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Completed

NCT Number: NCT01301716

A Study of the Safety and Pharmacology of GDC-0980 in Combination With Either Paclitaxel and Carboplatin (With or Without Bevacizumab) or Pemetrexed and Cisplatin in Patients With Solid Tumors

This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0980 administered with either paclitaxel and carboplatin (with or without bevacizumab) or pemetrexed and cisplatin to patients with locally advanced or metastatic solid tumors.

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Key information

Conditions

Solid Cancers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Madrid, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically documented, incurable, locally advanced, or metastatic solid malignancy
  • Adequate hematologic and end organ function
  • For female patients of childbearing potential and male patients with partners of childbearing potential, agreement to use an effective form of contraception and to continue its use for the duration of the study
  • Measurable disease per RECIST (Response Evaluable Criteria in Solid Tumors), with the exception of prostate cancer (two rising PSA Levels that meet the criteria of progression per PSA Working Group) and ovarian cancer (two rising CA-125 levels greater than the ULN)

Exclusion criteria

  • Current dyspnea at rest due to complications of advanced malignancy, or other conditions requiring continuous supplemental oxygen
  • Uncontrolled hypomagnesemia or hypokalemia
  • History of Grade >= 3 fasting hyperglycemia
  • Any condition requiring full-dose anticoagulants
  • Known HIV infection
  • Known untreated or active central nervous system (CNS) metastases
  • Pregnancy, lactation, or breastfeeding
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the first dose of study treatment or anticipation of need for major surgical procedure during the course of the study
  • For Arm B: Conditions that preclude the use of bevacizumab
  • For Arm C: Conditions that preclude the use of pemetrexed or cisplatin

Treatment and study plan

GDC-0980

Drug

Oral escalating dose

Bevacizumab

Drug

Intravenous repeating dose

carboplatin

Drug

Intravenous repeating dose

Cisplatin

Drug

intravenous repeating dose

paclitaxel

Drug

Intravenous repeating dose

Pemetrexed

Drug

intravenous repeating dose

Primary outcomes

  1. Incidence of adverse events

    Time frame: Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first

  2. Incidence of dose limiting toxicities (DLTs)

    Time frame: Up to 21 days from Last Patient In (LPI) in Stage 1 of study

  3. Nature of adverse events

    Time frame: Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first

  4. Nature of dose limiting toxicities (DLTs)

    Time frame: Up to 21 days from Last Patient In (LPI) in Stage 1 of study

  5. Severity of adverse events

    Time frame: Up to 30 days after last dose of study treatment

Secondary outcomes

  1. Total exposure

    Time frame: Up to 32 months or early study discontinuation

  2. Maximum plasma concentration

    Time frame: Up to 32 months or early study discontinuation

  3. Time to maximum observed plasma concentration

    Time frame: Up to 32 months or early study discontinuation

  4. Plasma half-life

    Time frame: Up to 32 months or early study discontinuation

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0980 in Combination With Either Paclitaxel and Carboplatin (With or Without Bevacizumab) or Pemetrexed and Cisplatin in Patients With Solid Tumors

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 23, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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