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Locally Advanced or Metastatic Solid TumorPhase 1/2NCT03601897

A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced or Metastatic Solid Tumors

A Phase 1/2 study testing Rebastinib and Paclitaxel in people with Locally Advanced or Metastatic Solid Tumor, run by Deciphera Pharmaceuticals, LLC at 14 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with paclitaxel designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in patients with advanced or metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rebastinib and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
177 participants
Where
14 sitesUnited States
Study dates
25 Oct 2018to 23 May 2022
Phase
Phase 1/2
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

  • Male or female patients ≥18 years of age at the time of informed consent
  • Part 1 Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor for which paclitaxel is considered appropriate treatment
  • Part 2
  • Triple-negative and Stage IV inflammatory breast cancer
  • Recurrent ovarian cancer
  • Recurrent, metastatic or high-risk endometrial cancer
Show all 13Show fewer
  • Advanced (stage III or IV), or recurrent gynecological carcinosarcoma
  • Homologous or heterologous type carcinosarcoma (malignant mixed Mullerian tumor [MMMT] allowed
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of ≤2
  • Able to provide an archival tumor tissue sample
  • Adequate organ function and bone marrow reserve
  • If a female of childbearing potential, must have a negative pregnancy test prior to enrollment
  • Patient must provide signed consent to participate in the study and is willing to comply with study-specific procedures

Who cannot join

  • Received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose
  • Not recovered from prior-treatment toxicities to Grade ≤1
  • Peripheral neuropathy of any etiology >Grade 1
  • Concurrent malignancy
  • Known active central nervous system (CNS) metastases
  • Use of systemic corticosteroids
Show all 20Show fewer
  • Known retinal neovascularization, macular edema or macular degeneration
  • History or presence of clinically relevant cardiovascular abnormalities
  • QT interval corrected by Fridericia's formula (QTcF) >450 ms in males or >470 ms in females
  • Left ventricular ejection fraction (LVEF) <50% at screening
  • Arterial thrombotic or embolic events
  • Venous thrombotic event
  • Active infection ≥Grade 3
  • Human immunodeficiency virus (HIV) or hepatitis C (HCV) infection only if taking medications excluded per protocol, active hepatitis B (HBV), or active HCV infection
  • Use of proton pump inhibitors
  • If female, the patient is pregnant or lactating
  • Major surgery 4 weeks prior to the first dose of study drug
  • Malabsorption syndrome or other illness which could affect oral absorption
  • Known allergy or hypersensitivity to any component of rebastinib or any of its excipients.
  • Any other clinically significant comorbidities

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • University of Colorado Denver- Anschutz Medical Center

    Aurora, Colorado, 80045

  • University of Alabama Comprehensive Cancer Center

    Birmingham, Alabama, 35233

  • Dana-Farber

    Boston, Massachusetts, 02215

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Oncology Consultants- Texas Medical Center

    Houston, Texas, 77030

  • The University of Kansas Clinical Research Center

    Kansas City, Kansas, 66160

  • Northwell Health/Monter Cancer Center

    Lake Success, New York, 11042

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Women & Infants Hospital

    Providence, Rhode Island, 02905

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

About this study

Official title: An Open-Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced or Metastatic Solid Tumors

This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with paclitaxel designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in patients with advanced or metastatic solid tumors.

Being tested
Rebastinib, Paclitaxel
Keywords
rebastinib, paclitaxel, breast cancer, ovarian cancer, endometrial cancer, gynecological carcinosarcoma, malignant mixed Mullerian tumor (MMMT)
Medical subject headings
Neoplasm Metastasis, Breast Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms, Carcinosarcoma

What participants receive

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

  • RebastinibDrug

    Also called DCC-2036

    Administered orally

  • PaclitaxelDrug

    Paclitaxel administered by IV infusion at 80 mg/m^2

Study groups in NCT03601897
Study groupRoleWhat they receive
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2ExperimentalDose escalation of rebastinib 50 milligram (mg) twice daily (BID) orally (PO) in combination with paclitaxel administered by intravenous (IV) infusion at 80 mg/meter squared (m^2) on days 1, 8, and 15 of repeated 28-day cycles.
Receives: Drug: Rebastinib; Drug: Paclitaxel
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2ExperimentalDose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Receives: Drug: Rebastinib; Drug: Paclitaxel
Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2ExperimentalDose expansion in triple-negative breast cancer (TNBC). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Receives: Drug: Rebastinib; Drug: Paclitaxel
Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2ExperimentalDose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Receives: Drug: Rebastinib; Drug: Paclitaxel
Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2ExperimentalDose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Receives: Drug: Rebastinib; Drug: Paclitaxel
Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2ExperimentalDose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Receives: Drug: Rebastinib; Drug: Paclitaxel
Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2ExperimentalDose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 repeated 28-day cycles.
Receives: Drug: Rebastinib; Drug: Paclitaxel
Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2ExperimentalDose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Receives: Drug: Rebastinib; Drug: Paclitaxel
Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2ExperimentalDose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Receives: Drug: Rebastinib; Drug: Paclitaxel
Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2ExperimentalDose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Receives: Drug: Rebastinib; Drug: Paclitaxel
Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2ExperimentalDose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Receives: Drug: Rebastinib; Drug: Paclitaxel

What is being measured

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

  1. Number of Participants With Adverse Events

    Number of participants (pts) who experienced serious adverse events (SAE) and adverse events (AE).

    Measured: Baseline up to 2.89 years

  2. Objective Response Rate (ORR) (Part 2 Expansion)

    Percentage of participants who achieved an objective response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline, or the appearance of one or more new lesions.

    Measured: Baseline to PD or Death due to Any Cause (Up to 1.54 years)

Secondary outcomes (7)

  1. Objective Response Rate (ORR) (Part 1 Escalation)

    Percentage of pts who achieved an objective response of Complete Response (CR) or Partial Response (PR). Per RECIST v1.1, CR defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to have reduction in short axis to <10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or the appearance of one or more new lesions. Modified RECIST (mRECIST) used for pleural mesothelioma defines CR as the disappearance of any intratumoural arterial enhancement in all target lesions; PR as at least a 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions; PD as an increase of at least 20% in the sum of the diameters of viable target les

    Measured: Baseline to PD or Death due to Any Cause (Up to 0.92 years)

  2. Duration of Response (DOR)

    Time from CR or PR to the earliest documented evidence of PD or death due to any cause. Per RECIST v1.1, CR defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to have reduction in short axis to <10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or the appearance of one or more new lesions. mRECIST used for pleural mesothelioma defines CR as the disappearance of any intratumoural arterial enhancement in all target lesions; PR as at least a 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions; PD as an increase of at least 20% in the sum of the diameters of viable target lesions.

    Measured: Time from CR or PR to PD or Death due to Any Cause (Up to 1.54 years)

  3. Time to Progression (TTP)

    Time from first dose of study drug to the earliest documented evidence of PD. Per RECIST v1.1, PD defined as at least a 20% increase in the sum of the disease measurements for measurable lesions, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions. mRECIST used for pleural mesothelioma defines PD as an increase of at least 20% in the sum of the diameters of viable target lesions.

    Measured: First Dose of Study Drug to PD (Up to 2.61 years)

  4. Progression-free-survival (PFS)

    Time from first dose of study drug to the earliest documented evidence of PD or death due to any cause. Participants who undergo surgical resection of target or non-target lesions, who have received other anticancer treatments, including surgical resection or radiation (other than palliative radiation to pre-existing bone metastases'), or who do not have a documented date of progression or death due to any cause will be censored at the date of the last assessment. PD per RECIST v1.1 is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions. mRECIST used for pleural mesothelioma defines PD as an increase of at least 20% in the sum of the diameters of viable target lesions.

    Measured: First Dose of Study Drug to PD or Death due to Any Cause (Up to 2.61 years)

  5. Overall Survival (OS)

    Time from first dose of study drug to date of death due to any cause. Participants who were still alive or who were lost to follow-up will be censored at the date of last contact.

    Measured: First Dose of Study Drug to Death due to Any Cause (Up to 2.82 years)

  6. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Rebastinib (Part 1)

    Measure the Cmax

    Measured: Part 1: Cycle 1 Day 1 (C1 D1), C1 D15 (Cycle = 28 days)

  7. PK: Area Under the Concentration-time Curve (AUC) 0-6 Hours of Rebastinib (Part 1)

    Measure the AUC 0-6 hours

    Measured: Part 1: Cycle 1 Day 1 (C1 D1), C1 D15 (Cycle = 28 days)

Timeline

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

  1. First posted26 Jul 2018
  2. Study start25 Oct 2018
  3. Primary completion23 May 2022
  4. Study completion23 May 2022

Why it stopped: Development program terminated.

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
177 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03601897
Sponsor's protocol ID
DCC-2036-01-003
Status last verified
Dec 2024
First submitted
5 Jul 2018
Last updated
27 Dec 2024
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Rebastinib and Paclitaxel in people with Locally Advanced or Metastatic Solid Tumor, run by Deciphera Pharmaceuticals, LLC at 14 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 13 inclusion and 20 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: stopped early, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 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?

Yes. Results are posted in the registry (first posted 27 Dec 2024). 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?

Number of Participants With Adverse Events (time frame: Baseline up to 2.89 years). 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 NCT03601897.

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 27 Dec 2024.

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