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NCT03717415 · REGISTRY CONDITION SEARCH

A Study of Rebastinib (DCC-2036) in Combination With Carboplatin 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 carboplatin designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in participants 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

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Adverse Events

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outcome · POSTED

Objective Response Rate (ORR) (Dose Expansion Phase)

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outcome · POSTED

Objective Response Rate (ORR) (Dose Escalation Phase)

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outcome · POSTED

Duration of Response (DOR)

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outcome · POSTED

Time to Progression (TTP)

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outcome · POSTED

Progression-free-survival (PFS)

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

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

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outcome · POSTED

PK: Area Under the Concentration-time Curve 0-3 Hours (AUC 0-3 Hours) (Part 1)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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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 (Dose Escalation). Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor for which carboplatin is considered appropriate treatment. 3. Part 2 (Dose Expansion) * Previously treated, triple-negative breast cancer. * Recurrent platinum-sensitive ovarian cancer. * Histologically confirmed pleural or peritoneal malignant mesothelioma. 4. ECOG performance status 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 (whichever is shorter) prior to the first dose. 2. Not recovered from prior-treatment toxicities to Grade ≤1 or baseline. 3. Peripheral neuropathy of any etiology \>Grade 1. 4. Concurrent malignancy. 5. Known active 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. 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. Symptomatic venous thrombotic event. 13. Active infection ≥Grade 3. 14. Known HIV or HCV infection only if taking medications excluded per protocol, active 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 with rebastinib 50 milligram (mg) twice daily (BID) orally (PO) in 21-day cycles in combination with carboplatin administered by intravenous (IV) infusion at area under the curve (AUC)5 at Day 1 of each 21-day cycle.
    intervention Names
    1. Drug: Rebastinib
    2. Drug: Carboplatin
    label
    Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
    type
    EXPERIMENTAL
  2. description
    Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    intervention Names
    1. Drug: Rebastinib
    2. Drug: Carboplatin
    label
    Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
    type
    EXPERIMENTAL
  3. description
    Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
    intervention Names
    1. Drug: Rebastinib
    2. Drug: Carboplatin
    label
    Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
    type
    EXPERIMENTAL
  4. description
    Dose expansion in triple-negative breast cancer (TNBC) participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    intervention Names
    1. Drug: Rebastinib
    2. Drug: Carboplatin
    label
    Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
    type
    EXPERIMENTAL
  5. description
    Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    intervention Names
    1. Drug: Rebastinib
    2. Drug: Carboplatin
    label
    Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
    type
    EXPERIMENTAL
  6. description
    Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    intervention Names
    1. Drug: Rebastinib
    2. Drug: Carboplatin
    label
    Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
    type
    EXPERIMENTAL
  7. description
    Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    intervention Names
    1. Drug: Rebastinib
    2. Drug: Carboplatin
    label
    Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
    type
    EXPERIMENTAL
  8. description
    Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    intervention Names
    1. Drug: Rebastinib
    2. Drug: Carboplatin
    label
    Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
    type
    EXPERIMENTAL
  9. description
    Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    intervention Names
    1. Drug: Rebastinib
    2. Drug: Carboplatin
    label
    Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
    2. Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
    3. Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
    4. Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
    5. Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
    6. Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
    7. Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
    8. Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
    9. Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
    description
    Administered orally
    name
    Rebastinib
    other Names
    1. DCC-2036
    type
    DRUG
  2. arm Group Labels
    1. Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
    2. Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
    3. Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
    4. Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
    5. Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
    6. Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
    7. Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
    8. Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
    9. Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
    description
    Administered by IV infusion
    name
    Carboplatin
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
70
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Number of participants who experienced serious adverse events (SAE) and adverse events (AE).
    measure
    Number of Participants With Adverse Events
    time Frame
    Baseline up to 2.32 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. Disease progression 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) (Dose Expansion Phase)
    time Frame
    Time from CR or PR to disease progression or death due to any cause (Up to 1.53 years)
secondary Outcomes
  1. 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. Disease progression 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) (Dose Escalation Phase)
    time Frame
    Time from CR or PR to disease progression or death due to any cause (Up to 1.53 years)
  2. description
    Time from first partial response (PR) or complete response (CR) to disease progression (PD) or death due to any cause. Evaluation of radiographic disease assessment 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. Disease progression 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
    Duration of Response (DOR)
    time Frame
    Time from PR or CR to PD or Death due to Any Cause (up to 1.53 years)
  3. description
    Time from first dose of study drug to the first documentation of progressive disease (PD). Participants were considered to have progressive disease if they had documented progression based on radiologic assessment according to RECIST v1.1. RECIST v1.1 defined disease progression 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.
    measure
    Time to Progression (TTP)
    time Frame
    First Dose of Study Drug to PD (Up to 1.63 years)
  4. description
    Time from first dose of study drug to disease progression (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. Disease progression 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.
    measure
    Progression-free-survival (PFS)
    time Frame
    First Dose of Study Drug to PD or Death due to Any Cause (up to 1.63 years)
  5. description
    Time from baseline C1 D1 to date of death due to any cause. Participants who are still alive or who are lost to follow-up will be censored at the date of last contact.
    measure
    Overall Survival (OS)
    time Frame
    Baseline to death due to any cause (Up to 2.12 years)
  6. description
    Cmax of rebastinib
    measure
    Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Rebastinib (Part 1)
    time Frame
    Part 1: Cycle (C) 1 Day (D) 1, C2 D1 (Cycle = 21 Days)
  7. description
    Measure the AUC 0-3 hours
    measure
    PK: Area Under the Concentration-time Curve 0-3 Hours (AUC 0-3 Hours) (Part 1)
    time Frame
    Part 1: Cycle (C) 1 Day (D) 1, C2 D1 (Cycle = 21 Days)
Full study description
brief Summary
This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with carboplatin designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in participants with advanced or metastatic solid tumors.
Source references
Source notices and limitations
    Discovery and provenance
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      occurrences
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        exact text
        NCT03717415
        start
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      offset unit
      unicode_code_points
      query cond
      Malignant Mesothelioma
      query disease state id
      ds-malignant-mesothelioma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-malignant-mesothelioma-000.json
      source file sha256
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      source kind
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      source string sha256
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    Preserved source evidence · Not medical advice