Skip to content
Triangle logo TriangleGet started
← Study library

NCT03601897 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
TERMINATED
Registry last update
2024-12-27

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Number of Participants With Adverse Events

→

outcome · POSTED

Objective Response Rate (ORR) (Part 2 Expansion)

→

outcome · POSTED

Objective Response Rate (ORR) (Part 1 Escalation)

→

outcome · POSTED

Duration of Response (DOR)

→

outcome · POSTED

Time to Progression (TTP)

→

outcome · POSTED

Progression-free-survival (PFS)

→

outcome · POSTED

Overall Survival (OS)

→

outcome · POSTED

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

→

outcome · POSTED

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

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: 1. Male or female patients ≥18 years of age at the time of informed consent 2. Part 1 Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor for which paclitaxel is considered appropriate treatment 3. Part 2 * Triple-negative and Stage IV inflammatory breast cancer * Recurrent ovarian cancer * Recurrent, metastatic or high-risk endometrial cancer * Advanced (stage III or IV), or recurrent gynecological carcinosarcoma * Homologous or heterologous type carcinosarcoma (malignant mixed Mullerian tumor \[MMMT\] allowed 4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of ≤2 5. Able to provide an archival tumor tissue sample 6. Adequate organ function and bone marrow reserve 7. If a female of childbearing potential, must have a negative pregnancy test prior to enrollment 8. Patient must provide signed consent to participate in the study and is willing to comply with study-specific procedures Exclusion Criteria: 1. Received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose 2. Not recovered from prior-treatment toxicities to Grade ≤1 3. Peripheral neuropathy of any etiology \>Grade 1 4. Concurrent malignancy 5. Known active central nervous system (CNS) metastases 6. Use of systemic corticosteroids 7. Known retinal neovascularization, macular edema or macular degeneration 8. History or presence of clinically relevant cardiovascular abnormalities 9. QT interval corrected by Fridericia's formula (QTcF) \>450 ms in males or \>470 ms in females 10. Left ventricular ejection fraction (LVEF) \<50% at screening 11. Arterial thrombotic or embolic events 12. Venous thrombotic event 13. Active infection ≥Grade 3 14. Human immunodeficiency virus (HIV) or hepatitis C (HCV) infection only if taking medications excluded per protocol, active hepatitis B (HBV), or active HCV infection 15. Use of proton pump inhibitors 16. If female, the patient is pregnant or lactating 17. Major surgery 4 weeks prior to the first dose of study drug 18. Malabsorption syndrome or other illness which could affect oral absorption 19. Known allergy or hypersensitivity to any component of rebastinib or any of its excipients. 20. Any other clinically significant comorbidities
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Dose 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.
    intervention Names
    1. Drug: Rebastinib
    2. Drug: Paclitaxel
    label
    Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
    type
    EXPERIMENTAL
  2. description
    Dose 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.
    intervention Names
    1. Drug: Rebastinib
    2. Drug: Paclitaxel
    label
    Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
    type
    EXPERIMENTAL
  3. description
    Dose 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.
    intervention Names
    1. Drug: Rebastinib
    2. Drug: Paclitaxel
    label
    Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
    type
    EXPERIMENTAL
  4. description
    Dose 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.
    intervention Names
    1. Drug: Rebastinib
    2. Drug: Paclitaxel
    label
    Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
    type
    EXPERIMENTAL
  5. description
    Dose 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.
    intervention Names
    1. Drug: Rebastinib
    2. Drug: Paclitaxel
    label
    Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
    type
    EXPERIMENTAL
  6. description
    Dose 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.
    intervention Names
    1. Drug: Rebastinib
    2. Drug: Paclitaxel
    label
    Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
    type
    EXPERIMENTAL
  7. description
    Dose 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.
    intervention Names
    1. Drug: Rebastinib
    2. Drug: Paclitaxel
    label
    Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
    type
    EXPERIMENTAL
  8. description
    Dose 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.
    intervention Names
    1. Drug: Rebastinib
    2. Drug: Paclitaxel
    label
    Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
    type
    EXPERIMENTAL
  9. description
    Dose 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.
    intervention Names
    1. Drug: Rebastinib
    2. Drug: Paclitaxel
    label
    Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
    type
    EXPERIMENTAL
  10. description
    Dose 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.
    intervention Names
    1. Drug: Rebastinib
    2. Drug: Paclitaxel
    label
    Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
    type
    EXPERIMENTAL
  11. description
    Dose 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.
    intervention Names
    1. Drug: Rebastinib
    2. Drug: Paclitaxel
    label
    Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
    2. Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
    3. Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
    4. Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
    5. Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
    6. Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
    7. Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
    8. Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
    9. Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
    10. Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
    11. Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
    description
    Administered orally
    name
    Rebastinib
    other Names
    1. DCC-2036
    type
    DRUG
  2. arm Group Labels
    1. Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
    2. Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
    3. Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
    4. Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
    5. Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
    6. Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
    7. Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
    8. Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
    9. Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
    10. Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
    11. Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
    description
    Paclitaxel administered by IV infusion at 80 mg/m\^2
    name
    Paclitaxel
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
177
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Number of participants (pts) who experienced serious adverse events (SAE) and adverse events (AE).
    measure
    Number of Participants With Adverse Events
    time Frame
    Baseline up to 2.89 years
  2. description
    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.
    measure
    Objective Response Rate (ORR) (Part 2 Expansion)
    time Frame
    Baseline to PD or Death due to Any Cause (Up to 1.54 years)
secondary Outcomes
  1. description
    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
    measure
    Objective Response Rate (ORR) (Part 1 Escalation)
    time Frame
    Baseline to PD or Death due to Any Cause (Up to 0.92 years)
  2. description
    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.
    measure
    Duration of Response (DOR)
    time Frame
    Time from CR or PR to PD or Death due to Any Cause (Up to 1.54 years)
  3. description
    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.
    measure
    Time to Progression (TTP)
    time Frame
    First Dose of Study Drug to PD (Up to 2.61 years)
  4. description
    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.
    measure
    Progression-free-survival (PFS)
    time Frame
    First Dose of Study Drug to PD or Death due to Any Cause (Up to 2.61 years)
  5. description
    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.
    measure
    Overall Survival (OS)
    time Frame
    First Dose of Study Drug to Death due to Any Cause (Up to 2.82 years)
  6. description
    Measure the Cmax
    measure
    Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Rebastinib (Part 1)
    time Frame
    Part 1: Cycle 1 Day 1 (C1 D1), C1 D15 (Cycle = 28 days)
  7. description
    Measure the AUC 0-6 hours
    measure
    PK: Area Under the Concentration-time Curve (AUC) 0-6 Hours of Rebastinib (Part 1)
    time Frame
    Part 1: Cycle 1 Day 1 (C1 D1), C1 D15 (Cycle = 28 days)
Full study description
brief 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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-319cdb8716f0877d209a
      requested nct id
      NCT03601897
      primary nct id
      NCT03601897
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      21b84c01b125d04528c86b8a2e80343ce07b200dcda51c3b1328a536daf43d89
      payload sha256
      5acc00ba63fae8d7c55bf4469bf1c29bed14d5618813b9edfceccb0ec068ef98
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-319cdb8716f0877d209a
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT03601897
      occurrences
      1. context exact
        NCT03601897
        end
        11
        exact text
        NCT03601897
        start
        0
      offset unit
      unicode_code_points
      query cond
      Uterine Sarcoma
      query disease state id
      ds-uterine-sarcoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-uterine-sarcoma-000.json
      source file sha256
      21b84c01b125d04528c86b8a2e80343ce07b200dcda51c3b1328a536daf43d89
      source json pointer
      /studies/46/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      c5e25fca80c0d5037d8a169605a047d64a895738c711c0e60dec8bef60142c88

    Preserved source evidence · Not medical advice