that would limit compliance with study requirements, in the opinion of the investigator.
- Pregnant women are excluded from this study because the effect of avatrombopag on the developing fetus are unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with avatrombopag, breastfeeding should be discontinued if the mother is treated with avatrombopag. Pregnancy status will be assessed with a serum B-HCG pregnancy test in women of child-bearing potential (see Section 10 for timing). Women who are menopausal or perimenopausal will have follicle-stimulating hormone levels drawn to confirm menopausal status.
- Participant has received a platelet transfusion within 3 days of study Day 1.
- Participant is unable to take oral medication.
- Participant has received a thrombopoietin receptor agonist (romiplostim, eltrombopag, avatrombopag, or lusutrombopag) for any reason within 14 days of study Day 1.
- Participant has a history of active chronic platelet disorders or thrombocytopenia due to an etiology other than CIT, in the opinion of the investigator.
- Any other medical condition or factor that, in the opinion of the investigator, is likely to interfere with completion of the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Oregon Health and Science University Hospital
Portland, Oregon, 97239
University of Washington Fred Hutchinson Cancer Center
Seattle, Washington, 98195
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Avatrombopag for Persistent Chemotherapy-Induced Thrombocytopenia in Patients With Gastrointestinal Malignancies (ACT-GI)
The purpose of this study is to compare the efficacy of two study drugs, Avatrobopag versus placebo, to treat persistent Chemotherapy-Induced Thrombocytopenia (CIT) in patients with gastrointestinal (GI) malignancies receiving cytotoxic chemotherapy.
The names of the study drugs involved in this study are:
- Avatrombopag (a thrombopoietin receptor agonist)
- Matching placebo
Read the detailed description
This is a randomized, double-blinded, placebo-controlled, multicenter phase 2 clinical trial evaluating Avatrombopag versus placebo for Chemotherapy-Induced Thrombocytopenia (CIT) in patients with gastrointestinal (GI) malignancies. Avatrombopag may increase or stimulate megakaryocytes, which aid in producing blood platelets, resulting in an increased production of platelets.
- Participants will be "randomized" into one of the study groups: Group A: Avatrombopag or Group B: Matching placebo. Randomization means that a participant is put into a group by chance.
- All patients who complete the study (whether they received avatrombopag or placebo) have the opportunity to receive avatrombopag to treat CIT through a special free drug program available only to the participants of this study.
The U.S. Food and Drug Administration (FDA) has not approved avatrombopag for CIT, but it has been approved for other uses.
Study procedures include screening for eligibility, treatment visits, and blood tests.
Participants will receive the study treatment or placebo for up to seven weeks and will be followed for up to 42 days after the last dose.
It is expected that about 60 people will take part in this research study.
Swedish Orphan Biovitrum (Sobi), biopharmaceutical company, is supporting this research study by providing the study drugs and funding.
- Conditions
- Gastrointestinal Cancer, Gastrointestinal Neoplasms, Chemotherapy-Induced Thrombocytopenia
- Being tested
- Avatrombopag, Matching Placebo
- Keywords
- Chemotherapy-Induced Thrombocytopenia, CIT, Gastrointestinal Malignancies, Gastrointestinal Cancer, Gastrointestinal Neoplasms, Avatrombopag, Thrombopoietin, Thrombopoietin receptor agonist
- Medical subject headings
- Gastrointestinal Neoplasms, Jacobs syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvatrombopagDrug
Also called Doptelet, avatrombopag maleate
Thrombopoietin receptor agonist, tablet taken orally.
Matching PlaceboDrug
Lactose monohydrate, tablet taken orally.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Avatromopag | Experimental | 30 participants will be randomized into a 1:1 fashion and will be stratified based on the number of cytotoxic agents in the patient's chemotherapy regimen. Participants will complete study procedures as outlined:
Lead-In Period (Day 1 - 15)
* Pre-determined dose of Avatrombopag 1x daily.
* Participants failing to achieve a platelet count ≥100,000/µL within 2 weeks will be considered a treatment failure (and will proceed to the end-of-study visit).
On-Cycle Period (Day 15 - up to Week 6)
• Pre-determined dose of Avatrombopag 1x daily.
Follow-up Period
* End of Treatment on-site visit.
* Follow-up visit 30-42 days after End of Treatment visit. Receives: Drug: Avatrombopag |
| Group B - Matching Placebo | Active comparator | 30 participants will be randomized into a 1:1 fashion and will be stratified based on the number of cytotoxic agents in the patient's chemotherapy regimen. Participants will complete study procedures as outlined:
Lead-In Period (Day 1 - 15)
* Pre-determined dose of matching placebo 1x daily.
* Participants failing to achieve a platelet count ≥100,000/µL within 2 weeks will be considered a treatment failure (and will proceed to the end-of-study visit).
On-Cycle Period (Day 15 - up to Week 6)
• Pre-determined dose of matching placebo 1x daily.
Follow-up Period
* End of Treatment on-site visit.
* Follow-up visit 30-42 days after End of Treatment visit. Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
The primary endpoint of this study is the comparison of the response rate between the avatrombopag arm and the placebo arm. A response is defined as achieving a platelet count ≥100,000/µL within the 2 week lead-in period and then finishing at least 1 cycle of chemotherapy without CIT recurrence (no on-cycle dose-reduction or treatment delay due to thrombocytopenia and ability to receive another cycle of chemotherapy without dose-reduction or treatment delay, defined as platelet count of ≥100,000/µL at the start of the following cycle whether or not an additional cycle is planned).
Measured: Up to 6 weeks
Response Rate of CIT Treatment in Avatrombopag
Defined as the composite of successful initial platelet count recovery to ≥100,000/µL within 15 days of initiation of study drug, plus CIT prevention for one additional chemotherapy cycle (including at the completion of that cycle/start of the following cycle).
Measured: Up to 6 weeks
Response Rate of CIT Treatment in Placebo Group
Defined as the composite of successful initial platelet count recovery to ≥100,000/µL within 15 days of initiation of study drug, plus CIT prevention for one additional chemotherapy cycle (including at the completion of that cycle/start of the following cycle).
Measured: Up to 6 weeks
Secondary outcomes (10)
Proportion of Platelet Count Recovery in Avatrombopag Group
Assessed by the rate of initial platelet count recovery to ≥100,000/µL during the lead-in period
Measured: At baseline, days 8 +/-1 and 15 +/-1
Proportion of Platelet Count Recovery in Placebo Group
Assessed by the rate of initial platelet count recovery to ≥100,000/µL during the lead-in period.
Measured: At baseline, days 8 +/-1 and 15 +/-1
Requirement of Platelet Transfusions in Avatrombopag Group
The decision on platelet transfusion could be made either because the patient's platelet count is below a threshold, or due to physician's decision. The probability of patients requiring platelet transfusion will be estimated with a 95% confidence interval.
Measured: Day 1 to 30 days post-treatment discontinuation
Requirement of Platelet Transfusions in Placebo Group
The decision on platelet transfusion could be made either because the patient's platelet count is below a threshold, or due to physician's decision. The probability of patients requiring platelet transfusion will be estimated with a 95% confidence interval.
Measured: Day 1 to 30 days post-treatment discontinuation
Rate of Clinically Relevant Bleeding Events in Avatrombopag Group
The rate of clinically relevant bleeding will be estimated by the Kaplan-Meier curve. Bleeding events will be graded according to CTCAE and according to the modified WHO bleeding scale. Clinically significant bleeding events will be considered grade II-IV events per this scale.
Measured: Day 1 to 30 days post-treatment discontinuation
Rate of Clinically Relevant Bleeding Events in Placebo Group
The rate of clinically relevant bleeding will be estimated by the Kaplan-Meier curve. Bleeding events will be graded according to CTCAE and according to the modified WHO bleeding scale. Clinically significant bleeding events will be considered grade II-IV events per this scale.
Measured: Day 1 to 30 days post-treatment discontinuation
Rate of Thromboembolic Events in Avatrombopag Group
Thromboembolic events will be graded per CTCAE.
Measured: Day 1 to 30 days post-treatment discontinuation
Rate of Thromboembolic Events in Placebo Group
Thromboembolic events will be graded per CTCAE.
Measured: Day 1 to 30 days post-treatment discontinuation
Rate of Serious Treatment-Emergent Adverse Events (TEAEs) in Avatromobopag Group
TEAEs will be graded per CTCAE.
Measured: Day 1 to 30 days post-treatment discontinuation
Rate of Serious Treatment-Emergent Adverse Events (TEAEs) in Placebo Group
TEAEs will be graded per CTCAE.
Measured: Day 1 to 30 days post-treatment discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Nov 2023
- Primary completion2 Jan 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanny Al-Samkari, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Orphan Biovitrum
- Responsible party
- Sponsor-investigator, Hanny Al-Samkari, MD, Massachusetts General Hospital
- Investigators
- Hanny Al-Samkari, MD, Principal investigator, Massachusetts General HospitalGerald A Soff, MD, Principal investigator, University of Miami Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772546
- Sponsor's protocol ID
- 22-712
- Acronym
- ACT-GI
- Status last verified
- Aug 2026
- First submitted
- 6 Mar 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Al-Samkari H, Shatzel JJ, Panch SR, Keating JH, Walsh EP, Weekes CD, Kardosh A, Cohen SA, Cohen JJ, Hodges PG, Dhaver SE, Strojny N, Donovan C, Belibasakis C, Soff GA. Avatrombopag Versus Placebo for Persistent Chemotherapy-Induced Thrombocytopenia in GI Cancers: The Phase II ACT-GI Trial. J Clin Oncol. 2026 Nov;44(31):3006-3014. doi: 10.1200/JCO-26-00568. Epub 2026 Jul 13.
PubMed 42441933
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Avatrombopag for Persistent Chemotherapy-Induced Thrombocytopenia in Patients With Gastrointestinal Malignancies (ACT-GI)
- ClinicalTrials.gov ID
- NCT05772546
- Acronym / sponsor ID
- ACT-GI / 22-712
- Conditions
- Gastrointestinal Cancer, Gastrointestinal Neoplasms, Chemotherapy-Induced Thrombocytopenia
- Keywords
- Chemotherapy-Induced Thrombocytopenia, CIT, Gastrointestinal Malignancies, Gastrointestinal Cancer, Gastrointestinal Neoplasms, Avatrombopag, Thrombopoietin, Thrombopoietin receptor agonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Hanny Al-Samkari, MDUniversity, hospital or other
- Collaborators
- Swedish Orphan Biovitrum
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 2 Jan 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy of two study drugs, Avatrobopag versus placebo, to treat persistent Chemotherapy-Induced Thrombocytopenia (CIT) in patients with gastrointestinal (GI) malignancies receiving cytotoxic chemotherapy.
The names of the study drugs involved in this study are:
- Avatrombopag (a thrombopoietin receptor agonist)
- Matching placebo
Detailed description
This is a randomized, double-blinded, placebo-controlled, multicenter phase 2 clinical trial evaluating Avatrombopag versus placebo for Chemotherapy-Induced Thrombocytopenia (CIT) in patients with gastrointestinal (GI) malignancies. Avatrombopag may increase or stimulate megakaryocytes, which aid in producing blood platelets, resulting in an increased production of platelets.
- Participants will be "randomized" into one of the study groups: Group A: Avatrombopag or Group B: Matching placebo. Randomization means that a participant is put into a group by chance.
- All patients who complete the study (whether they received avatrombopag or placebo) have the opportunity to receive avatrombopag to treat CIT through a special free drug program available only to the participants of this study.
The U.S. Food and Drug Administration (FDA) has not approved avatrombopag for CIT, but it has been approved for other uses.
Study procedures include screening for eligibility, treatment visits, and blood tests.
Participants will receive the study treatment or placebo for up to seven weeks and will be followed for up to 42 days after the last dose.
It is expected that about 60 people will take part in this research study.
Swedish Orphan Biovitrum (Sobi), biopharmaceutical company, is supporting this research study by providing the study drugs and funding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Avatromopag | Experimental | Drug: Avatrombopag30 participants will be randomized into a 1:1 fashion and will be stratified based on the number of cytotoxic agents in the patient's chemotherapy regimen. Participants will complete study procedures as outlined: Lead-In Period (Day 1 - 15) * Pre-determined dose of Avatrombopag 1x daily. * Participants failing to achieve a platelet count ≥100,000/µL within 2 weeks will be considered a treatment failure (and will proceed to the end-of-study visit). On-Cycle Period (Day 15 - up to Week 6) • Pre-determined dose of Avatrombopag 1x daily. Follow-up Period * End of Treatment on-site visit. * Follow-up visit 30-42 days after End of Treatment visit. |
| Group B - Matching Placebo | Active comparator | Drug: Matching Placebo30 participants will be randomized into a 1:1 fashion and will be stratified based on the number of cytotoxic agents in the patient's chemotherapy regimen. Participants will complete study procedures as outlined: Lead-In Period (Day 1 - 15) * Pre-determined dose of matching placebo 1x daily. * Participants failing to achieve a platelet count ≥100,000/µL within 2 weeks will be considered a treatment failure (and will proceed to the end-of-study visit). On-Cycle Period (Day 15 - up to Week 6) • Pre-determined dose of matching placebo 1x daily. Follow-up Period * End of Treatment on-site visit. * Follow-up visit 30-42 days after End of Treatment visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- A diagnosis of persistent chemotherapy-induced thrombocytopenia, as defined by a platelet count of <85,000/µL on Day 1 of a chemotherapy cycle.
- Age ≥18 years at the time of informed consent. Because no dosing or adverse event data are currently available on the use of avatrombopag for CIT in participants <18 years of age, children are excluded from this study, but may be eligible for future pediatric trials.
- Receiving cytotoxic chemotherapy for a gastrointestinal malignancy, including esophageal, gastric, small bowel, hepatobiliary (cholangiocarcinoma, gallbladder carcinoma, hepatocellular carcinoma), pancreatic, or colorectal cancer. Lymphomas are not eligible. Patients of any stage are eligible.
- The chemotherapy regimen being used to treat the patient's gastrointestinal malignancy must be administered in 14, 21, or 28-day cycles and include at least one of the following agents: fluorouracil, capecitabine, floxuridine, trifluridine/tipiracil, gemcitabine, cisplatin, carboplatin, oxaliplatin, irinotecan, liposomal irinotecan, paclitaxel, nanoalbumin-bound paclitaxel, docetaxel, epirubicin, or doxorubicin.
- A plan to continue the current chemotherapy regimen (the regimen that resulted in CIT) at the same dose and schedule for at least 1 more cycle if the platelet count is adequate (>100,000/µL).
Key exclusion criteria (16 listed)
- Participant has a history of hematologic malignancy, including leukemia, lymphoma, myeloma, myelodysplastic syndrome, or a myeloproliferative neoplasm, with the exception of a non-clinically significant neoplasm in the judgement of the investigator (e.g., indolent B-cell neoplasm not requiring treatment, monoclonal gammopathy of undetermined significance, etc.).
- Participant has known bone marrow invasion by tumor or multiple (greater than 1) bony metastatic lesions. Participants do not need to undergo screening with bone marrow biopsy or imaging to satisfy this criterion.
- Participant has received prior irradiation directly to the pelvic bones of a dose of >20 Gy.
- Participants with a history of a prior major venous thromboembolic event, such as a deep vein thrombosis or pulmonary embolism, or symptomatic arterial thrombotic events such as a myocardial infarction, ischemic cerebral vascular accident or transient ischemic attack will be ineligible if they have not tolerated anticoagulation therapy. If patients remain on anticoagulation or have completed the prescribed course of anticoagulation, they will be eligible for enrollment. A venous thrombotic event associated with a central venous catheter or a superficial venous thrombosis will not make the patient ineligible.
- Participant has spontaneous recovery of the platelet count to >100,000/µL prior to randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvatrombopagAlso: Doptelet, avatrombopag maleateThrombopoietin receptor agonist, tablet taken orally. | Drug | Group A - Avatromopag |
| Matching PlaceboLactose monohydrate, tablet taken orally. | Drug | Group B - Matching Placebo |
Primary outcome
Response Rate
Time frame: Up to 6 weeks
The primary endpoint of this study is the comparison of the response rate between the avatrombopag arm and the placebo arm. A response is defined as achieving a platelet count ≥100,000/µL within the 2 week lead-in period and then finishing at least 1 cycle of chemotherapy without CIT recurrence (no on-cycle dose-reduction or treatment delay due to thrombocytopenia and ability to receive another cycle of chemotherapy without dose-reduction or treatment delay, defined as platelet count of ≥100,000/µL at the start of the following cycle whether or not an additional cycle is planned).
Response Rate of CIT Treatment in Avatrombopag
Time frame: Up to 6 weeks
Defined as the composite of successful initial platelet count recovery to ≥100,000/µL within 15 days of initiation of study drug, plus CIT prevention for one additional chemotherapy cycle (including at the completion of that cycle/start of the following cycle).
Response Rate of CIT Treatment in Placebo Group
Time frame: Up to 6 weeks
Defined as the composite of successful initial platelet count recovery to ≥100,000/µL within 15 days of initiation of study drug, plus CIT prevention for one additional chemotherapy cycle (including at the completion of that cycle/start of the following cycle).
10 secondary outcomes
Proportion of Platelet Count Recovery in Avatrombopag Group
Time frame: At baseline, days 8 +/-1 and 15 +/-1
Proportion of Platelet Count Recovery in Placebo Group
Time frame: At baseline, days 8 +/-1 and 15 +/-1
Requirement of Platelet Transfusions in Avatrombopag Group
Time frame: Day 1 to 30 days post-treatment discontinuation
Requirement of Platelet Transfusions in Placebo Group
Time frame: Day 1 to 30 days post-treatment discontinuation
Rate of Clinically Relevant Bleeding Events in Avatrombopag Group
Time frame: Day 1 to 30 days post-treatment discontinuation
Rate of Clinically Relevant Bleeding Events in Placebo Group
Time frame: Day 1 to 30 days post-treatment discontinuation
Rate of Thromboembolic Events in Avatrombopag Group
Time frame: Day 1 to 30 days post-treatment discontinuation
Rate of Thromboembolic Events in Placebo Group
Time frame: Day 1 to 30 days post-treatment discontinuation
Rate of Serious Treatment-Emergent Adverse Events (TEAEs) in Avatromobopag Group
Time frame: Day 1 to 30 days post-treatment discontinuation
Rate of Serious Treatment-Emergent Adverse Events (TEAEs) in Placebo Group
Time frame: Day 1 to 30 days post-treatment discontinuation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Derived from this study: PubMed 42441933Al-Samkari H, Shatzel JJ, Panch SR, Keating JH, Walsh EP, Weekes CD, Kardosh A, Cohen SA, Cohen JJ, Hodges PG, Dhaver SE, Strojny N, Donovan C, Belibasakis C, Soff GA. Avatrombopag Versus Placebo for Persistent Chemotherapy-Induced Thrombocytopenia in GI Cancers: The Phase II ACT-GI Trial. J Clin Oncol. 2026 Nov;44(31):3006-3014. doi: 10.1200/JCO-26-00568. Epub 2026 Jul 13.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanny Al-Samkari, MD principal investigator
Massachusetts General Hospital
Gerald A Soff, MD principal investigator
University of Miami Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avatrombopag in people with Gastrointestinal Cancer and Gastrointestinal Neoplasms, run by Hanny Al-Samkari, MD at 4 sites in United States.
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 15 inclusion and 16 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 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 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?
Response Rate (time frame: Up to 6 weeks). The study lists 3 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 NCT05772546, 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 31 Aug 2026.