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Non-Squamous Non-Small Cell Lung CancerPhase 1NCT01995188

A Study to Evaluate the Safety and Pharmacology of DNIB0600A in Participants With Platinum-Sensitive Ovarian Cancer or Non-Squamous Non-small Cell Lung Cancer

A Phase 1 study testing Bevacizumab, Carboplatin and DNIB0600A in people with Non-Squamous Non-Small Cell Lung Cancer, run by Genentech, Inc. at 4 sites in United States.

Completed

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

Official record
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Trial summary

This open-label, multicenter, phase 1b study will evaluate the safety and pharmacokinetics of DNIB0600A in participants with platinum-sensitive ovarian cancer (PSOC) or Non-Squamous Non-small Cell Lung Cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Squamous Non-Small Cell Lung Cancer
What is being tested?
Bevacizumab, Carboplatin and DNIB0600A
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
4 sitesUnited States
Study dates
16 Dec 2013to 9 Nov 2016
Phase
Phase 1
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

  • Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.
  • Histologically documented epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that is platinum sensitive.
  • PSOC (i.e., epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer) with documented radiographic progression or relapse within 6 to 18 months of most recent platinum-based chemotherapy.
  • Female participants of childbearing potential must use effective contraception as defined by study protocol and cannot be pregnant or breastfeeding.
  • NSCLC-specific Inclusion Criteria:
  • Histological documentation of incurable, locally advanced, or metastatic non-squamous
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  • NSCLC that has progressed on prior treatment
  • Not more than 2 prior regimens in the metastatic setting, including one prior cytotoxic regimen and one prior non-cytotoxic regimen (prior treatment with adjuvant therapy within 6 months of recurrence is considered a treatment regimen in the metastatic setting).
  • For participants with a documented epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) rearrangement, one additional line of non-cytotoxic prior treatment will be permitted provided the therapy is a targeted agent against the EGFR mutation or ALK rearrangement.
  • For participants with lung cancer, centrally confirmed high expression of a sodium-dependent phosphate transporter (NaPi2b) by immunohistochemistry (IHC) is required (i.e., IHC 2+ or 3+).

Who cannot join

  • Anti-tumor therapy of any kind or major surgery within 4 weeks prior to Day 1.
  • For ovarian cancer participants only, platinum-based chemotherapy within 6 months prior to Day 1.
  • For ovarian cancer participants only, platinum treatment with more than two platinum-based chemotherapy regiments or more than four anti-cancer regimens, overall, for the treatment of ovarian cancer.
  • Palliative radiation within 2 weeks prior to Day 1.
  • Toxicity (except alopecia and anorexia) from prior therapy or neuropathy of grades > 1.
  • Evidence of any significant disease or condition that could affect compliance with the protocol or interpretation of results.
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  • Known active infection (except fungal nail infections).
  • History of liver disease or human immunodeficiency virus (HIV).
  • Other malignancy within the last 5 years, except for adequately treated or controlled carcinoma in situ of the cervix or skin cancer or primary endometrial cancer of stage </= 1B.
  • Untreated or active central nervous system (CNS) metastases.
  • Prior treatment with NaPi2b- targeted therapy.
  • Bevacizumab-Specific Exclusion Criteria (for Participants in Second Ovarian
  • Expansion Cohort Only):
  • Inadequately controlled hypertension or history of hypertensive crisis or encephalopathy.
  • History of heart problems or thrombosis within 6 months prior to study start.
  • History of stroke within 6 months prior to study enrollment.
  • History of significant vascular disease.
  • History of expectoration of blood within 1 month prior to study start or blood clotting problems.
  • Core biopsy or other minor surgical procedure within 7 days prior to study start
  • Serious and non-healing wound, active ulcer, or untreated bone fracture.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Massachusetts General Hospital.

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Inst.

    Boston, Massachusetts, 02115

  • The Sarah Cannon Research Inst

    Nashville, Tennessee, 37203

  • The University of Oklahoma

    Oklahoma City, Oklahoma, 73104

Other trials in United States

About this study

Official title: A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of DNIB0600A in Combination With Carboplatin (With or Without Bevacizumab) in Patients With Platinum-Sensitive Ovarian Cancer or Non-Squamous Non-small Cell Lung Cancer

This open-label, multicenter, phase 1b study will evaluate the safety and pharmacokinetics of DNIB0600A in participants with platinum-sensitive ovarian cancer (PSOC) or Non-Squamous Non-small Cell Lung Cancer (NSCLC). The maximum tolerated dose of intravenously infused DNIB0600A in combination with carboplatin will be determined in escalating dose cohorts. The combination of DNIB0600A and carboplatin will then be evaluated with and without bevacizumab [Avastin] in three dose expansion cohorts.

Being tested
Bevacizumab, Carboplatin, DNIB0600A

What participants receive

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

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab 15 milligrams per kilogram (mg/kg) administered via IV infusion on Day 1 of each 21-day cycle until disease progression or death, whichever occurs first.

  • CarboplatinDrug

    Carboplatin fixed dose of AUC=6 mg/mL*min administered by IV infusion on Day 1 of each 21-day dose escalation and expansion cycles. Carboplatin will be administered for a maximum of 6 cycles or until disease progression or unacceptable toxicity, whichever is first.

  • DNIB0600ADrug

    DNIB0600A at an initial dose of 1.2 mg/kg will be administered via IV infusion further following a dose-escalation until DLT under consultation of the investigator on Day 1 of 21 day dose-escalation cycle. RP2D will be administered further in dose-expansion for until disease progression or death, whichever occurs first.

Study groups in NCT01995188
Study groupRoleWhat they receive
Dose Escalation Cohort: DNIB0600A+CarboplatinExperimentalDNIB0600A at an initial dose of 1.2 milligrams per kilogram (mg/kg) will be administered via intravenous (IV) infusion further following a dose-escalation until DLT under consultation of the investigator in combination with Carboplatin fixed dose of area under the curve (AUC)=6 mg/milliliter(mL)*minute (min) administered by IV infusion on Day 1 of a 21-day cycle.
Receives: Drug: Carboplatin; Drug: DNIB0600A
NSCLC Dose Expansion Cohort: DNIB0600A+CarboplatinExperimentalRecommended phase 2 dose (RP2D) of DNIB0600A administered via IV infusion in combination with Carboplatin, AUC=6 mg/mL*min administered via IV infusion on Day 1 of each 21-day cycle in participants with NSCLC until disease progression or death, whichever occurs first.
Receives: Drug: DNIB0600A
PSOC Dose Expansion Cohort: DNIB0600A+CarboplatinExperimentalRP2D of DNIB0600A administered via IV infusion in combination with AUC=6 mg/mL*min administered via IV infusion on Day 1 of each 21-day cycle in participants with PSOC until disease progression or death, whichever occurs first.
Receives: Drug: Carboplatin; Drug: DNIB0600A
PSOC Dose Expansion Cohort: DNIB0600A+Carboplatin+BevacizumabExperimentalRP2D of DNIB0600A administered via IV infusion in combination with Carboplatin, AUC=6 mg/mL*min and Bevacizumab 15 milligrams per kilogram (mg/kg) administered via IV infusion on Day 1 of each 21-day cycle in participants with PSOC until disease progression or death, whichever occurs first.
Receives: Drug: Bevacizumab; Drug: Carboplatin; Drug: DNIB0600A

What is being measured

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

  1. Number of Participants with Dose-limiting Toxicities (DLTs)

    Measured: 21 days

  2. Number of Participants with Adverse events (AE) and Serious Adverse Events (SAEs)

    Measured: Day 1 until 30 days after the last-infusion (up to approximately 3 years)

  3. Number of Participants with Anti-DNIB0600A Antibodies

    Measured: Pre-infusion (0 hour) at Day 1 of Cycle 1, 2, 3, 4 (each cycle of 21 days), 30 days after last infusion (up to approximately 3 years)

Secondary outcomes (9)

  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] of DNIB0600A

    Measured: Pre-infusion (0 hour), hour 0.5,1 post-infusion Cycle 1 (each cycle= 28 days); 7, 14 days post-infusion of Cycle 1 (Day 8, 15 respectively); Day 1 of Cycle 2 and subsequent cycles up to last dose; 30 days after last dose (up to approximately 3 years)

  2. Maximum Observed Plasma Concentration (Cmax)

    Measured: Pre-infusion (0 hour), hour 0.5,1 post-infusion Cycle 1 (each cycle= 28 days); 7, 14 days post-infusion of Cycle 1 (Day 8, 15 respectively); Day 1 of Cycle 2 and subsequent cycles up to last dose; 30 days after last dose (up to approximately 3 years)

  3. Minimum Observed Plasma Trough Concentration (Cmin)

    Measured: Pre-infusion (0 hour), hour 0.5,1 post-infusion Cycle 1 (each cycle= 28 days); 7, 14 days post-infusion of Cycle 1 (Day 8, 15 respectively); Day 1 of Cycle 2 and subsequent cycles up to last dose; 30 days after last dose (up to approximately 3 years)

  4. Systemic Clearance (CL)

    Measured: Pre-infusion (0 hour), hour 0.5,1 post-infusion Cycle 1 (each cycle= 28 days); 7, 14 days post-infusion of Cycle 1 (Day 8, 15 respectively); Day 1 of Cycle 2 and subsequent cycles up to last dose; 30 days after last dose (up to approximately 3 years)

  5. Volume of Distribution at Steady State (Vss)

    Measured: Pre-infusion (0 hour), hour 0.5,1 post-infusion Cycle 1 (each cycle= 28 days); 7, 14 days post-infusion of Cycle 1 (Day 8, 15 respectively); Day 1 of Cycle 2 and subsequent cycles up to last dose; 30 days after last dose (up to approximately 3 years)

  6. Plasma Decay Half-Life (t1/2)

    Measured: Pre-infusion (0 hour), hour 0.5,1 post-infusion Cycle 1 (each cycle= 28 days); 7, 14 days post-infusion of Cycle 1 (Day 8, 15 respectively); Day 1 of Cycle 2 and subsequent cycles up to last dose; 30 days after last dose (up to approximately 3 years)

  7. Percentage of Participants With Objective Response as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

    Measured: From screening thereafter every 2 cycles (from Cycle 2 to Cycle 16) or every 4 cycles (from Cycle 10) until disease progression or death (up to approximately 3 years)

  8. Duration of Objective Response Rate as Assessed by RECIST v1.1

    Measured: From screening thereafter every 2 cycles (from Cycle 2 to Cycle 16) or every 4 cycles (from Cycle 10) until disease progression or death (up to approximately 3 years)

  9. Progression Free Survival (PFS) as Assessed by RECIST v1.1

    Measured: Day 1 to the first occurrence of disease progression or death within 30 days of the last administration of study drug, whichever occurs first (up to approximately 3 years)

Timeline

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

  1. First posted26 Nov 2013 (estimated)
  2. Study start16 Dec 2013
  3. Primary completion9 Nov 2016
  4. Study completion9 Nov 2016

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01995188
Sponsor's protocol ID
GO29006
Status last verified
Oct 2017
First submitted
15 Nov 2013
Last updated
4 Oct 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bevacizumab, Carboplatin and DNIB0600A in people with Non-Squamous Non-Small Cell Lung Cancer, run by Genentech, Inc. 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 10 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: finished, as of the sponsor's last update on 4 Oct 2017. 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 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.

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?

Number of Participants with Dose-limiting Toxicities (DLTs) (time frame: 21 days). 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 NCT01995188.

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 4 Oct 2017.

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